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Fifty Years Later: Preterm Birth Shows Complex Pattern of Cardiovascular Outcomes
TOPLINE:
Adults aged 50 years who were born preterm have a higher risk for hypertension but lower risk for cardiovascular events than those born at term, with similar risks for diabetes, prediabetes, and dyslipidemia between groups.
METHODOLOGY:
- The researchers conducted a prospective cohort study of the Auckland Steroid Trial — the first randomized trial of antenatal corticosteroids (betamethasone) for women who were at risk for preterm birth, conducted in Auckland, New Zealand, between December 1969 and February 1974.
- They analyzed 470 participants, including 424 survivors recruited between January 2020 and May 2022 and 46 participants who died after infancy.
- The outcomes for 326 participants born preterm (mean age, 49.4 years) and 144 participants born at term (mean age, 49.2 years) were assessed using either a questionnaire, administrative datasets, or both.
- The primary outcome was a composite of cardiovascular events or risk factors, defined as a history of a major adverse cardiovascular event or the presence of at least one cardiovascular risk factor, including diabetes mellitus, prediabetes, treated dyslipidemia, and treated hypertension.
- The secondary outcomes included respiratory, mental health, educational, and other health outcomes, as well as components of the primary outcomes.
TAKEAWAY:
- The composite of cardiovascular events or risk factors occurred in 34.5% of participants born preterm and 29.9% of participants born at term, with no differences in the risk factor components.
- The risk for cardiovascular events was lower in participants born preterm than in those born at term (adjusted relative risk [aRR], 0.33; P = .013).
- The participants born preterm had a higher risk for high blood pressure (aRR, 1.74; P = .007) and the composite of treated hypertension or self-reported diagnosis of high blood pressure (aRR, 1.63; P = .010) than those born at term.
- From randomization to the 50-year follow-up, death from any cause was more common in those born preterm than in those born at term (aRR, 2.29; P < .0001), whereas the diagnosis or treatment of a mental health disorder was less common (P = .007); no differences were observed between the groups for other outcomes.
IN PRACTICE:
“Those aware of being born preterm also may be more likely to seek preventive treatments, potentially resulting in a reduced risk of cardiovascular disease but a greater prevalence of risk factors if defined by a treatment such as treated dyslipidemia or treated hypertension,” the authors wrote.
“In this cohort, the survival advantage of the term-born control group abated after infancy, with a higher all-cause mortality rate, compared with that of the group born preterm,” wrote Jonathan S. Litt, MD, MPH, ScD, and Henning Tiemeier, MD, PhD, in a related commentary published in Pediatrics.
SOURCE:
The study was led by Anthony G. B. Walters, MBChB, Liggins Institute, Auckland, New Zealand. It was published online on December 16, 2024, in Pediatrics .
LIMITATIONS:
The small sample size limited the ability to detect subtle differences between groups and the validity of subgroup analyses. Attrition bias may have occurred because of low follow-up rates among presumed survivors. Bias could have been introduced because of lack of consent for access to the administrative dataset or from missing data from the participants in the questionnaire. The lack of in-person assessments for blood pressure and blood tests, resulting from geographical dispersion over 50 years, may have led to underestimation of some outcomes. Additionally, as most participants were born moderately or late preterm, with a median gestational age of 34.1 weeks, findings may not be generalizable to those born preterm at earlier gestational ages.
DISCLOSURES:
The study was supported in part by the Aotearoa Foundation, the Auckland Medical Research Foundation, Cure Kids New Zealand, and the Health Research Council of New Zealand. The authors of both the study and the commentary reported no conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
Adults aged 50 years who were born preterm have a higher risk for hypertension but lower risk for cardiovascular events than those born at term, with similar risks for diabetes, prediabetes, and dyslipidemia between groups.
METHODOLOGY:
- The researchers conducted a prospective cohort study of the Auckland Steroid Trial — the first randomized trial of antenatal corticosteroids (betamethasone) for women who were at risk for preterm birth, conducted in Auckland, New Zealand, between December 1969 and February 1974.
- They analyzed 470 participants, including 424 survivors recruited between January 2020 and May 2022 and 46 participants who died after infancy.
- The outcomes for 326 participants born preterm (mean age, 49.4 years) and 144 participants born at term (mean age, 49.2 years) were assessed using either a questionnaire, administrative datasets, or both.
- The primary outcome was a composite of cardiovascular events or risk factors, defined as a history of a major adverse cardiovascular event or the presence of at least one cardiovascular risk factor, including diabetes mellitus, prediabetes, treated dyslipidemia, and treated hypertension.
- The secondary outcomes included respiratory, mental health, educational, and other health outcomes, as well as components of the primary outcomes.
TAKEAWAY:
- The composite of cardiovascular events or risk factors occurred in 34.5% of participants born preterm and 29.9% of participants born at term, with no differences in the risk factor components.
- The risk for cardiovascular events was lower in participants born preterm than in those born at term (adjusted relative risk [aRR], 0.33; P = .013).
- The participants born preterm had a higher risk for high blood pressure (aRR, 1.74; P = .007) and the composite of treated hypertension or self-reported diagnosis of high blood pressure (aRR, 1.63; P = .010) than those born at term.
- From randomization to the 50-year follow-up, death from any cause was more common in those born preterm than in those born at term (aRR, 2.29; P < .0001), whereas the diagnosis or treatment of a mental health disorder was less common (P = .007); no differences were observed between the groups for other outcomes.
IN PRACTICE:
“Those aware of being born preterm also may be more likely to seek preventive treatments, potentially resulting in a reduced risk of cardiovascular disease but a greater prevalence of risk factors if defined by a treatment such as treated dyslipidemia or treated hypertension,” the authors wrote.
“In this cohort, the survival advantage of the term-born control group abated after infancy, with a higher all-cause mortality rate, compared with that of the group born preterm,” wrote Jonathan S. Litt, MD, MPH, ScD, and Henning Tiemeier, MD, PhD, in a related commentary published in Pediatrics.
SOURCE:
The study was led by Anthony G. B. Walters, MBChB, Liggins Institute, Auckland, New Zealand. It was published online on December 16, 2024, in Pediatrics .
LIMITATIONS:
The small sample size limited the ability to detect subtle differences between groups and the validity of subgroup analyses. Attrition bias may have occurred because of low follow-up rates among presumed survivors. Bias could have been introduced because of lack of consent for access to the administrative dataset or from missing data from the participants in the questionnaire. The lack of in-person assessments for blood pressure and blood tests, resulting from geographical dispersion over 50 years, may have led to underestimation of some outcomes. Additionally, as most participants were born moderately or late preterm, with a median gestational age of 34.1 weeks, findings may not be generalizable to those born preterm at earlier gestational ages.
DISCLOSURES:
The study was supported in part by the Aotearoa Foundation, the Auckland Medical Research Foundation, Cure Kids New Zealand, and the Health Research Council of New Zealand. The authors of both the study and the commentary reported no conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
Adults aged 50 years who were born preterm have a higher risk for hypertension but lower risk for cardiovascular events than those born at term, with similar risks for diabetes, prediabetes, and dyslipidemia between groups.
METHODOLOGY:
- The researchers conducted a prospective cohort study of the Auckland Steroid Trial — the first randomized trial of antenatal corticosteroids (betamethasone) for women who were at risk for preterm birth, conducted in Auckland, New Zealand, between December 1969 and February 1974.
- They analyzed 470 participants, including 424 survivors recruited between January 2020 and May 2022 and 46 participants who died after infancy.
- The outcomes for 326 participants born preterm (mean age, 49.4 years) and 144 participants born at term (mean age, 49.2 years) were assessed using either a questionnaire, administrative datasets, or both.
- The primary outcome was a composite of cardiovascular events or risk factors, defined as a history of a major adverse cardiovascular event or the presence of at least one cardiovascular risk factor, including diabetes mellitus, prediabetes, treated dyslipidemia, and treated hypertension.
- The secondary outcomes included respiratory, mental health, educational, and other health outcomes, as well as components of the primary outcomes.
TAKEAWAY:
- The composite of cardiovascular events or risk factors occurred in 34.5% of participants born preterm and 29.9% of participants born at term, with no differences in the risk factor components.
- The risk for cardiovascular events was lower in participants born preterm than in those born at term (adjusted relative risk [aRR], 0.33; P = .013).
- The participants born preterm had a higher risk for high blood pressure (aRR, 1.74; P = .007) and the composite of treated hypertension or self-reported diagnosis of high blood pressure (aRR, 1.63; P = .010) than those born at term.
- From randomization to the 50-year follow-up, death from any cause was more common in those born preterm than in those born at term (aRR, 2.29; P < .0001), whereas the diagnosis or treatment of a mental health disorder was less common (P = .007); no differences were observed between the groups for other outcomes.
IN PRACTICE:
“Those aware of being born preterm also may be more likely to seek preventive treatments, potentially resulting in a reduced risk of cardiovascular disease but a greater prevalence of risk factors if defined by a treatment such as treated dyslipidemia or treated hypertension,” the authors wrote.
“In this cohort, the survival advantage of the term-born control group abated after infancy, with a higher all-cause mortality rate, compared with that of the group born preterm,” wrote Jonathan S. Litt, MD, MPH, ScD, and Henning Tiemeier, MD, PhD, in a related commentary published in Pediatrics.
SOURCE:
The study was led by Anthony G. B. Walters, MBChB, Liggins Institute, Auckland, New Zealand. It was published online on December 16, 2024, in Pediatrics .
LIMITATIONS:
The small sample size limited the ability to detect subtle differences between groups and the validity of subgroup analyses. Attrition bias may have occurred because of low follow-up rates among presumed survivors. Bias could have been introduced because of lack of consent for access to the administrative dataset or from missing data from the participants in the questionnaire. The lack of in-person assessments for blood pressure and blood tests, resulting from geographical dispersion over 50 years, may have led to underestimation of some outcomes. Additionally, as most participants were born moderately or late preterm, with a median gestational age of 34.1 weeks, findings may not be generalizable to those born preterm at earlier gestational ages.
DISCLOSURES:
The study was supported in part by the Aotearoa Foundation, the Auckland Medical Research Foundation, Cure Kids New Zealand, and the Health Research Council of New Zealand. The authors of both the study and the commentary reported no conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Clinicians More Likely to Flag Black Kids’ Injuries as Abuse
TOPLINE:
Among children with traumatic injury, those of Black ethnicity are more likely than those of White ethnicity to be suspected of experiencing child abuse. Young patients and those from low socioeconomic backgrounds also face an increased likelihood of suspicion for child abuse (SCA).
METHODOLOGY:
- Researchers analyzed data on pediatric patients admitted to hospitals after sustaining a traumatic injury between 2006 and 2016 using the Kids’ Inpatient Database (KID) to investigate racial and ethnic disparities in cases in which SCA codes from the 9th and 10th editions of the International Classification of Diseases were used.
- The analysis included a weighted total of 634,309 pediatric patients with complete data, comprising 13,579 patients in the SCA subgroup and 620,730 in the non-SCA subgroup.
- Patient demographics, injury severity, and hospitalization characteristics were classified by race and ethnicity.
- The primary outcome was differences in racial and ethnic composition between the SCA and non-SCA groups, as well as compared with the overall US population using 2010 US Census data.
TAKEAWAY:
- Black patients had 75% higher odds of having a SCA code, compared with White patients; the latter ethnicity was relatively underrepresented in the SCA subgroup, compared with the distribution reported by the US Census.
- Black patients had 10% higher odds of having a SCA code (odds ratio, 1.10; P =.004) than White patients, after socioeconomic factors such as insurance type, household income based on zip code, and injury severity were controlled for.
- Black patients in the SCA subgroup experienced a 26.5% (P < .001) longer hospital stay for mild to moderate injuries and a 40.1% (P < .001) longer stay for serious injuries compared with White patients.
- Patients in the SCA subgroup were significantly younger (mean, 1.70 years vs 9.70 years), were more likely to have Medicaid insurance (76.6% vs 42.0%), and had higher mortality rates (5.6% vs 1.0%) than those in the non-SCA subgroup; they were also more likely to come from lower socioeconomic backgrounds and present with more severe injuries.
IN PRACTICE:
“However, we can identify and appropriately respond to patients with potential child abuse in an equitable way by using clinical decision support tools, seeking clinical consultation of child abuse pediatricians, practicing cultural humility, and enhancing the education and training for health care professionals on child abuse recognition, response, and prevention,” Allison M. Jackson, MD, MPH, of the Child and Adolescent Protection Center at Children’s National Hospital, Washington, DC, wrote in an accompanying editorial.
SOURCE:
The study was led by Fereshteh Salimi-Jazi, MD, of Stanford University School of Medicine in California. It was published online on December 18, 2024, in JAMA Network Open.
LIMITATIONS:
The study relied on data from KID, which has limitations such as potential coding errors and the inability to follow patients over time. The database combines race and ethnicity in a single field as well. The study only included hospitalized patients, which may not represent all clinician suspicions of SCA cases.
DISCLOSURES:
This study was supported by a grant from the National Center for Advancing Translational Sciences of the National Institutes of Health. The authors reported no relevant conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
Among children with traumatic injury, those of Black ethnicity are more likely than those of White ethnicity to be suspected of experiencing child abuse. Young patients and those from low socioeconomic backgrounds also face an increased likelihood of suspicion for child abuse (SCA).
METHODOLOGY:
- Researchers analyzed data on pediatric patients admitted to hospitals after sustaining a traumatic injury between 2006 and 2016 using the Kids’ Inpatient Database (KID) to investigate racial and ethnic disparities in cases in which SCA codes from the 9th and 10th editions of the International Classification of Diseases were used.
- The analysis included a weighted total of 634,309 pediatric patients with complete data, comprising 13,579 patients in the SCA subgroup and 620,730 in the non-SCA subgroup.
- Patient demographics, injury severity, and hospitalization characteristics were classified by race and ethnicity.
- The primary outcome was differences in racial and ethnic composition between the SCA and non-SCA groups, as well as compared with the overall US population using 2010 US Census data.
TAKEAWAY:
- Black patients had 75% higher odds of having a SCA code, compared with White patients; the latter ethnicity was relatively underrepresented in the SCA subgroup, compared with the distribution reported by the US Census.
- Black patients had 10% higher odds of having a SCA code (odds ratio, 1.10; P =.004) than White patients, after socioeconomic factors such as insurance type, household income based on zip code, and injury severity were controlled for.
- Black patients in the SCA subgroup experienced a 26.5% (P < .001) longer hospital stay for mild to moderate injuries and a 40.1% (P < .001) longer stay for serious injuries compared with White patients.
- Patients in the SCA subgroup were significantly younger (mean, 1.70 years vs 9.70 years), were more likely to have Medicaid insurance (76.6% vs 42.0%), and had higher mortality rates (5.6% vs 1.0%) than those in the non-SCA subgroup; they were also more likely to come from lower socioeconomic backgrounds and present with more severe injuries.
IN PRACTICE:
“However, we can identify and appropriately respond to patients with potential child abuse in an equitable way by using clinical decision support tools, seeking clinical consultation of child abuse pediatricians, practicing cultural humility, and enhancing the education and training for health care professionals on child abuse recognition, response, and prevention,” Allison M. Jackson, MD, MPH, of the Child and Adolescent Protection Center at Children’s National Hospital, Washington, DC, wrote in an accompanying editorial.
SOURCE:
The study was led by Fereshteh Salimi-Jazi, MD, of Stanford University School of Medicine in California. It was published online on December 18, 2024, in JAMA Network Open.
LIMITATIONS:
The study relied on data from KID, which has limitations such as potential coding errors and the inability to follow patients over time. The database combines race and ethnicity in a single field as well. The study only included hospitalized patients, which may not represent all clinician suspicions of SCA cases.
DISCLOSURES:
This study was supported by a grant from the National Center for Advancing Translational Sciences of the National Institutes of Health. The authors reported no relevant conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
Among children with traumatic injury, those of Black ethnicity are more likely than those of White ethnicity to be suspected of experiencing child abuse. Young patients and those from low socioeconomic backgrounds also face an increased likelihood of suspicion for child abuse (SCA).
METHODOLOGY:
- Researchers analyzed data on pediatric patients admitted to hospitals after sustaining a traumatic injury between 2006 and 2016 using the Kids’ Inpatient Database (KID) to investigate racial and ethnic disparities in cases in which SCA codes from the 9th and 10th editions of the International Classification of Diseases were used.
- The analysis included a weighted total of 634,309 pediatric patients with complete data, comprising 13,579 patients in the SCA subgroup and 620,730 in the non-SCA subgroup.
- Patient demographics, injury severity, and hospitalization characteristics were classified by race and ethnicity.
- The primary outcome was differences in racial and ethnic composition between the SCA and non-SCA groups, as well as compared with the overall US population using 2010 US Census data.
TAKEAWAY:
- Black patients had 75% higher odds of having a SCA code, compared with White patients; the latter ethnicity was relatively underrepresented in the SCA subgroup, compared with the distribution reported by the US Census.
- Black patients had 10% higher odds of having a SCA code (odds ratio, 1.10; P =.004) than White patients, after socioeconomic factors such as insurance type, household income based on zip code, and injury severity were controlled for.
- Black patients in the SCA subgroup experienced a 26.5% (P < .001) longer hospital stay for mild to moderate injuries and a 40.1% (P < .001) longer stay for serious injuries compared with White patients.
- Patients in the SCA subgroup were significantly younger (mean, 1.70 years vs 9.70 years), were more likely to have Medicaid insurance (76.6% vs 42.0%), and had higher mortality rates (5.6% vs 1.0%) than those in the non-SCA subgroup; they were also more likely to come from lower socioeconomic backgrounds and present with more severe injuries.
IN PRACTICE:
“However, we can identify and appropriately respond to patients with potential child abuse in an equitable way by using clinical decision support tools, seeking clinical consultation of child abuse pediatricians, practicing cultural humility, and enhancing the education and training for health care professionals on child abuse recognition, response, and prevention,” Allison M. Jackson, MD, MPH, of the Child and Adolescent Protection Center at Children’s National Hospital, Washington, DC, wrote in an accompanying editorial.
SOURCE:
The study was led by Fereshteh Salimi-Jazi, MD, of Stanford University School of Medicine in California. It was published online on December 18, 2024, in JAMA Network Open.
LIMITATIONS:
The study relied on data from KID, which has limitations such as potential coding errors and the inability to follow patients over time. The database combines race and ethnicity in a single field as well. The study only included hospitalized patients, which may not represent all clinician suspicions of SCA cases.
DISCLOSURES:
This study was supported by a grant from the National Center for Advancing Translational Sciences of the National Institutes of Health. The authors reported no relevant conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Allergic Contact Dermatitis: New Culprits
New allergens responsible for contact dermatitis emerge regularly. During the Dermatology Days of Paris 2024 conference, Angèle Soria, MD, PhD, a dermatologist at Tenon Hospital in Paris, France, outlined four major categories driving this trend. Among them are (meth)acrylates found in nail cosmetics used in salons or do-it-yourself false nail kits that can be bought online.
Isothiazolinones
a preservative used in many cosmetics; (meth)acrylates; essential oils; and epoxy resins used in industry and leisure activities.
Around 15 years ago, parabens, commonly used as preservatives in cosmetics, were identified as endocrine disruptors. In response, they were largely replaced by newer preservatives, notably MI. However, this led to a proliferation of allergic contact dermatitis in Europe between 2010 and 2013.
“About 10% of the population that we tested showed allergies to these preservatives, primarily found in cosmetics,” explained Soria. Since 2015, the use of MI in leave-on cosmetics has been prohibited in Europe and its concentration restricted in rinse-off products. However, cosmetics sold online from outside Europe may not comply with these regulations.
MI is also present in water-based paints to prevent mold. “A few years ago, we started seeing patients with facial angioedema, sometimes combined with asthma, caused by these isothiazolinone preservatives, including in patients who are not professional painters,” said Soria. More recently, attention has shifted to MI’s presence in household cleaning products. A 2020 Spanish study found MI in 76% of 34 analyzed cleaning products.
MI-based fungicides are also used to treat leather during transport, which can lead to contact allergies among professionals and consumers alike. Additionally, MI has been identified in children’s toys, including slime gels, and in florists’ gel cubes used to preserve flowers.
“We are therefore surrounded by these preservatives, which are no longer only in cosmetics,” warned the dermatologist.
(Meth)acrylates
Another major allergen category is (meth)acrylates, responsible for many cases of allergic contact dermatitis. Acrylates and their derivatives are widely used in everyday items. They are low–molecular weight monomers, sensitizing on contact with the skin. Their polymerized forms include materials like Plexiglas.
“We are currently witnessing an epidemic of contact dermatitis in the general population, mainly due to nail cosmetics, such as semipermanent nail polishes and at-home false nail kits,” reported Soria. Nail cosmetics account for 97% of new sensitization cases involving (meth)acrylates. These allergens often cause severe dermatitis, prompting the European Union to mandate labeling in 2020, warning that these products are “for professional use only” and can “cause allergic reactions.”
Beyond nail cosmetics, these allergens are also found in dental products (such as trays), ECG electrodes, prosthetics, glucose sensors, surgical adhesives, and some electronic devices like earbuds and phone screens. Notably, patients sensitized to acrylates via nail kits may experience reactions during dental treatments involving acrylates.
Investigating Essential Oil Use
Essential oils, distinct from vegetable oils like almond or argan, are another known allergen. Often considered risk-free due to their “natural” label, these products are widely used topically, orally, or via inhalation for various purposes, such as treating respiratory infections or creating relaxing atmospheres. However, essential oils contain fragrant molecules like terpenes, which can become highly allergenic over time, especially after repeated exposure.
Soria emphasized the importance of asking patients about their use of essential oils, especially tea tree and lavender oils, which are commonly used but rarely mentioned by patients unless prompted.
Epoxy Resins in Recreational Use
Epoxy resins are a growing cause of contact allergies, not just in professional settings such as aeronautics and construction work but also increasingly in recreational activities. Soria highlighted the case of a 12-year-old girl hospitalized for severe facial edema after engaging in resin crafts inspired by TikTok. For 6 months, she had been creating resin objects, such as bowls and cutting boards, using vinyl gloves and a Filtering FacePiece 2 mask under adult supervision.
“The growing popularity and online availability of epoxy resins mean that allergic reactions should now be considered even in nonprofessional contexts,” warned Soria.
Clinical Approach
When dermatologists suspect allergic contact dermatitis, the first step is to treat the condition with corticosteroid creams. This is followed by a detailed patient interview to identify suspected allergens in products they’ve used.
Patch testing is then conducted to confirm the allergen. Small chambers containing potential allergens are applied to the upper back for 48 hours without removal. Results are read 2-5 days later, with some cases requiring a 7-day follow-up.
The patient’s occupation is an important factor, as certain professions, such as hairdressing, healthcare, or beauty therapy, are known to trigger allergic contact dermatitis. Similarly, certain hobbies may also play a role.
A thorough approach ensures accurate diagnosis and targeted prevention strategies.
This story was translated from Medscape’s French edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
New allergens responsible for contact dermatitis emerge regularly. During the Dermatology Days of Paris 2024 conference, Angèle Soria, MD, PhD, a dermatologist at Tenon Hospital in Paris, France, outlined four major categories driving this trend. Among them are (meth)acrylates found in nail cosmetics used in salons or do-it-yourself false nail kits that can be bought online.
Isothiazolinones
a preservative used in many cosmetics; (meth)acrylates; essential oils; and epoxy resins used in industry and leisure activities.
Around 15 years ago, parabens, commonly used as preservatives in cosmetics, were identified as endocrine disruptors. In response, they were largely replaced by newer preservatives, notably MI. However, this led to a proliferation of allergic contact dermatitis in Europe between 2010 and 2013.
“About 10% of the population that we tested showed allergies to these preservatives, primarily found in cosmetics,” explained Soria. Since 2015, the use of MI in leave-on cosmetics has been prohibited in Europe and its concentration restricted in rinse-off products. However, cosmetics sold online from outside Europe may not comply with these regulations.
MI is also present in water-based paints to prevent mold. “A few years ago, we started seeing patients with facial angioedema, sometimes combined with asthma, caused by these isothiazolinone preservatives, including in patients who are not professional painters,” said Soria. More recently, attention has shifted to MI’s presence in household cleaning products. A 2020 Spanish study found MI in 76% of 34 analyzed cleaning products.
MI-based fungicides are also used to treat leather during transport, which can lead to contact allergies among professionals and consumers alike. Additionally, MI has been identified in children’s toys, including slime gels, and in florists’ gel cubes used to preserve flowers.
“We are therefore surrounded by these preservatives, which are no longer only in cosmetics,” warned the dermatologist.
(Meth)acrylates
Another major allergen category is (meth)acrylates, responsible for many cases of allergic contact dermatitis. Acrylates and their derivatives are widely used in everyday items. They are low–molecular weight monomers, sensitizing on contact with the skin. Their polymerized forms include materials like Plexiglas.
“We are currently witnessing an epidemic of contact dermatitis in the general population, mainly due to nail cosmetics, such as semipermanent nail polishes and at-home false nail kits,” reported Soria. Nail cosmetics account for 97% of new sensitization cases involving (meth)acrylates. These allergens often cause severe dermatitis, prompting the European Union to mandate labeling in 2020, warning that these products are “for professional use only” and can “cause allergic reactions.”
Beyond nail cosmetics, these allergens are also found in dental products (such as trays), ECG electrodes, prosthetics, glucose sensors, surgical adhesives, and some electronic devices like earbuds and phone screens. Notably, patients sensitized to acrylates via nail kits may experience reactions during dental treatments involving acrylates.
Investigating Essential Oil Use
Essential oils, distinct from vegetable oils like almond or argan, are another known allergen. Often considered risk-free due to their “natural” label, these products are widely used topically, orally, or via inhalation for various purposes, such as treating respiratory infections or creating relaxing atmospheres. However, essential oils contain fragrant molecules like terpenes, which can become highly allergenic over time, especially after repeated exposure.
Soria emphasized the importance of asking patients about their use of essential oils, especially tea tree and lavender oils, which are commonly used but rarely mentioned by patients unless prompted.
Epoxy Resins in Recreational Use
Epoxy resins are a growing cause of contact allergies, not just in professional settings such as aeronautics and construction work but also increasingly in recreational activities. Soria highlighted the case of a 12-year-old girl hospitalized for severe facial edema after engaging in resin crafts inspired by TikTok. For 6 months, she had been creating resin objects, such as bowls and cutting boards, using vinyl gloves and a Filtering FacePiece 2 mask under adult supervision.
“The growing popularity and online availability of epoxy resins mean that allergic reactions should now be considered even in nonprofessional contexts,” warned Soria.
Clinical Approach
When dermatologists suspect allergic contact dermatitis, the first step is to treat the condition with corticosteroid creams. This is followed by a detailed patient interview to identify suspected allergens in products they’ve used.
Patch testing is then conducted to confirm the allergen. Small chambers containing potential allergens are applied to the upper back for 48 hours without removal. Results are read 2-5 days later, with some cases requiring a 7-day follow-up.
The patient’s occupation is an important factor, as certain professions, such as hairdressing, healthcare, or beauty therapy, are known to trigger allergic contact dermatitis. Similarly, certain hobbies may also play a role.
A thorough approach ensures accurate diagnosis and targeted prevention strategies.
This story was translated from Medscape’s French edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
New allergens responsible for contact dermatitis emerge regularly. During the Dermatology Days of Paris 2024 conference, Angèle Soria, MD, PhD, a dermatologist at Tenon Hospital in Paris, France, outlined four major categories driving this trend. Among them are (meth)acrylates found in nail cosmetics used in salons or do-it-yourself false nail kits that can be bought online.
Isothiazolinones
a preservative used in many cosmetics; (meth)acrylates; essential oils; and epoxy resins used in industry and leisure activities.
Around 15 years ago, parabens, commonly used as preservatives in cosmetics, were identified as endocrine disruptors. In response, they were largely replaced by newer preservatives, notably MI. However, this led to a proliferation of allergic contact dermatitis in Europe between 2010 and 2013.
“About 10% of the population that we tested showed allergies to these preservatives, primarily found in cosmetics,” explained Soria. Since 2015, the use of MI in leave-on cosmetics has been prohibited in Europe and its concentration restricted in rinse-off products. However, cosmetics sold online from outside Europe may not comply with these regulations.
MI is also present in water-based paints to prevent mold. “A few years ago, we started seeing patients with facial angioedema, sometimes combined with asthma, caused by these isothiazolinone preservatives, including in patients who are not professional painters,” said Soria. More recently, attention has shifted to MI’s presence in household cleaning products. A 2020 Spanish study found MI in 76% of 34 analyzed cleaning products.
MI-based fungicides are also used to treat leather during transport, which can lead to contact allergies among professionals and consumers alike. Additionally, MI has been identified in children’s toys, including slime gels, and in florists’ gel cubes used to preserve flowers.
“We are therefore surrounded by these preservatives, which are no longer only in cosmetics,” warned the dermatologist.
(Meth)acrylates
Another major allergen category is (meth)acrylates, responsible for many cases of allergic contact dermatitis. Acrylates and their derivatives are widely used in everyday items. They are low–molecular weight monomers, sensitizing on contact with the skin. Their polymerized forms include materials like Plexiglas.
“We are currently witnessing an epidemic of contact dermatitis in the general population, mainly due to nail cosmetics, such as semipermanent nail polishes and at-home false nail kits,” reported Soria. Nail cosmetics account for 97% of new sensitization cases involving (meth)acrylates. These allergens often cause severe dermatitis, prompting the European Union to mandate labeling in 2020, warning that these products are “for professional use only” and can “cause allergic reactions.”
Beyond nail cosmetics, these allergens are also found in dental products (such as trays), ECG electrodes, prosthetics, glucose sensors, surgical adhesives, and some electronic devices like earbuds and phone screens. Notably, patients sensitized to acrylates via nail kits may experience reactions during dental treatments involving acrylates.
Investigating Essential Oil Use
Essential oils, distinct from vegetable oils like almond or argan, are another known allergen. Often considered risk-free due to their “natural” label, these products are widely used topically, orally, or via inhalation for various purposes, such as treating respiratory infections or creating relaxing atmospheres. However, essential oils contain fragrant molecules like terpenes, which can become highly allergenic over time, especially after repeated exposure.
Soria emphasized the importance of asking patients about their use of essential oils, especially tea tree and lavender oils, which are commonly used but rarely mentioned by patients unless prompted.
Epoxy Resins in Recreational Use
Epoxy resins are a growing cause of contact allergies, not just in professional settings such as aeronautics and construction work but also increasingly in recreational activities. Soria highlighted the case of a 12-year-old girl hospitalized for severe facial edema after engaging in resin crafts inspired by TikTok. For 6 months, she had been creating resin objects, such as bowls and cutting boards, using vinyl gloves and a Filtering FacePiece 2 mask under adult supervision.
“The growing popularity and online availability of epoxy resins mean that allergic reactions should now be considered even in nonprofessional contexts,” warned Soria.
Clinical Approach
When dermatologists suspect allergic contact dermatitis, the first step is to treat the condition with corticosteroid creams. This is followed by a detailed patient interview to identify suspected allergens in products they’ve used.
Patch testing is then conducted to confirm the allergen. Small chambers containing potential allergens are applied to the upper back for 48 hours without removal. Results are read 2-5 days later, with some cases requiring a 7-day follow-up.
The patient’s occupation is an important factor, as certain professions, such as hairdressing, healthcare, or beauty therapy, are known to trigger allergic contact dermatitis. Similarly, certain hobbies may also play a role.
A thorough approach ensures accurate diagnosis and targeted prevention strategies.
This story was translated from Medscape’s French edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Infants Exposed to Minoxidil May Develop Hypertrichosis
OVIEDO, SPAIN – In April 2023, the Navarra Pharmacovigilance Center (NPC) became aware of a case involving an infant who developed progressive hair growth on their back, legs, and thighs (hypertrichosis) over the course of 2 months. During an interview with the family, it was revealed that the infant’s father had been using 5% topical minoxidil to treat androgenic alopecia, and he had taken a leave of absence from work to care for his child. After the medication was discontinued, the infant’s symptoms fully regressed. Specialists from the NPC presented the case at the 13th Spanish Pharmacovigilance Congress in November 2024.
A review of similar cases reported in the Spanish Pharmacovigilance System database identified six additional cases with the same characteristics, all involving infants whose caregivers were using minoxidil. Four more cases were found through the European pharmacovigilance database EudraVigilance and a review of scientific literature, bringing the total to 11 cases.
According to the Navarra Pharmacovigilance Bulletin, these cases are concerning as they highlight the exposure of vulnerable infants to a medication not indicated for their age group. Additionally, the condition can cause significant stress for the families of the affected children.
Mechanism of Transmission Unclear
In the newly identified cases, specialists suspect the drug was transmitted through direct or indirect contact. Accidental ingestion is also a possibility if the infant’s hands touched treated areas on the caregiver’s skin and were then brought to the mouth.
The NPC explained that infants’ skin is more permeable because of the thinner stratum corneum and a higher surface area/body weight ratio, making them more susceptible to absorbing topically applied medications.
Regulatory Changes and Precautions
In light of these findings, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee concluded that, starting in October 2024, product information for medications containing minoxidil should be updated. Specifically, new information must be added to the package insert warning about the risk for hypertrichosis in infants following accidental exposure to minoxidil.
The NPC emphasizes the importance of caregivers being aware of the risks associated with topical medications like minoxidil. Recommended precautions include thoroughly washing hands after applying the product and covering treated areas to prevent direct contact with infants’ skin.
Healthcare professionals should also be aware of this risk and consider it when diagnosing hypertrichosis in infants. Recognizing the connection can prevent unnecessary testing for the infant and alleviate stress for the family.
This story was translated from Univadis Spain using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
OVIEDO, SPAIN – In April 2023, the Navarra Pharmacovigilance Center (NPC) became aware of a case involving an infant who developed progressive hair growth on their back, legs, and thighs (hypertrichosis) over the course of 2 months. During an interview with the family, it was revealed that the infant’s father had been using 5% topical minoxidil to treat androgenic alopecia, and he had taken a leave of absence from work to care for his child. After the medication was discontinued, the infant’s symptoms fully regressed. Specialists from the NPC presented the case at the 13th Spanish Pharmacovigilance Congress in November 2024.
A review of similar cases reported in the Spanish Pharmacovigilance System database identified six additional cases with the same characteristics, all involving infants whose caregivers were using minoxidil. Four more cases were found through the European pharmacovigilance database EudraVigilance and a review of scientific literature, bringing the total to 11 cases.
According to the Navarra Pharmacovigilance Bulletin, these cases are concerning as they highlight the exposure of vulnerable infants to a medication not indicated for their age group. Additionally, the condition can cause significant stress for the families of the affected children.
Mechanism of Transmission Unclear
In the newly identified cases, specialists suspect the drug was transmitted through direct or indirect contact. Accidental ingestion is also a possibility if the infant’s hands touched treated areas on the caregiver’s skin and were then brought to the mouth.
The NPC explained that infants’ skin is more permeable because of the thinner stratum corneum and a higher surface area/body weight ratio, making them more susceptible to absorbing topically applied medications.
Regulatory Changes and Precautions
In light of these findings, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee concluded that, starting in October 2024, product information for medications containing minoxidil should be updated. Specifically, new information must be added to the package insert warning about the risk for hypertrichosis in infants following accidental exposure to minoxidil.
The NPC emphasizes the importance of caregivers being aware of the risks associated with topical medications like minoxidil. Recommended precautions include thoroughly washing hands after applying the product and covering treated areas to prevent direct contact with infants’ skin.
Healthcare professionals should also be aware of this risk and consider it when diagnosing hypertrichosis in infants. Recognizing the connection can prevent unnecessary testing for the infant and alleviate stress for the family.
This story was translated from Univadis Spain using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
OVIEDO, SPAIN – In April 2023, the Navarra Pharmacovigilance Center (NPC) became aware of a case involving an infant who developed progressive hair growth on their back, legs, and thighs (hypertrichosis) over the course of 2 months. During an interview with the family, it was revealed that the infant’s father had been using 5% topical minoxidil to treat androgenic alopecia, and he had taken a leave of absence from work to care for his child. After the medication was discontinued, the infant’s symptoms fully regressed. Specialists from the NPC presented the case at the 13th Spanish Pharmacovigilance Congress in November 2024.
A review of similar cases reported in the Spanish Pharmacovigilance System database identified six additional cases with the same characteristics, all involving infants whose caregivers were using minoxidil. Four more cases were found through the European pharmacovigilance database EudraVigilance and a review of scientific literature, bringing the total to 11 cases.
According to the Navarra Pharmacovigilance Bulletin, these cases are concerning as they highlight the exposure of vulnerable infants to a medication not indicated for their age group. Additionally, the condition can cause significant stress for the families of the affected children.
Mechanism of Transmission Unclear
In the newly identified cases, specialists suspect the drug was transmitted through direct or indirect contact. Accidental ingestion is also a possibility if the infant’s hands touched treated areas on the caregiver’s skin and were then brought to the mouth.
The NPC explained that infants’ skin is more permeable because of the thinner stratum corneum and a higher surface area/body weight ratio, making them more susceptible to absorbing topically applied medications.
Regulatory Changes and Precautions
In light of these findings, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee concluded that, starting in October 2024, product information for medications containing minoxidil should be updated. Specifically, new information must be added to the package insert warning about the risk for hypertrichosis in infants following accidental exposure to minoxidil.
The NPC emphasizes the importance of caregivers being aware of the risks associated with topical medications like minoxidil. Recommended precautions include thoroughly washing hands after applying the product and covering treated areas to prevent direct contact with infants’ skin.
Healthcare professionals should also be aware of this risk and consider it when diagnosing hypertrichosis in infants. Recognizing the connection can prevent unnecessary testing for the infant and alleviate stress for the family.
This story was translated from Univadis Spain using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
FROM THE SPANISH PHARMACOVIGILANCE CONGRESS 2024
Inhaled Insulin Benefits Kids With Diabetes, Too
TOPLINE:
Mannkind expects to submit a request for a supplemental new drug application meeting to the Food and Drug Administration (FDA) for its inhaled human insulin (Afrezza Inhalation Powder). Currently indicated to improve glycemic control in adults with diabetes, the company announced 6-month results from its phase 3 INHALE-1 study of inhaled human insulin in children and adolescents aged 4-17.
METHODOLOGY:
- INHALE-1 is a 26-week, open-label clinical trial that randomized 230 subjects aged 4-17 years with type 1 or type 2 diabetes to either inhaled pre-meal insulin or multiple daily injections (MDI) of rapid-acting insulin analog, both in combination with basal insulin.
- The primary endpoint was a noninferior change in hemoglobin A1c levels, compared with MDI after 26 weeks.
- A 26-week extension phase in which all remaining MDI patients were switched to inhaled insulin is ongoing.
TAKEAWAY:
- In the full intent-to-treat (ITT) population analysis, the between-group difference in mean A1c change over 26 weeks exceeded the prespecified non-inferiority margin of 0.4% (0.435%), but this was largely driven by the variability of a single patient who didn’t adhere to the study protocol.
- A modified ITT analysis excluding that person did not exceed the predetermined threshold of 0.4% (0.370%), thereby establishing noninferiority of inhaled insulin with MDI.
- Over 26 weeks of treatment, there were no differences in lung function parameters between the treatment groups, with mean forced expiratory volume at 1 second (FEV1) at baseline vs 26 weeks of 2.901 liters (99.6% of predicted) vs 2.934 L (96.6%) in the inhaled insulin group and 2.948 L (102.3%) vs 2.957 (98%), respectively, in the MDI group.
- There were no differences between groups or concerns in other safety measures, including hypoglycemia.
IN PRACTICE:
“It was exciting to partner with MannKind and help lead this study to potentially expand the use of inhaled insulin, which is currently used successfully by many adults with diabetes, to a population that hasn’t had a treatment option other than injectable insulin in the history of their care,” said INHALE-1 investigator Roy W. Beck, MD, PhD, founder of the Jaeb Center for Health Research, Tampa, Florida.
“The 6-month results are clinically meaningful and show Afrezza as a potential future treatment option for a growing pediatric population living with type 1 and type 2 diabetes,” Beck added.
SOURCE:
The results of the study were announced at a Mannkind press release on December 16, 2024.
SAFETY INFORMATION:
Inhaled insulin is not recommended for the treatment of diabetic ketoacidosis or in patients who smoke or have recently stopped smoking.
Warning: Risk for acute bronchospasm in patients with chronic lung disease
- Acute bronchospasm has been observed in Afrezza-treated patients with asthma and chronic obstructive pulmonary disease (COPD)
- Afrezza is contraindicated in patients with chronic lung disease such as asthma or COPD
- Before initiating Afrezza, perform a detailed medical history, physical examination, and spirometry (FEV1) to identify potential lung disease in all patients
- Most common adverse reactions are hypoglycemia, cough, and throat pain or irritation.
DISCLOSURES:
This study was funded by MannKind.
A version of this article appeared on Medscape.com.
TOPLINE:
Mannkind expects to submit a request for a supplemental new drug application meeting to the Food and Drug Administration (FDA) for its inhaled human insulin (Afrezza Inhalation Powder). Currently indicated to improve glycemic control in adults with diabetes, the company announced 6-month results from its phase 3 INHALE-1 study of inhaled human insulin in children and adolescents aged 4-17.
METHODOLOGY:
- INHALE-1 is a 26-week, open-label clinical trial that randomized 230 subjects aged 4-17 years with type 1 or type 2 diabetes to either inhaled pre-meal insulin or multiple daily injections (MDI) of rapid-acting insulin analog, both in combination with basal insulin.
- The primary endpoint was a noninferior change in hemoglobin A1c levels, compared with MDI after 26 weeks.
- A 26-week extension phase in which all remaining MDI patients were switched to inhaled insulin is ongoing.
TAKEAWAY:
- In the full intent-to-treat (ITT) population analysis, the between-group difference in mean A1c change over 26 weeks exceeded the prespecified non-inferiority margin of 0.4% (0.435%), but this was largely driven by the variability of a single patient who didn’t adhere to the study protocol.
- A modified ITT analysis excluding that person did not exceed the predetermined threshold of 0.4% (0.370%), thereby establishing noninferiority of inhaled insulin with MDI.
- Over 26 weeks of treatment, there were no differences in lung function parameters between the treatment groups, with mean forced expiratory volume at 1 second (FEV1) at baseline vs 26 weeks of 2.901 liters (99.6% of predicted) vs 2.934 L (96.6%) in the inhaled insulin group and 2.948 L (102.3%) vs 2.957 (98%), respectively, in the MDI group.
- There were no differences between groups or concerns in other safety measures, including hypoglycemia.
IN PRACTICE:
“It was exciting to partner with MannKind and help lead this study to potentially expand the use of inhaled insulin, which is currently used successfully by many adults with diabetes, to a population that hasn’t had a treatment option other than injectable insulin in the history of their care,” said INHALE-1 investigator Roy W. Beck, MD, PhD, founder of the Jaeb Center for Health Research, Tampa, Florida.
“The 6-month results are clinically meaningful and show Afrezza as a potential future treatment option for a growing pediatric population living with type 1 and type 2 diabetes,” Beck added.
SOURCE:
The results of the study were announced at a Mannkind press release on December 16, 2024.
SAFETY INFORMATION:
Inhaled insulin is not recommended for the treatment of diabetic ketoacidosis or in patients who smoke or have recently stopped smoking.
Warning: Risk for acute bronchospasm in patients with chronic lung disease
- Acute bronchospasm has been observed in Afrezza-treated patients with asthma and chronic obstructive pulmonary disease (COPD)
- Afrezza is contraindicated in patients with chronic lung disease such as asthma or COPD
- Before initiating Afrezza, perform a detailed medical history, physical examination, and spirometry (FEV1) to identify potential lung disease in all patients
- Most common adverse reactions are hypoglycemia, cough, and throat pain or irritation.
DISCLOSURES:
This study was funded by MannKind.
A version of this article appeared on Medscape.com.
TOPLINE:
Mannkind expects to submit a request for a supplemental new drug application meeting to the Food and Drug Administration (FDA) for its inhaled human insulin (Afrezza Inhalation Powder). Currently indicated to improve glycemic control in adults with diabetes, the company announced 6-month results from its phase 3 INHALE-1 study of inhaled human insulin in children and adolescents aged 4-17.
METHODOLOGY:
- INHALE-1 is a 26-week, open-label clinical trial that randomized 230 subjects aged 4-17 years with type 1 or type 2 diabetes to either inhaled pre-meal insulin or multiple daily injections (MDI) of rapid-acting insulin analog, both in combination with basal insulin.
- The primary endpoint was a noninferior change in hemoglobin A1c levels, compared with MDI after 26 weeks.
- A 26-week extension phase in which all remaining MDI patients were switched to inhaled insulin is ongoing.
TAKEAWAY:
- In the full intent-to-treat (ITT) population analysis, the between-group difference in mean A1c change over 26 weeks exceeded the prespecified non-inferiority margin of 0.4% (0.435%), but this was largely driven by the variability of a single patient who didn’t adhere to the study protocol.
- A modified ITT analysis excluding that person did not exceed the predetermined threshold of 0.4% (0.370%), thereby establishing noninferiority of inhaled insulin with MDI.
- Over 26 weeks of treatment, there were no differences in lung function parameters between the treatment groups, with mean forced expiratory volume at 1 second (FEV1) at baseline vs 26 weeks of 2.901 liters (99.6% of predicted) vs 2.934 L (96.6%) in the inhaled insulin group and 2.948 L (102.3%) vs 2.957 (98%), respectively, in the MDI group.
- There were no differences between groups or concerns in other safety measures, including hypoglycemia.
IN PRACTICE:
“It was exciting to partner with MannKind and help lead this study to potentially expand the use of inhaled insulin, which is currently used successfully by many adults with diabetes, to a population that hasn’t had a treatment option other than injectable insulin in the history of their care,” said INHALE-1 investigator Roy W. Beck, MD, PhD, founder of the Jaeb Center for Health Research, Tampa, Florida.
“The 6-month results are clinically meaningful and show Afrezza as a potential future treatment option for a growing pediatric population living with type 1 and type 2 diabetes,” Beck added.
SOURCE:
The results of the study were announced at a Mannkind press release on December 16, 2024.
SAFETY INFORMATION:
Inhaled insulin is not recommended for the treatment of diabetic ketoacidosis or in patients who smoke or have recently stopped smoking.
Warning: Risk for acute bronchospasm in patients with chronic lung disease
- Acute bronchospasm has been observed in Afrezza-treated patients with asthma and chronic obstructive pulmonary disease (COPD)
- Afrezza is contraindicated in patients with chronic lung disease such as asthma or COPD
- Before initiating Afrezza, perform a detailed medical history, physical examination, and spirometry (FEV1) to identify potential lung disease in all patients
- Most common adverse reactions are hypoglycemia, cough, and throat pain or irritation.
DISCLOSURES:
This study was funded by MannKind.
A version of this article appeared on Medscape.com.
California Seeks Mental Health Warning Labels on Social Media
In the latest effort to address the mental health crisis among adolescents, legislation in California would require social media platforms to come with a “black box” mental health warning label.
Despite growing evidence linking young people’s use of social media to significant health risks including depression, anxiety, and suicidal thoughts, social media companies have failed to be transparent about the risks, said Assembly member Rebecca Bauer-Kahan (D-Orinda), who introduced Assembly Bill (AB) 56.
“AB 56 ensures that families are armed with clear, actionable information to understand these dangers and make decisions that prioritizes their children’s well-being,” she said in a press release.
Bauer-Kahan noted that 95% of teens report using at least one social media platform and that more than one third say they use social media almost constantly.
“There is a powerful profit motive to keep our young people hooked online and engaged and it is exploiting the human psychology with notifications, likes, endless scrolling, and algorithmic amplification that is harming our children every day,” she said at a press conference on December 9 announcing the bill.
, a sponsor of AB 56, said in a press release.
Speaking at the press conference, Bonta said social media has many “incredible benefits” from giving people an outlet of expression to providing access to critical information but “there is no disputing the fact, it can have an enormously detrimental and dangerous impact on our young people. You cannot debate that. Our children are suffering.”
If AB 56 is successful, he said social media platforms would be required to display a “black box warning” for all users that would appear upon the first use of a platform and weekly thereafter.
The proposed language for the warning label is: “The Surgeon General has advised that there are ample indicators that social media can have a profound risk of harm to the mental health and well-being of children and adolescents.”
“This warning label isn’t a panacea, we know that, but it is another tool in our toolbox. It’s one prong in what has to be a multi-pronged continued, coordinated effort to address this public health crisis,” Bonta said.
Reached for comment, Bonta’s office said sponsorship of the bill was informed by their ongoing work to create a safer online space for children and teens and by the US Surgeon General’s call to Congress to add warning labels to social media.
In June, US Surgeon General Vivek Murthy, MD, said a Surgeon General’s warning label is needed to address the mental health emergency among adolescents and noted that evidence from tobacco studies shows warning labels can increase awareness and change behavior. In September, the attorneys general of 42 states announced their support of the proposal.
Also in September, US Senators John Fetterman (D-PA) and Katie Britt (R-AL) introduced the Stop the Scroll Act to create a mental health warning label requirement for social media platforms.
In a controversial move in November, Australia passed the world’s first law banning social media for children younger than 16 years. The law gives platforms such as TikTok, Facebook, X, Snapchat, and Instagram 1 year to figure out how to implement the ban before facing fines of up 50 million Australian dollars ($33 million) for systemic failures to prevent children younger than 16 years from holding accounts.
‘A Broken Fire Alarm’
“Slapping a warning label on social media is like a broken fire alarm going off with no evidence of smoke. It ignores the reality that most teens view social media as an important outlet for social connection,” Todd O’Boyle, with the tech industry policy group Chamber of Progress, said in a statement on AB 56.
He highlighted a 2022 Pew Research Center survey reporting that most teens credit social media with deepening connections and providing a support network and a 2020 study reporting that social media is not a strong or consistent risk factor for depressive symptoms in US adolescents.
O’Boyle predicted that, without strong evidence, AB 56 will run into the same “First Amendment buzzsaw” that has doomed other California kids’ bills.
Pediatrician Jason Nagata, MD, University of California San Francisco, points out in Bonta’s press release that social media can displace time for other healthful activities including sleep, exercise, and in-person socialization.
“While social media can provide educational content, it can also provide misinformation about health and expose children to content that damages their mental well-being. These are risks that adolescents and their parents should be aware of,” Nagata said.
Indeed, a tearful Victoria Hinks of Larkspur, California, spoke at the press conference of her 16-year-old daughter, Alexandra, who committed suicide 4 months ago after being sucked into social media and served content on self-harm, eating disorders, suicidal ideation, and glamorization of suicide.
“She was led down dark rabbit holes she had no hope of escaping,” Hinks said. “There is not a bone in my body that doubts social media played a role leading her to that final irreversible decision.”
Jim Steyer, CEO and founder of Common Sense Media, applauded California for being the first state to introduce social media warning label legislation. The group plans to lobby for similar proposals in other states he said at the press conference, noting that there are “tens of thousands of Alexandras out there.”
“We have seat belt laws, we have warning labels on cigarettes and alcohol, and that’s what we’re doing here,” Steyer said. “It’s a straightforward simple proposition, which is put your kids and teenagers first, put their self-interest first and hold the largest, most powerful, and wealthy companies in all of our lifetimes accountable for the harms that have happened on their platforms.”
A version of this article first appeared on Medscape.com.
In the latest effort to address the mental health crisis among adolescents, legislation in California would require social media platforms to come with a “black box” mental health warning label.
Despite growing evidence linking young people’s use of social media to significant health risks including depression, anxiety, and suicidal thoughts, social media companies have failed to be transparent about the risks, said Assembly member Rebecca Bauer-Kahan (D-Orinda), who introduced Assembly Bill (AB) 56.
“AB 56 ensures that families are armed with clear, actionable information to understand these dangers and make decisions that prioritizes their children’s well-being,” she said in a press release.
Bauer-Kahan noted that 95% of teens report using at least one social media platform and that more than one third say they use social media almost constantly.
“There is a powerful profit motive to keep our young people hooked online and engaged and it is exploiting the human psychology with notifications, likes, endless scrolling, and algorithmic amplification that is harming our children every day,” she said at a press conference on December 9 announcing the bill.
, a sponsor of AB 56, said in a press release.
Speaking at the press conference, Bonta said social media has many “incredible benefits” from giving people an outlet of expression to providing access to critical information but “there is no disputing the fact, it can have an enormously detrimental and dangerous impact on our young people. You cannot debate that. Our children are suffering.”
If AB 56 is successful, he said social media platforms would be required to display a “black box warning” for all users that would appear upon the first use of a platform and weekly thereafter.
The proposed language for the warning label is: “The Surgeon General has advised that there are ample indicators that social media can have a profound risk of harm to the mental health and well-being of children and adolescents.”
“This warning label isn’t a panacea, we know that, but it is another tool in our toolbox. It’s one prong in what has to be a multi-pronged continued, coordinated effort to address this public health crisis,” Bonta said.
Reached for comment, Bonta’s office said sponsorship of the bill was informed by their ongoing work to create a safer online space for children and teens and by the US Surgeon General’s call to Congress to add warning labels to social media.
In June, US Surgeon General Vivek Murthy, MD, said a Surgeon General’s warning label is needed to address the mental health emergency among adolescents and noted that evidence from tobacco studies shows warning labels can increase awareness and change behavior. In September, the attorneys general of 42 states announced their support of the proposal.
Also in September, US Senators John Fetterman (D-PA) and Katie Britt (R-AL) introduced the Stop the Scroll Act to create a mental health warning label requirement for social media platforms.
In a controversial move in November, Australia passed the world’s first law banning social media for children younger than 16 years. The law gives platforms such as TikTok, Facebook, X, Snapchat, and Instagram 1 year to figure out how to implement the ban before facing fines of up 50 million Australian dollars ($33 million) for systemic failures to prevent children younger than 16 years from holding accounts.
‘A Broken Fire Alarm’
“Slapping a warning label on social media is like a broken fire alarm going off with no evidence of smoke. It ignores the reality that most teens view social media as an important outlet for social connection,” Todd O’Boyle, with the tech industry policy group Chamber of Progress, said in a statement on AB 56.
He highlighted a 2022 Pew Research Center survey reporting that most teens credit social media with deepening connections and providing a support network and a 2020 study reporting that social media is not a strong or consistent risk factor for depressive symptoms in US adolescents.
O’Boyle predicted that, without strong evidence, AB 56 will run into the same “First Amendment buzzsaw” that has doomed other California kids’ bills.
Pediatrician Jason Nagata, MD, University of California San Francisco, points out in Bonta’s press release that social media can displace time for other healthful activities including sleep, exercise, and in-person socialization.
“While social media can provide educational content, it can also provide misinformation about health and expose children to content that damages their mental well-being. These are risks that adolescents and their parents should be aware of,” Nagata said.
Indeed, a tearful Victoria Hinks of Larkspur, California, spoke at the press conference of her 16-year-old daughter, Alexandra, who committed suicide 4 months ago after being sucked into social media and served content on self-harm, eating disorders, suicidal ideation, and glamorization of suicide.
“She was led down dark rabbit holes she had no hope of escaping,” Hinks said. “There is not a bone in my body that doubts social media played a role leading her to that final irreversible decision.”
Jim Steyer, CEO and founder of Common Sense Media, applauded California for being the first state to introduce social media warning label legislation. The group plans to lobby for similar proposals in other states he said at the press conference, noting that there are “tens of thousands of Alexandras out there.”
“We have seat belt laws, we have warning labels on cigarettes and alcohol, and that’s what we’re doing here,” Steyer said. “It’s a straightforward simple proposition, which is put your kids and teenagers first, put their self-interest first and hold the largest, most powerful, and wealthy companies in all of our lifetimes accountable for the harms that have happened on their platforms.”
A version of this article first appeared on Medscape.com.
In the latest effort to address the mental health crisis among adolescents, legislation in California would require social media platforms to come with a “black box” mental health warning label.
Despite growing evidence linking young people’s use of social media to significant health risks including depression, anxiety, and suicidal thoughts, social media companies have failed to be transparent about the risks, said Assembly member Rebecca Bauer-Kahan (D-Orinda), who introduced Assembly Bill (AB) 56.
“AB 56 ensures that families are armed with clear, actionable information to understand these dangers and make decisions that prioritizes their children’s well-being,” she said in a press release.
Bauer-Kahan noted that 95% of teens report using at least one social media platform and that more than one third say they use social media almost constantly.
“There is a powerful profit motive to keep our young people hooked online and engaged and it is exploiting the human psychology with notifications, likes, endless scrolling, and algorithmic amplification that is harming our children every day,” she said at a press conference on December 9 announcing the bill.
, a sponsor of AB 56, said in a press release.
Speaking at the press conference, Bonta said social media has many “incredible benefits” from giving people an outlet of expression to providing access to critical information but “there is no disputing the fact, it can have an enormously detrimental and dangerous impact on our young people. You cannot debate that. Our children are suffering.”
If AB 56 is successful, he said social media platforms would be required to display a “black box warning” for all users that would appear upon the first use of a platform and weekly thereafter.
The proposed language for the warning label is: “The Surgeon General has advised that there are ample indicators that social media can have a profound risk of harm to the mental health and well-being of children and adolescents.”
“This warning label isn’t a panacea, we know that, but it is another tool in our toolbox. It’s one prong in what has to be a multi-pronged continued, coordinated effort to address this public health crisis,” Bonta said.
Reached for comment, Bonta’s office said sponsorship of the bill was informed by their ongoing work to create a safer online space for children and teens and by the US Surgeon General’s call to Congress to add warning labels to social media.
In June, US Surgeon General Vivek Murthy, MD, said a Surgeon General’s warning label is needed to address the mental health emergency among adolescents and noted that evidence from tobacco studies shows warning labels can increase awareness and change behavior. In September, the attorneys general of 42 states announced their support of the proposal.
Also in September, US Senators John Fetterman (D-PA) and Katie Britt (R-AL) introduced the Stop the Scroll Act to create a mental health warning label requirement for social media platforms.
In a controversial move in November, Australia passed the world’s first law banning social media for children younger than 16 years. The law gives platforms such as TikTok, Facebook, X, Snapchat, and Instagram 1 year to figure out how to implement the ban before facing fines of up 50 million Australian dollars ($33 million) for systemic failures to prevent children younger than 16 years from holding accounts.
‘A Broken Fire Alarm’
“Slapping a warning label on social media is like a broken fire alarm going off with no evidence of smoke. It ignores the reality that most teens view social media as an important outlet for social connection,” Todd O’Boyle, with the tech industry policy group Chamber of Progress, said in a statement on AB 56.
He highlighted a 2022 Pew Research Center survey reporting that most teens credit social media with deepening connections and providing a support network and a 2020 study reporting that social media is not a strong or consistent risk factor for depressive symptoms in US adolescents.
O’Boyle predicted that, without strong evidence, AB 56 will run into the same “First Amendment buzzsaw” that has doomed other California kids’ bills.
Pediatrician Jason Nagata, MD, University of California San Francisco, points out in Bonta’s press release that social media can displace time for other healthful activities including sleep, exercise, and in-person socialization.
“While social media can provide educational content, it can also provide misinformation about health and expose children to content that damages their mental well-being. These are risks that adolescents and their parents should be aware of,” Nagata said.
Indeed, a tearful Victoria Hinks of Larkspur, California, spoke at the press conference of her 16-year-old daughter, Alexandra, who committed suicide 4 months ago after being sucked into social media and served content on self-harm, eating disorders, suicidal ideation, and glamorization of suicide.
“She was led down dark rabbit holes she had no hope of escaping,” Hinks said. “There is not a bone in my body that doubts social media played a role leading her to that final irreversible decision.”
Jim Steyer, CEO and founder of Common Sense Media, applauded California for being the first state to introduce social media warning label legislation. The group plans to lobby for similar proposals in other states he said at the press conference, noting that there are “tens of thousands of Alexandras out there.”
“We have seat belt laws, we have warning labels on cigarettes and alcohol, and that’s what we’re doing here,” Steyer said. “It’s a straightforward simple proposition, which is put your kids and teenagers first, put their self-interest first and hold the largest, most powerful, and wealthy companies in all of our lifetimes accountable for the harms that have happened on their platforms.”
A version of this article first appeared on Medscape.com.
Topical Tapinarof Approved for Treating Atopic Dermatitis, Ages 2 and Up
An aryl hydrocarbon receptor agonist, tapinarof cream, 1% was first approved in May 2022 for the topical treatment of plaque psoriasis in adults.
According to a press release from the manufacturer, Organon — which markets tapinarof cream, 1%, under the brand name VTAMA — the new indication for AD is based on results from the ADORING pivotal studies. In ADORING 1, the proportion of patients in the tapinarof cream, 1% treatment group who achieved a score of clear (0) or almost clear (1) and a minimum 2-grade improvement from baseline at week 8 on the Validated Investigator Global Assessment for AD was 45.4%, compared with 13.9% of patients who received vehicle alone. ADORING 2 yielded similar results (46.4% vs 18.0%, respectively; P < .0001 for both associations).
Secondary endpoints measured at week 8 also significantly favored the treatment group over the vehicle group, including the Eczema Area and Severity Index score improvement of at least 75% from baseline and achievement of a ≥ 4-point improvement in the patient-reported Peak Pruritus Numerical Rating Scale from baseline.
The most common adverse reactions (incidence ≥ 1%) were upper respiratory tract infection (12%), folliculitis (9%), lower respiratory tract infection (5%), headache (4%), asthma (2%), vomiting (2%), ear infection (2%), pain in extremity (2%), and abdominal pain (1%), according to the release.
Among 728 patients in the ADORING studies who enrolled in an open-label 48-week extension trial (ADORING 3), 378 entered with or achieved complete disease clearance and discontinued treatment. In this subset of patients, the mean duration of the first treatment-free interval was approximately 80 consecutive days, according to the release.
A version of this article first appeared on Medscape.com.
An aryl hydrocarbon receptor agonist, tapinarof cream, 1% was first approved in May 2022 for the topical treatment of plaque psoriasis in adults.
According to a press release from the manufacturer, Organon — which markets tapinarof cream, 1%, under the brand name VTAMA — the new indication for AD is based on results from the ADORING pivotal studies. In ADORING 1, the proportion of patients in the tapinarof cream, 1% treatment group who achieved a score of clear (0) or almost clear (1) and a minimum 2-grade improvement from baseline at week 8 on the Validated Investigator Global Assessment for AD was 45.4%, compared with 13.9% of patients who received vehicle alone. ADORING 2 yielded similar results (46.4% vs 18.0%, respectively; P < .0001 for both associations).
Secondary endpoints measured at week 8 also significantly favored the treatment group over the vehicle group, including the Eczema Area and Severity Index score improvement of at least 75% from baseline and achievement of a ≥ 4-point improvement in the patient-reported Peak Pruritus Numerical Rating Scale from baseline.
The most common adverse reactions (incidence ≥ 1%) were upper respiratory tract infection (12%), folliculitis (9%), lower respiratory tract infection (5%), headache (4%), asthma (2%), vomiting (2%), ear infection (2%), pain in extremity (2%), and abdominal pain (1%), according to the release.
Among 728 patients in the ADORING studies who enrolled in an open-label 48-week extension trial (ADORING 3), 378 entered with or achieved complete disease clearance and discontinued treatment. In this subset of patients, the mean duration of the first treatment-free interval was approximately 80 consecutive days, according to the release.
A version of this article first appeared on Medscape.com.
An aryl hydrocarbon receptor agonist, tapinarof cream, 1% was first approved in May 2022 for the topical treatment of plaque psoriasis in adults.
According to a press release from the manufacturer, Organon — which markets tapinarof cream, 1%, under the brand name VTAMA — the new indication for AD is based on results from the ADORING pivotal studies. In ADORING 1, the proportion of patients in the tapinarof cream, 1% treatment group who achieved a score of clear (0) or almost clear (1) and a minimum 2-grade improvement from baseline at week 8 on the Validated Investigator Global Assessment for AD was 45.4%, compared with 13.9% of patients who received vehicle alone. ADORING 2 yielded similar results (46.4% vs 18.0%, respectively; P < .0001 for both associations).
Secondary endpoints measured at week 8 also significantly favored the treatment group over the vehicle group, including the Eczema Area and Severity Index score improvement of at least 75% from baseline and achievement of a ≥ 4-point improvement in the patient-reported Peak Pruritus Numerical Rating Scale from baseline.
The most common adverse reactions (incidence ≥ 1%) were upper respiratory tract infection (12%), folliculitis (9%), lower respiratory tract infection (5%), headache (4%), asthma (2%), vomiting (2%), ear infection (2%), pain in extremity (2%), and abdominal pain (1%), according to the release.
Among 728 patients in the ADORING studies who enrolled in an open-label 48-week extension trial (ADORING 3), 378 entered with or achieved complete disease clearance and discontinued treatment. In this subset of patients, the mean duration of the first treatment-free interval was approximately 80 consecutive days, according to the release.
A version of this article first appeared on Medscape.com.
Upfront Therapy for ITP in Children: New Drug a Game-Changer?
“This is the first time in 30 years that a new drug is being tested for newly diagnosed pediatric ITP,” said the study’s lead author, Kristin A. Shimano, MD, professor of pediatrics at the Benioff Children’s Hospital, University of California San Francisco, in a press statement for the study, presented at the American Society of Hematology (ASH) 2024 Annual Meeting earlier this month.
“We really think that this has the potential to transform the approach to the management of ITP in the newly diagnosed phase with the use of a therapy that can provide sustained hemostatic platelet counts to bridge the time that patients are at risk of bleeding events with the goal to wean off the medication for patients who have a natural resolution of their disease,” Shimano said in her talk.
While children with ITP, a rare autoimmune blood disorder, very often improve without the need for any treatment, some do require intervention, and the condition can become chronic. First-line therapies for those patients commonly include corticosteroids, intravenous immunoglobulin (IVIg), and anti-D globulin; however, side effects can be undesirable, and with their efficacy often temporary, patients can require monitoring and juggling of treatments.
Eltrombopag, an oral, daily thrombopoietin receptor agonist, was approved by the US Food and Drug Administration for children and adults with chronic ITP in 2015; however, research has been lacking on the benefits of the therapy for newly diagnosed pediatric patients.
To investigate the drug’s efficacy at that stage, Shimano and colleagues with the ITP Consortium of North America launched the prospective, open-label Pediatric ITP Newly diagnosed pts Epag vs Standard therapy (PINES) trial, enrolling 118 patients at 23 institutions between May 2019 and January 2024.
All enrollees had been diagnosed with ITP within 3 months and had been determined by their treating hematologist to require pharmacologic treatment.
Of the patients, about 40% were untreated, and 60% had been treated with at least one medication prior to the trial but did not have a lasting response.
The patients were stratified by age and prior treatment and randomized 2:1 to receive either eltrombopag (n = 78) or the investigator’s choice of one of three standard first-line therapies, including prednisone, IVIg, or anti-D globulin at specified doses (n = 40). Overall, 29 in the standard-of-care arm received prednisone and 11 received IVIg. The patients had a median age of 8 years.
For the study’s primary endpoint, patients in the eltrombopag group had a significantly greater sustained response at 12 weeks, defined as having at least three of four platelet counts > 50 × 109/L during weeks 6-12 without the need for rescue treatment, with a rate of 63% vs 35% in the standard-of-care group (P = .0054).
There were no significant differences between the two groups in terms of the proportion of patients with a high bleeding score at weeks 1-4 and week 12.
However, those in the eltrombopag arm had a significantly lower rate of receiving rescue therapy (18% vs 38% with the standard of care; P = .02).
Both groups showed clinically meaningful improvements from baseline in terms of health-related quality of life, as assessed by parent proxy-reported KIT overall scores.
Twenty adverse events that were grade 3 or higher, including six serious adverse events, occurred in each of the study’s arms, with the most common events including headache and epistaxis.
Treatment-related serious adverse events occurred among six patients in the eltrombopag group and one in the control group, but importantly, no thromboembolic events were reported.
One intracranial hemorrhage occurred in the eltrombopag arm.
With eltrombopag having a slower effect than some other treatments, Shimano cautioned that the therapy is not recommended for patients with severe bleeding.
“Patients with grade 4 or 5 bleeding at the time of screening were specifically excluded from the study, so for patients who have very severe bleeding who need to get their platelets up very quickly, this would not be the ideal therapy for them,” she noted.
On the basis of results, the trial was recommended to close early due to efficacy; however, the participants are being followed for a total of 12 months to determine the durability of the responses, including in terms of bleeding events, quality of life, or the development of chronic ITP.
“We have shown that in pediatric patients with newly diagnosed ITP requiring pharmacologic treatment, eltrombopag resulted in a significant, clinically relevant higher rate of a durable platelet response in the absence of rescue treatment as compared with standard first-line therapies,” Shimano said.
“Eltrombopag could certainly be added to the medication choices hematologists consider as they are making treatment decisions with families, and it is an option that could potentially raise platelets for a more sustained period in children with ITP in the newly diagnosed period, which is one of the most difficult times for patients with regard to the impact of the disease on bleeding symptoms and quality of life,” she added.
Commenting on the study, James B. Bussel, MD, emeritus professor of pediatrics, medicine and obstetrics and gynecology at Weill Cornell Medicine in New York City, commented that “generally, a short-term increase in platelets is the biggest challenge, which is getting the patient to the point of not requiring future treatment to get better.”
“If more children can be shown to be going into remission earlier, that would be great,” he said.
While eltrombopag is known to be effective in chronic ITP, a key caveat of its use in newly diagnosed patients is the question of whether patients will get better on their own and feasibly be able to be spared the cost and burden of treatment in the first place.
However, identifying which patients will fit that profile isn’t always easy.
“Exactly which child needs treatment can be hard to determine, and there is some debate about that,” Bussel noted.
“The theoretic standard is that the platelet count doesn’t matter — only whether the patient is bleeding a lot, and then there is debate over treatment based on bleeding scores,” he said.
Quality-of-life issues, such as patients’ ability to take part in activities, are also a key consideration.
“It would be great if eltrombopag can support children who really need it and provide clear unequivocal benefit beyond just increasing the platelet count, but also leading to better quality of life,” Bussel said.
The new findings are “a very encouraging start, but I’d really like to see what the story is at 1 year.”
The study was funded by Novartis, maker of eltrombopag, and sponsored by the ITP Consortium of North America. Shimano disclosed ties with Sanofi, Sobi, Daiichi Sankyo, Novartis, and Pfizer. Bussel reported a relationship with Novartis that ended more than 2 years ago.
A version of this article first appeared on Medscape.com.
“This is the first time in 30 years that a new drug is being tested for newly diagnosed pediatric ITP,” said the study’s lead author, Kristin A. Shimano, MD, professor of pediatrics at the Benioff Children’s Hospital, University of California San Francisco, in a press statement for the study, presented at the American Society of Hematology (ASH) 2024 Annual Meeting earlier this month.
“We really think that this has the potential to transform the approach to the management of ITP in the newly diagnosed phase with the use of a therapy that can provide sustained hemostatic platelet counts to bridge the time that patients are at risk of bleeding events with the goal to wean off the medication for patients who have a natural resolution of their disease,” Shimano said in her talk.
While children with ITP, a rare autoimmune blood disorder, very often improve without the need for any treatment, some do require intervention, and the condition can become chronic. First-line therapies for those patients commonly include corticosteroids, intravenous immunoglobulin (IVIg), and anti-D globulin; however, side effects can be undesirable, and with their efficacy often temporary, patients can require monitoring and juggling of treatments.
Eltrombopag, an oral, daily thrombopoietin receptor agonist, was approved by the US Food and Drug Administration for children and adults with chronic ITP in 2015; however, research has been lacking on the benefits of the therapy for newly diagnosed pediatric patients.
To investigate the drug’s efficacy at that stage, Shimano and colleagues with the ITP Consortium of North America launched the prospective, open-label Pediatric ITP Newly diagnosed pts Epag vs Standard therapy (PINES) trial, enrolling 118 patients at 23 institutions between May 2019 and January 2024.
All enrollees had been diagnosed with ITP within 3 months and had been determined by their treating hematologist to require pharmacologic treatment.
Of the patients, about 40% were untreated, and 60% had been treated with at least one medication prior to the trial but did not have a lasting response.
The patients were stratified by age and prior treatment and randomized 2:1 to receive either eltrombopag (n = 78) or the investigator’s choice of one of three standard first-line therapies, including prednisone, IVIg, or anti-D globulin at specified doses (n = 40). Overall, 29 in the standard-of-care arm received prednisone and 11 received IVIg. The patients had a median age of 8 years.
For the study’s primary endpoint, patients in the eltrombopag group had a significantly greater sustained response at 12 weeks, defined as having at least three of four platelet counts > 50 × 109/L during weeks 6-12 without the need for rescue treatment, with a rate of 63% vs 35% in the standard-of-care group (P = .0054).
There were no significant differences between the two groups in terms of the proportion of patients with a high bleeding score at weeks 1-4 and week 12.
However, those in the eltrombopag arm had a significantly lower rate of receiving rescue therapy (18% vs 38% with the standard of care; P = .02).
Both groups showed clinically meaningful improvements from baseline in terms of health-related quality of life, as assessed by parent proxy-reported KIT overall scores.
Twenty adverse events that were grade 3 or higher, including six serious adverse events, occurred in each of the study’s arms, with the most common events including headache and epistaxis.
Treatment-related serious adverse events occurred among six patients in the eltrombopag group and one in the control group, but importantly, no thromboembolic events were reported.
One intracranial hemorrhage occurred in the eltrombopag arm.
With eltrombopag having a slower effect than some other treatments, Shimano cautioned that the therapy is not recommended for patients with severe bleeding.
“Patients with grade 4 or 5 bleeding at the time of screening were specifically excluded from the study, so for patients who have very severe bleeding who need to get their platelets up very quickly, this would not be the ideal therapy for them,” she noted.
On the basis of results, the trial was recommended to close early due to efficacy; however, the participants are being followed for a total of 12 months to determine the durability of the responses, including in terms of bleeding events, quality of life, or the development of chronic ITP.
“We have shown that in pediatric patients with newly diagnosed ITP requiring pharmacologic treatment, eltrombopag resulted in a significant, clinically relevant higher rate of a durable platelet response in the absence of rescue treatment as compared with standard first-line therapies,” Shimano said.
“Eltrombopag could certainly be added to the medication choices hematologists consider as they are making treatment decisions with families, and it is an option that could potentially raise platelets for a more sustained period in children with ITP in the newly diagnosed period, which is one of the most difficult times for patients with regard to the impact of the disease on bleeding symptoms and quality of life,” she added.
Commenting on the study, James B. Bussel, MD, emeritus professor of pediatrics, medicine and obstetrics and gynecology at Weill Cornell Medicine in New York City, commented that “generally, a short-term increase in platelets is the biggest challenge, which is getting the patient to the point of not requiring future treatment to get better.”
“If more children can be shown to be going into remission earlier, that would be great,” he said.
While eltrombopag is known to be effective in chronic ITP, a key caveat of its use in newly diagnosed patients is the question of whether patients will get better on their own and feasibly be able to be spared the cost and burden of treatment in the first place.
However, identifying which patients will fit that profile isn’t always easy.
“Exactly which child needs treatment can be hard to determine, and there is some debate about that,” Bussel noted.
“The theoretic standard is that the platelet count doesn’t matter — only whether the patient is bleeding a lot, and then there is debate over treatment based on bleeding scores,” he said.
Quality-of-life issues, such as patients’ ability to take part in activities, are also a key consideration.
“It would be great if eltrombopag can support children who really need it and provide clear unequivocal benefit beyond just increasing the platelet count, but also leading to better quality of life,” Bussel said.
The new findings are “a very encouraging start, but I’d really like to see what the story is at 1 year.”
The study was funded by Novartis, maker of eltrombopag, and sponsored by the ITP Consortium of North America. Shimano disclosed ties with Sanofi, Sobi, Daiichi Sankyo, Novartis, and Pfizer. Bussel reported a relationship with Novartis that ended more than 2 years ago.
A version of this article first appeared on Medscape.com.
“This is the first time in 30 years that a new drug is being tested for newly diagnosed pediatric ITP,” said the study’s lead author, Kristin A. Shimano, MD, professor of pediatrics at the Benioff Children’s Hospital, University of California San Francisco, in a press statement for the study, presented at the American Society of Hematology (ASH) 2024 Annual Meeting earlier this month.
“We really think that this has the potential to transform the approach to the management of ITP in the newly diagnosed phase with the use of a therapy that can provide sustained hemostatic platelet counts to bridge the time that patients are at risk of bleeding events with the goal to wean off the medication for patients who have a natural resolution of their disease,” Shimano said in her talk.
While children with ITP, a rare autoimmune blood disorder, very often improve without the need for any treatment, some do require intervention, and the condition can become chronic. First-line therapies for those patients commonly include corticosteroids, intravenous immunoglobulin (IVIg), and anti-D globulin; however, side effects can be undesirable, and with their efficacy often temporary, patients can require monitoring and juggling of treatments.
Eltrombopag, an oral, daily thrombopoietin receptor agonist, was approved by the US Food and Drug Administration for children and adults with chronic ITP in 2015; however, research has been lacking on the benefits of the therapy for newly diagnosed pediatric patients.
To investigate the drug’s efficacy at that stage, Shimano and colleagues with the ITP Consortium of North America launched the prospective, open-label Pediatric ITP Newly diagnosed pts Epag vs Standard therapy (PINES) trial, enrolling 118 patients at 23 institutions between May 2019 and January 2024.
All enrollees had been diagnosed with ITP within 3 months and had been determined by their treating hematologist to require pharmacologic treatment.
Of the patients, about 40% were untreated, and 60% had been treated with at least one medication prior to the trial but did not have a lasting response.
The patients were stratified by age and prior treatment and randomized 2:1 to receive either eltrombopag (n = 78) or the investigator’s choice of one of three standard first-line therapies, including prednisone, IVIg, or anti-D globulin at specified doses (n = 40). Overall, 29 in the standard-of-care arm received prednisone and 11 received IVIg. The patients had a median age of 8 years.
For the study’s primary endpoint, patients in the eltrombopag group had a significantly greater sustained response at 12 weeks, defined as having at least three of four platelet counts > 50 × 109/L during weeks 6-12 without the need for rescue treatment, with a rate of 63% vs 35% in the standard-of-care group (P = .0054).
There were no significant differences between the two groups in terms of the proportion of patients with a high bleeding score at weeks 1-4 and week 12.
However, those in the eltrombopag arm had a significantly lower rate of receiving rescue therapy (18% vs 38% with the standard of care; P = .02).
Both groups showed clinically meaningful improvements from baseline in terms of health-related quality of life, as assessed by parent proxy-reported KIT overall scores.
Twenty adverse events that were grade 3 or higher, including six serious adverse events, occurred in each of the study’s arms, with the most common events including headache and epistaxis.
Treatment-related serious adverse events occurred among six patients in the eltrombopag group and one in the control group, but importantly, no thromboembolic events were reported.
One intracranial hemorrhage occurred in the eltrombopag arm.
With eltrombopag having a slower effect than some other treatments, Shimano cautioned that the therapy is not recommended for patients with severe bleeding.
“Patients with grade 4 or 5 bleeding at the time of screening were specifically excluded from the study, so for patients who have very severe bleeding who need to get their platelets up very quickly, this would not be the ideal therapy for them,” she noted.
On the basis of results, the trial was recommended to close early due to efficacy; however, the participants are being followed for a total of 12 months to determine the durability of the responses, including in terms of bleeding events, quality of life, or the development of chronic ITP.
“We have shown that in pediatric patients with newly diagnosed ITP requiring pharmacologic treatment, eltrombopag resulted in a significant, clinically relevant higher rate of a durable platelet response in the absence of rescue treatment as compared with standard first-line therapies,” Shimano said.
“Eltrombopag could certainly be added to the medication choices hematologists consider as they are making treatment decisions with families, and it is an option that could potentially raise platelets for a more sustained period in children with ITP in the newly diagnosed period, which is one of the most difficult times for patients with regard to the impact of the disease on bleeding symptoms and quality of life,” she added.
Commenting on the study, James B. Bussel, MD, emeritus professor of pediatrics, medicine and obstetrics and gynecology at Weill Cornell Medicine in New York City, commented that “generally, a short-term increase in platelets is the biggest challenge, which is getting the patient to the point of not requiring future treatment to get better.”
“If more children can be shown to be going into remission earlier, that would be great,” he said.
While eltrombopag is known to be effective in chronic ITP, a key caveat of its use in newly diagnosed patients is the question of whether patients will get better on their own and feasibly be able to be spared the cost and burden of treatment in the first place.
However, identifying which patients will fit that profile isn’t always easy.
“Exactly which child needs treatment can be hard to determine, and there is some debate about that,” Bussel noted.
“The theoretic standard is that the platelet count doesn’t matter — only whether the patient is bleeding a lot, and then there is debate over treatment based on bleeding scores,” he said.
Quality-of-life issues, such as patients’ ability to take part in activities, are also a key consideration.
“It would be great if eltrombopag can support children who really need it and provide clear unequivocal benefit beyond just increasing the platelet count, but also leading to better quality of life,” Bussel said.
The new findings are “a very encouraging start, but I’d really like to see what the story is at 1 year.”
The study was funded by Novartis, maker of eltrombopag, and sponsored by the ITP Consortium of North America. Shimano disclosed ties with Sanofi, Sobi, Daiichi Sankyo, Novartis, and Pfizer. Bussel reported a relationship with Novartis that ended more than 2 years ago.
A version of this article first appeared on Medscape.com.
FROM ASH 2024
A 16-Year-Old Hispanic Male with a History of Hyperlipidemia Reports a Pruritic Rash on His Neck and Chest
Discussion
Given the patient’s recent dietary changes, particularly his switch to a ketogenic diet, he was diagnosed with prurigo pigmentosa and treated with doxycycline, which cleared the rash. Prurigo pigmentosa is a rare inflammatory dermatosis characterized by net-like or reticulated pink, and later hyperpigmented, papules and plaques. Although the condition predominantly affects young women of East Asian descent, cases have been reported worldwide, highlighting the importance of considering this diagnosis in diverse populations, including children. Here, we describe a case of prurigo pigmentosa in a young male who had recently adopted a ketogenic diet for weight loss.
The association between prurigo pigmentosa and dietary changes, particularly ketosis, is becoming increasingly recognized. This condition is strongly linked to ketosis, a metabolic state marked by the production of ketone bodies (e.g., beta-hydroxybutyrate and acetoacetate) during carbohydrate restriction, fasting, or ketogenic diets, as seen in our patient. These ketone bodies may act as irritants or trigger oxidative stress and inflammatory cascades in the skin.
Ketoacidosis, particularly in prolonged or intense ketosis, is thought to alter the local skin microenvironment, promoting activation of inflammatory cytokines and immune cells. The ketogenic state is believed to generate oxidative stress through increased free fatty acid oxidation, leading to the production of reactive oxygen species (ROS). ROS can induce apoptosis of keratinocytes and inflammation in the epidermis, which is predominantly mediated by neutrophilic infiltration, as seen in histopathological findings. Elevated levels of pro-inflammatory cytokines, such as interleukin-8 (IL-8) and tumor necrosis factor-alpha (TNF-α), have been implicated in neutrophil recruitment and activation. IL-8 is particularly important for guiding neutrophils to areas of injury.
Secondary hyperpigmentation, a hallmark of this condition, is thought to result from melanin-laden macrophages and persistent melanocyte activation in response to inflammation at the dermo-epidermal junction.
The condition progresses in three stages. In the early stage, lesions appear as pruritic, urticarial plaques. These evolve into crusted erythematous papules and papulovesicles in the middle stage, as observed in our patient. Finally, in the late stage, the lesions mature into smooth, hyperpigmented plaques. Each stage of prurigo pigmentosa has distinct histopathological features.
Differential Diagnosis
The differential diagnosis for prurigo pigmentosa includes several conditions that may present similarly. Allergic contact dermatitis (ACD) can initially mimic the erythematous papules of prurigo pigmentosa, but the absence of a clear allergen exposure and failure to improve with avoidance measures makes ACD less likely. Psoriasis is another possibility, as its erythematous plaques may overlap with prurigo pigmentosa. However, the lack of silvery scales and chronicity makes psoriasis less likely in this case. Eczema, or atopic dermatitis, typically presents with pruritic, ill-defined plaques, often in flexural areas, which were not observed in this patient. Flagellate dermatitis, often caused by exposure to bleomycin or consumption of shiitake mushrooms, can present with linear erythematous lesions resembling prurigo pigmentosa. However, the absence of relevant exposures and a flagellate pattern in this patient rules out this diagnosis.
This case highlights the growing recognition of prurigo pigmentosa in the context of dietary trends, especially ketogenic diets, which have become popular for weight loss and other health benefits. Pediatric populations, in particular, may adopt such diets for various reasons and require careful monitoring, as their physiological responses may differ from those in adults. Prurigo pigmentosa has also been reported in a teenager girl with a history of anorexia nervosa, who was in a ketotic state.
Treatment options for prurigo pigmentosa include antibiotics such as minocycline or doxycycline, or macrolides for 4–10 weeks. Other treatment modalities include dapsone, Q-switch Nd:YAG laser, narrow-band ultraviolet B (UVB) phototherapy, and topical treatments like crisaborole and tacrolimus.
Early recognition of this condition is crucial to avoid unnecessary interventions and to allow for resolution through dietary modification. Dermatologists and pediatricians should maintain a high index of suspicion for prurigo pigmentosa in patients presenting with characteristic eruptions and a history of dietary ketosis.
Catalina Matiz is a pediatric dermatologist at Southern California Permanente Medical Group, San Diego.
Suggested Reading
1. Mufti A et al. Clinical Manifestations and Treatment Outcomes in Prurigo Pigmentosa (Nagashima Disease): A Systematic Review of the Literature. JAAD Int. 2021 Apr 10:3:79-87. doi: 10.1016/j.jdin.2021.03.003.
2. Yang J et al. Use of Minocycline for the Treatment of Prurigo Pigmentosa with Intraepidermal Vesiculation: A Case Report. J Int Med Res. 2021 May;49(5):3000605211015593. doi: 10.1177/03000605211015593.
3. Capucilli P et al. Prurigo Pigmentosa: An Itchy, Urticarial Eruption Confused for Food Allergy. J Allergy Clin Immunol Pract. 2018 Jul-Aug;6(4):1381-1382. doi: 10.1016/j.jaip.2018.02.033.
Discussion
Given the patient’s recent dietary changes, particularly his switch to a ketogenic diet, he was diagnosed with prurigo pigmentosa and treated with doxycycline, which cleared the rash. Prurigo pigmentosa is a rare inflammatory dermatosis characterized by net-like or reticulated pink, and later hyperpigmented, papules and plaques. Although the condition predominantly affects young women of East Asian descent, cases have been reported worldwide, highlighting the importance of considering this diagnosis in diverse populations, including children. Here, we describe a case of prurigo pigmentosa in a young male who had recently adopted a ketogenic diet for weight loss.
The association between prurigo pigmentosa and dietary changes, particularly ketosis, is becoming increasingly recognized. This condition is strongly linked to ketosis, a metabolic state marked by the production of ketone bodies (e.g., beta-hydroxybutyrate and acetoacetate) during carbohydrate restriction, fasting, or ketogenic diets, as seen in our patient. These ketone bodies may act as irritants or trigger oxidative stress and inflammatory cascades in the skin.
Ketoacidosis, particularly in prolonged or intense ketosis, is thought to alter the local skin microenvironment, promoting activation of inflammatory cytokines and immune cells. The ketogenic state is believed to generate oxidative stress through increased free fatty acid oxidation, leading to the production of reactive oxygen species (ROS). ROS can induce apoptosis of keratinocytes and inflammation in the epidermis, which is predominantly mediated by neutrophilic infiltration, as seen in histopathological findings. Elevated levels of pro-inflammatory cytokines, such as interleukin-8 (IL-8) and tumor necrosis factor-alpha (TNF-α), have been implicated in neutrophil recruitment and activation. IL-8 is particularly important for guiding neutrophils to areas of injury.
Secondary hyperpigmentation, a hallmark of this condition, is thought to result from melanin-laden macrophages and persistent melanocyte activation in response to inflammation at the dermo-epidermal junction.
The condition progresses in three stages. In the early stage, lesions appear as pruritic, urticarial plaques. These evolve into crusted erythematous papules and papulovesicles in the middle stage, as observed in our patient. Finally, in the late stage, the lesions mature into smooth, hyperpigmented plaques. Each stage of prurigo pigmentosa has distinct histopathological features.
Differential Diagnosis
The differential diagnosis for prurigo pigmentosa includes several conditions that may present similarly. Allergic contact dermatitis (ACD) can initially mimic the erythematous papules of prurigo pigmentosa, but the absence of a clear allergen exposure and failure to improve with avoidance measures makes ACD less likely. Psoriasis is another possibility, as its erythematous plaques may overlap with prurigo pigmentosa. However, the lack of silvery scales and chronicity makes psoriasis less likely in this case. Eczema, or atopic dermatitis, typically presents with pruritic, ill-defined plaques, often in flexural areas, which were not observed in this patient. Flagellate dermatitis, often caused by exposure to bleomycin or consumption of shiitake mushrooms, can present with linear erythematous lesions resembling prurigo pigmentosa. However, the absence of relevant exposures and a flagellate pattern in this patient rules out this diagnosis.
This case highlights the growing recognition of prurigo pigmentosa in the context of dietary trends, especially ketogenic diets, which have become popular for weight loss and other health benefits. Pediatric populations, in particular, may adopt such diets for various reasons and require careful monitoring, as their physiological responses may differ from those in adults. Prurigo pigmentosa has also been reported in a teenager girl with a history of anorexia nervosa, who was in a ketotic state.
Treatment options for prurigo pigmentosa include antibiotics such as minocycline or doxycycline, or macrolides for 4–10 weeks. Other treatment modalities include dapsone, Q-switch Nd:YAG laser, narrow-band ultraviolet B (UVB) phototherapy, and topical treatments like crisaborole and tacrolimus.
Early recognition of this condition is crucial to avoid unnecessary interventions and to allow for resolution through dietary modification. Dermatologists and pediatricians should maintain a high index of suspicion for prurigo pigmentosa in patients presenting with characteristic eruptions and a history of dietary ketosis.
Catalina Matiz is a pediatric dermatologist at Southern California Permanente Medical Group, San Diego.
Suggested Reading
1. Mufti A et al. Clinical Manifestations and Treatment Outcomes in Prurigo Pigmentosa (Nagashima Disease): A Systematic Review of the Literature. JAAD Int. 2021 Apr 10:3:79-87. doi: 10.1016/j.jdin.2021.03.003.
2. Yang J et al. Use of Minocycline for the Treatment of Prurigo Pigmentosa with Intraepidermal Vesiculation: A Case Report. J Int Med Res. 2021 May;49(5):3000605211015593. doi: 10.1177/03000605211015593.
3. Capucilli P et al. Prurigo Pigmentosa: An Itchy, Urticarial Eruption Confused for Food Allergy. J Allergy Clin Immunol Pract. 2018 Jul-Aug;6(4):1381-1382. doi: 10.1016/j.jaip.2018.02.033.
Discussion
Given the patient’s recent dietary changes, particularly his switch to a ketogenic diet, he was diagnosed with prurigo pigmentosa and treated with doxycycline, which cleared the rash. Prurigo pigmentosa is a rare inflammatory dermatosis characterized by net-like or reticulated pink, and later hyperpigmented, papules and plaques. Although the condition predominantly affects young women of East Asian descent, cases have been reported worldwide, highlighting the importance of considering this diagnosis in diverse populations, including children. Here, we describe a case of prurigo pigmentosa in a young male who had recently adopted a ketogenic diet for weight loss.
The association between prurigo pigmentosa and dietary changes, particularly ketosis, is becoming increasingly recognized. This condition is strongly linked to ketosis, a metabolic state marked by the production of ketone bodies (e.g., beta-hydroxybutyrate and acetoacetate) during carbohydrate restriction, fasting, or ketogenic diets, as seen in our patient. These ketone bodies may act as irritants or trigger oxidative stress and inflammatory cascades in the skin.
Ketoacidosis, particularly in prolonged or intense ketosis, is thought to alter the local skin microenvironment, promoting activation of inflammatory cytokines and immune cells. The ketogenic state is believed to generate oxidative stress through increased free fatty acid oxidation, leading to the production of reactive oxygen species (ROS). ROS can induce apoptosis of keratinocytes and inflammation in the epidermis, which is predominantly mediated by neutrophilic infiltration, as seen in histopathological findings. Elevated levels of pro-inflammatory cytokines, such as interleukin-8 (IL-8) and tumor necrosis factor-alpha (TNF-α), have been implicated in neutrophil recruitment and activation. IL-8 is particularly important for guiding neutrophils to areas of injury.
Secondary hyperpigmentation, a hallmark of this condition, is thought to result from melanin-laden macrophages and persistent melanocyte activation in response to inflammation at the dermo-epidermal junction.
The condition progresses in three stages. In the early stage, lesions appear as pruritic, urticarial plaques. These evolve into crusted erythematous papules and papulovesicles in the middle stage, as observed in our patient. Finally, in the late stage, the lesions mature into smooth, hyperpigmented plaques. Each stage of prurigo pigmentosa has distinct histopathological features.
Differential Diagnosis
The differential diagnosis for prurigo pigmentosa includes several conditions that may present similarly. Allergic contact dermatitis (ACD) can initially mimic the erythematous papules of prurigo pigmentosa, but the absence of a clear allergen exposure and failure to improve with avoidance measures makes ACD less likely. Psoriasis is another possibility, as its erythematous plaques may overlap with prurigo pigmentosa. However, the lack of silvery scales and chronicity makes psoriasis less likely in this case. Eczema, or atopic dermatitis, typically presents with pruritic, ill-defined plaques, often in flexural areas, which were not observed in this patient. Flagellate dermatitis, often caused by exposure to bleomycin or consumption of shiitake mushrooms, can present with linear erythematous lesions resembling prurigo pigmentosa. However, the absence of relevant exposures and a flagellate pattern in this patient rules out this diagnosis.
This case highlights the growing recognition of prurigo pigmentosa in the context of dietary trends, especially ketogenic diets, which have become popular for weight loss and other health benefits. Pediatric populations, in particular, may adopt such diets for various reasons and require careful monitoring, as their physiological responses may differ from those in adults. Prurigo pigmentosa has also been reported in a teenager girl with a history of anorexia nervosa, who was in a ketotic state.
Treatment options for prurigo pigmentosa include antibiotics such as minocycline or doxycycline, or macrolides for 4–10 weeks. Other treatment modalities include dapsone, Q-switch Nd:YAG laser, narrow-band ultraviolet B (UVB) phototherapy, and topical treatments like crisaborole and tacrolimus.
Early recognition of this condition is crucial to avoid unnecessary interventions and to allow for resolution through dietary modification. Dermatologists and pediatricians should maintain a high index of suspicion for prurigo pigmentosa in patients presenting with characteristic eruptions and a history of dietary ketosis.
Catalina Matiz is a pediatric dermatologist at Southern California Permanente Medical Group, San Diego.
Suggested Reading
1. Mufti A et al. Clinical Manifestations and Treatment Outcomes in Prurigo Pigmentosa (Nagashima Disease): A Systematic Review of the Literature. JAAD Int. 2021 Apr 10:3:79-87. doi: 10.1016/j.jdin.2021.03.003.
2. Yang J et al. Use of Minocycline for the Treatment of Prurigo Pigmentosa with Intraepidermal Vesiculation: A Case Report. J Int Med Res. 2021 May;49(5):3000605211015593. doi: 10.1177/03000605211015593.
3. Capucilli P et al. Prurigo Pigmentosa: An Itchy, Urticarial Eruption Confused for Food Allergy. J Allergy Clin Immunol Pract. 2018 Jul-Aug;6(4):1381-1382. doi: 10.1016/j.jaip.2018.02.033.
Case Report
A 16-year-old Hispanic male with a history of hyperlipidemia presents to his pediatrician's office for a routine well-child check-up. He reports a pruritic rash on his neck and chest that has been present for the past 1.5 weeks. The rash is itchy, and although a cream from Mexico initially helped, it has not been effective recently. The patient mentions that he has increased his gym workouts and has been training for basketball. He has a history of obesity but has lost almost 100 pounds in the last 6 months. Most recently, he has stopped consuming carbohydrates and has been fasting in the mornings.
There is no history of eczema or psoriasis, either in the patient or his family.
Physical Examination
The patient weighs 147 pounds, a significant decrease from his previous weight of 270 pounds 6 months ago. Other vital signs are within normal limits.
On physical examination, the patient presents with net-like, pink, scaly plaques on his neck, with no other rashes on the body (see Pictures 1 and 2).
Survey Highlights Trends in Pediatric Cosmetic Dermatology Procedures
TOPLINE:
METHODOLOGY:
- An anonymous online survey conducted with SurveyMonkey targeted healthcare providers who routinely used lasers to treat cutaneous conditions in pediatric patients.
- The survey included members of the Society for Pediatric Dermatology and the American Society for Laser Medicine and Surgery and Surgery, as well as fellowship directors and current fellows of the American Society for Dermatologic Surgery.
- A total of 85 practitioners responded to the survey, with 86% answering all questions; respondents primarily included pediatric dermatologists (77.65%), general dermatologists (18.82%), cosmetic dermatologists (8.24%), and dermatologic/Mohs surgeons (1.18%).
TAKEAWAY:
- Hypertrophic or traumatic scars ranked as the most frequently treated pediatric cosmetic condition (95.29%), followed by acne (89.41%), axillary and facial hyperhidrosis (77.65%), hypertrichosis/hirsutism (67.06%), and pigmented lesion removal (64.71%).
- The most common procedures performed were vascular lasers (77.65%), laser hair removal (50.59%), lasers for pigmentation (28.24%), neuromodulators (25.88%), and laser skin resurfacing (22.35%).
- Additional treatments respondents performed included chemical peels (20.00%), radiofrequency microneedling (16.47%), soft tissue fillers (4.71%), and cryolipolysis/body contouring (4.17%).
- About 50% of respondents said they would start cosmetic treatment of acne, and about 66% said they would start laser hair removal treatment between the ages of 12 and 15 years.
IN PRACTICE:
Noting that the survey results provided insight into the types of cosmetic procedures being performed for pediatric patients, the authors wrote, “These interventions can play a significant role in addressing the emotional and social challenges faced by pediatric patients with cosmetic concerns, allowing them to navigate social interactions more confidently and positively.” Before any procedure, they added, “It is important that any comorbid conditions be addressed,” they added, and “ethical considerations regarding informed consent, patient autonomy, and long-term consequences should be carefully weighed, given the vulnerable nature of pediatric patients.”
SOURCE:
The study was led by Lauren Hoffman, MD, who practices dermatology in Great Neck, New York. It was published online in December 2024 in Dermatologic Surgery.
LIMITATIONS:
The study was subjective in nature and had a small sample size, and the exact number of survey recipients was unclear, hindering an accurate calculation of the response rate. The absolute number of responses accounted for a small portion of the total memberships of the participating societies. Also, the data collection periods varied among the three academic societies, and dermatologists’ practice types may have influenced the range and nature of treated conditions.
DISCLOSURES:
The authors did not disclose funding information. They declared no conflicts of interest.
This article was created using several editorial tools, including artificial intelligence, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- An anonymous online survey conducted with SurveyMonkey targeted healthcare providers who routinely used lasers to treat cutaneous conditions in pediatric patients.
- The survey included members of the Society for Pediatric Dermatology and the American Society for Laser Medicine and Surgery and Surgery, as well as fellowship directors and current fellows of the American Society for Dermatologic Surgery.
- A total of 85 practitioners responded to the survey, with 86% answering all questions; respondents primarily included pediatric dermatologists (77.65%), general dermatologists (18.82%), cosmetic dermatologists (8.24%), and dermatologic/Mohs surgeons (1.18%).
TAKEAWAY:
- Hypertrophic or traumatic scars ranked as the most frequently treated pediatric cosmetic condition (95.29%), followed by acne (89.41%), axillary and facial hyperhidrosis (77.65%), hypertrichosis/hirsutism (67.06%), and pigmented lesion removal (64.71%).
- The most common procedures performed were vascular lasers (77.65%), laser hair removal (50.59%), lasers for pigmentation (28.24%), neuromodulators (25.88%), and laser skin resurfacing (22.35%).
- Additional treatments respondents performed included chemical peels (20.00%), radiofrequency microneedling (16.47%), soft tissue fillers (4.71%), and cryolipolysis/body contouring (4.17%).
- About 50% of respondents said they would start cosmetic treatment of acne, and about 66% said they would start laser hair removal treatment between the ages of 12 and 15 years.
IN PRACTICE:
Noting that the survey results provided insight into the types of cosmetic procedures being performed for pediatric patients, the authors wrote, “These interventions can play a significant role in addressing the emotional and social challenges faced by pediatric patients with cosmetic concerns, allowing them to navigate social interactions more confidently and positively.” Before any procedure, they added, “It is important that any comorbid conditions be addressed,” they added, and “ethical considerations regarding informed consent, patient autonomy, and long-term consequences should be carefully weighed, given the vulnerable nature of pediatric patients.”
SOURCE:
The study was led by Lauren Hoffman, MD, who practices dermatology in Great Neck, New York. It was published online in December 2024 in Dermatologic Surgery.
LIMITATIONS:
The study was subjective in nature and had a small sample size, and the exact number of survey recipients was unclear, hindering an accurate calculation of the response rate. The absolute number of responses accounted for a small portion of the total memberships of the participating societies. Also, the data collection periods varied among the three academic societies, and dermatologists’ practice types may have influenced the range and nature of treated conditions.
DISCLOSURES:
The authors did not disclose funding information. They declared no conflicts of interest.
This article was created using several editorial tools, including artificial intelligence, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- An anonymous online survey conducted with SurveyMonkey targeted healthcare providers who routinely used lasers to treat cutaneous conditions in pediatric patients.
- The survey included members of the Society for Pediatric Dermatology and the American Society for Laser Medicine and Surgery and Surgery, as well as fellowship directors and current fellows of the American Society for Dermatologic Surgery.
- A total of 85 practitioners responded to the survey, with 86% answering all questions; respondents primarily included pediatric dermatologists (77.65%), general dermatologists (18.82%), cosmetic dermatologists (8.24%), and dermatologic/Mohs surgeons (1.18%).
TAKEAWAY:
- Hypertrophic or traumatic scars ranked as the most frequently treated pediatric cosmetic condition (95.29%), followed by acne (89.41%), axillary and facial hyperhidrosis (77.65%), hypertrichosis/hirsutism (67.06%), and pigmented lesion removal (64.71%).
- The most common procedures performed were vascular lasers (77.65%), laser hair removal (50.59%), lasers for pigmentation (28.24%), neuromodulators (25.88%), and laser skin resurfacing (22.35%).
- Additional treatments respondents performed included chemical peels (20.00%), radiofrequency microneedling (16.47%), soft tissue fillers (4.71%), and cryolipolysis/body contouring (4.17%).
- About 50% of respondents said they would start cosmetic treatment of acne, and about 66% said they would start laser hair removal treatment between the ages of 12 and 15 years.
IN PRACTICE:
Noting that the survey results provided insight into the types of cosmetic procedures being performed for pediatric patients, the authors wrote, “These interventions can play a significant role in addressing the emotional and social challenges faced by pediatric patients with cosmetic concerns, allowing them to navigate social interactions more confidently and positively.” Before any procedure, they added, “It is important that any comorbid conditions be addressed,” they added, and “ethical considerations regarding informed consent, patient autonomy, and long-term consequences should be carefully weighed, given the vulnerable nature of pediatric patients.”
SOURCE:
The study was led by Lauren Hoffman, MD, who practices dermatology in Great Neck, New York. It was published online in December 2024 in Dermatologic Surgery.
LIMITATIONS:
The study was subjective in nature and had a small sample size, and the exact number of survey recipients was unclear, hindering an accurate calculation of the response rate. The absolute number of responses accounted for a small portion of the total memberships of the participating societies. Also, the data collection periods varied among the three academic societies, and dermatologists’ practice types may have influenced the range and nature of treated conditions.
DISCLOSURES:
The authors did not disclose funding information. They declared no conflicts of interest.
This article was created using several editorial tools, including artificial intelligence, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.