Acne

Spironolactone is an aldosterone antagonist that first was used as a potassium-sparing diuretic to treat heart failure and hypertension. It also possesses antiandrogenic mechanisms including competitively inhibiting androgen receptors, increasing steroid hormone–binding globulin production, and decreasing 5α-reductase activity.¹ These properties have been leveraged in off-label use for dermatologic conditions including acne, hidradenitis suppurativa, androgenic alopecia, and hirsutism.^1,2 Despite being used off-label to treat acne for more than 40 years, spironolactone has not received US Food and Drug Administration approval for this indication.³ Herein, we review the current evidence for use of spironolactone in acne management.

Spironolactone Efficacy

Spironolactone is efficacious for facial and truncal acne in adult females; it cannot be used in males given its anti-androgenic effects.^4,5 In 2 large studies, spironolactone completely or partially cleared facial acne in 75.5% to 85.1% of patients.^4,5 In the first study, which included 395 patients on a median dose of 100 mg/d (range, 25-200 mg/d), clearance of comedonal, papulopustular, and nodulocystic acne was observed.⁴ The second study included 403 patients, most of whom started on spironolactone at 100 mg/d (range, 25-200 mg/d). In addition to facial clearance, patients in this study demonstrated similar rates of partial or complete clearance of acne on the chest (84.0%) and back (80.2%) assessed via a comprehensive acne severity scale.⁵ In both studies, doses of 100 mg/d or higher were most effective, and the median time to initial acne improvement was 3 months, with peak effects occurring after 4 to 6 months of treatment.^4,5 Most patients were using spironolactone monotherapy or spironolactone in combination with topical therapies; however, a minority used it concurrently with oral antibiotics and/or combined oral contraceptives.

Spironolactone has demonstrated comparable efficacy to tetracycline antibiotics. A study comparing the rate of switching to another systemic therapy within 1 year of treatment initiation identified similar rates in patients started on spironolactone (n=962) and those started on tetracyclines (n=4236)(14.4% vs 13.4%, respectively). As switching may indicate treatment failure due to insufficient efficacy, adverse effects, or other causes, these findings may suggest similar effectiveness for spironolactone and tetracyclines.⁶ These treatments also were compared in a randomized controlled trial of 133 patients receiving topical benzoyl peroxide 5% for 6 months and either spironolactone 150 mg/d for 6 months or doxycycline 100 mg/d for 3 months followed by oral placebo for 3 months. At 4 months, spironolactone performed better than doxycycline as assessed using the Adult Female Acne Scoring Tool.³ Although doxycycline was stopped after 3 months and only topical therapy was continued, this finding is notable because guidelines from the American Academy of Dermatology recommend limiting tetracycline use to 3 to 4 months, whereas spironolactone may be continued for prolonged durations.^1,4

While most studies have evaluated the efficacy of spironolactone in adult females, it is increasingly being prescribed in adolescents.⁷ In a study that included 80 females aged 14 to 20 years, 80% (64/80) experienced acne improvement on a median dose of 100 mg/d.⁸ Additionally, in the study evaluating treatment switching rates, more than 80% of 1139 adolescents who were started on spironolactone were not switched to a different systemic therapy within the first year of treatment, demonstrating the efficacy of spironolactone in this demographic.⁶ However, treatment switching was more common among adolescents started on spironolactone compared with those who started on tetracyclines. As noted for adults, the treatment switching rates were the same for spironolactone and tetracycline users; the difference in adolescents may be due to lower influence of hormonal factors or higher therapeutic expectations in this population.⁶

Spironolactone Safety

Spironolactone is well tolerated at doses of 25 to 200 mg/d for acne management. Common adverse effects include diuresis (29% [26/90]), menstrual irregularities (22% [20/90]), fatigue (17% [15/90]), headache (14% [13/90]), and dizziness (12% [11/90]), but they infrequently lead to treatment discontinuation.^4,9 Rates of adverse effects are lower in adolescents compared to adults, although the effects of spironolactone on early endocrine development in adolescents are unknown.⁷ Spironolactone should not be used during pregnancy, and concurrent contraception use is advised because spironolactone has caused feminization of male fetuses in animal studies.^1,10-11

While concerns about potentially severe adverse effects including hypotension, hyperkalemia, and tumorigenicity have been raised, their occurrence in the literature is rare.^5,12-18 In a study evaluating hypotension in 2084 patients taking spironolactone 50 to 200 mg/day for acne, hair loss, and/or hirsutism, 3.1% experienced absolute hypotension, and only 0.26% required dose reduction or discontinuation.¹² Another study of 403 patients taking spironolactone for acne reported a statistically significant but clinically insignificant mean reduction in systolic blood pressure of 3.5 mm Hg.⁵ While clinically relevant hypotension is unlikely to occur, some authors still recommend measuring baseline blood pressure before spironolactone initiation.¹²

Many large studies have demonstrated that hyperkalemia with spironolactone use is rare in young healthy women.^13-15 In one study of patients aged 18 to 45 years treated with spironolactone for acne, only 0.72% of 1802 serum potassium measurements fell within the range of mild hyperkalemia.¹³ Another study found a significantly greater incidence of hyperkalemia in healthy women aged 46 to 65 years compared with women younger than 45 years (16.7% vs <1%; P=.0245).¹⁴ Additionally, among 27 patients taking spironolactone and oral contraceptives containing drospirenone (a spironolactone analog), none had elevated potassium levels.¹⁵ Given these findings, American Academy of Dermatology guidelines suggest that monitoring potassium in young healthy women has low utility but should be considered in those with risk factors including older age; renal and cardiovascular disease; and concurrent medications that interfere with renal, adrenal, and hepatic function.¹ If performed, monitoring should be done within the first few weeks of initiating spironolactone for early detection of hyperkalemia.¹⁶

Spironolactone has a US Food and Drug Administration warning for tumorigenicity based on studies in rats that were given up to 150 times the amount for human therapeutic doses and subsequently developed thyroid, hepatic, testicular, and breast adenomas.¹ However, several large studies in humans have not found an association between spironolactone and breast cancer (BC) development.^1,17,18 Furthermore, a large retrospective study found no increased risk for recurrence in BC survivors treated with spironolactone.² Most carcinogenicity studies include older women, which may limit generalizability of the findings to younger women, who comprise the majority of patients being treated for acne. Recently, however, a retrospective study evaluating healthy females aged 9 to 40 years with acne identified no significant increased risk for BC in patients treated with spironolactone.¹⁷ When compared to tetracyclines, there was a slightly decreased BC risk with spironolactone, providing further support for the latter’s safety. Finally, a large systematic review identified no association between spironolactone and ovarian, bladder, kidney, gastric, or esophageal cancers.¹⁸

Final Thoughts

Over the past several years, an ever-expanding body of literature supporting the efficacy and safety of spironolactone has emerged. While spironolactone has been used off label for decades to treat acne in healthy adult females, there are now strong data to support its efficacy in adolescent females. Notably, spironolactone consistently demonstrates similar effectiveness to first-line tetracycline antibiotics. Additionally, data suggest that spironolactone is safe in patients with a history of BC. Overall, spironolactone is a safe, comparable, and promising alternative to antibiotics for acne management in adult and adolescent females.

Spironolactone is an aldosterone antagonist that first was used as a potassium-sparing diuretic to treat heart failure and hypertension. It also possesses antiandrogenic mechanisms including competitively inhibiting androgen receptors, increasing steroid hormone–binding globulin production, and decreasing 5α-reductase activity.¹ These properties have been leveraged in off-label use for dermatologic conditions including acne, hidradenitis suppurativa, androgenic alopecia, and hirsutism.^1,2 Despite being used off-label to treat acne for more than 40 years, spironolactone has not received US Food and Drug Administration approval for this indication.³ Herein, we review the current evidence for use of spironolactone in acne management.

Spironolactone Efficacy

Spironolactone is efficacious for facial and truncal acne in adult females; it cannot be used in males given its anti-androgenic effects.^4,5 In 2 large studies, spironolactone completely or partially cleared facial acne in 75.5% to 85.1% of patients.^4,5 In the first study, which included 395 patients on a median dose of 100 mg/d (range, 25-200 mg/d), clearance of comedonal, papulopustular, and nodulocystic acne was observed.⁴ The second study included 403 patients, most of whom started on spironolactone at 100 mg/d (range, 25-200 mg/d). In addition to facial clearance, patients in this study demonstrated similar rates of partial or complete clearance of acne on the chest (84.0%) and back (80.2%) assessed via a comprehensive acne severity scale.⁵ In both studies, doses of 100 mg/d or higher were most effective, and the median time to initial acne improvement was 3 months, with peak effects occurring after 4 to 6 months of treatment.^4,5 Most patients were using spironolactone monotherapy or spironolactone in combination with topical therapies; however, a minority used it concurrently with oral antibiotics and/or combined oral contraceptives.

Spironolactone has demonstrated comparable efficacy to tetracycline antibiotics. A study comparing the rate of switching to another systemic therapy within 1 year of treatment initiation identified similar rates in patients started on spironolactone (n=962) and those started on tetracyclines (n=4236)(14.4% vs 13.4%, respectively). As switching may indicate treatment failure due to insufficient efficacy, adverse effects, or other causes, these findings may suggest similar effectiveness for spironolactone and tetracyclines.⁶ These treatments also were compared in a randomized controlled trial of 133 patients receiving topical benzoyl peroxide 5% for 6 months and either spironolactone 150 mg/d for 6 months or doxycycline 100 mg/d for 3 months followed by oral placebo for 3 months. At 4 months, spironolactone performed better than doxycycline as assessed using the Adult Female Acne Scoring Tool.³ Although doxycycline was stopped after 3 months and only topical therapy was continued, this finding is notable because guidelines from the American Academy of Dermatology recommend limiting tetracycline use to 3 to 4 months, whereas spironolactone may be continued for prolonged durations.^1,4

While most studies have evaluated the efficacy of spironolactone in adult females, it is increasingly being prescribed in adolescents.⁷ In a study that included 80 females aged 14 to 20 years, 80% (64/80) experienced acne improvement on a median dose of 100 mg/d.⁸ Additionally, in the study evaluating treatment switching rates, more than 80% of 1139 adolescents who were started on spironolactone were not switched to a different systemic therapy within the first year of treatment, demonstrating the efficacy of spironolactone in this demographic.⁶ However, treatment switching was more common among adolescents started on spironolactone compared with those who started on tetracyclines. As noted for adults, the treatment switching rates were the same for spironolactone and tetracycline users; the difference in adolescents may be due to lower influence of hormonal factors or higher therapeutic expectations in this population.⁶

Spironolactone Safety

Spironolactone is well tolerated at doses of 25 to 200 mg/d for acne management. Common adverse effects include diuresis (29% [26/90]), menstrual irregularities (22% [20/90]), fatigue (17% [15/90]), headache (14% [13/90]), and dizziness (12% [11/90]), but they infrequently lead to treatment discontinuation.^4,9 Rates of adverse effects are lower in adolescents compared to adults, although the effects of spironolactone on early endocrine development in adolescents are unknown.⁷ Spironolactone should not be used during pregnancy, and concurrent contraception use is advised because spironolactone has caused feminization of male fetuses in animal studies.^1,10-11

While concerns about potentially severe adverse effects including hypotension, hyperkalemia, and tumorigenicity have been raised, their occurrence in the literature is rare.^5,12-18 In a study evaluating hypotension in 2084 patients taking spironolactone 50 to 200 mg/day for acne, hair loss, and/or hirsutism, 3.1% experienced absolute hypotension, and only 0.26% required dose reduction or discontinuation.¹² Another study of 403 patients taking spironolactone for acne reported a statistically significant but clinically insignificant mean reduction in systolic blood pressure of 3.5 mm Hg.⁵ While clinically relevant hypotension is unlikely to occur, some authors still recommend measuring baseline blood pressure before spironolactone initiation.¹²

Many large studies have demonstrated that hyperkalemia with spironolactone use is rare in young healthy women.^13-15 In one study of patients aged 18 to 45 years treated with spironolactone for acne, only 0.72% of 1802 serum potassium measurements fell within the range of mild hyperkalemia.¹³ Another study found a significantly greater incidence of hyperkalemia in healthy women aged 46 to 65 years compared with women younger than 45 years (16.7% vs <1%; P=.0245).¹⁴ Additionally, among 27 patients taking spironolactone and oral contraceptives containing drospirenone (a spironolactone analog), none had elevated potassium levels.¹⁵ Given these findings, American Academy of Dermatology guidelines suggest that monitoring potassium in young healthy women has low utility but should be considered in those with risk factors including older age; renal and cardiovascular disease; and concurrent medications that interfere with renal, adrenal, and hepatic function.¹ If performed, monitoring should be done within the first few weeks of initiating spironolactone for early detection of hyperkalemia.¹⁶

Spironolactone has a US Food and Drug Administration warning for tumorigenicity based on studies in rats that were given up to 150 times the amount for human therapeutic doses and subsequently developed thyroid, hepatic, testicular, and breast adenomas.¹ However, several large studies in humans have not found an association between spironolactone and breast cancer (BC) development.^1,17,18 Furthermore, a large retrospective study found no increased risk for recurrence in BC survivors treated with spironolactone.² Most carcinogenicity studies include older women, which may limit generalizability of the findings to younger women, who comprise the majority of patients being treated for acne. Recently, however, a retrospective study evaluating healthy females aged 9 to 40 years with acne identified no significant increased risk for BC in patients treated with spironolactone.¹⁷ When compared to tetracyclines, there was a slightly decreased BC risk with spironolactone, providing further support for the latter’s safety. Finally, a large systematic review identified no association between spironolactone and ovarian, bladder, kidney, gastric, or esophageal cancers.¹⁸

Final Thoughts

Over the past several years, an ever-expanding body of literature supporting the efficacy and safety of spironolactone has emerged. While spironolactone has been used off label for decades to treat acne in healthy adult females, there are now strong data to support its efficacy in adolescent females. Notably, spironolactone consistently demonstrates similar effectiveness to first-line tetracycline antibiotics. Additionally, data suggest that spironolactone is safe in patients with a history of BC. Overall, spironolactone is a safe, comparable, and promising alternative to antibiotics for acne management in adult and adolescent females.

Spironolactone is an aldosterone antagonist that first was used as a potassium-sparing diuretic to treat heart failure and hypertension. It also possesses antiandrogenic mechanisms including competitively inhibiting androgen receptors, increasing steroid hormone–binding globulin production, and decreasing 5α-reductase activity.¹ These properties have been leveraged in off-label use for dermatologic conditions including acne, hidradenitis suppurativa, androgenic alopecia, and hirsutism.^1,2 Despite being used off-label to treat acne for more than 40 years, spironolactone has not received US Food and Drug Administration approval for this indication.³ Herein, we review the current evidence for use of spironolactone in acne management.

Spironolactone Efficacy

Spironolactone is efficacious for facial and truncal acne in adult females; it cannot be used in males given its anti-androgenic effects.^4,5 In 2 large studies, spironolactone completely or partially cleared facial acne in 75.5% to 85.1% of patients.^4,5 In the first study, which included 395 patients on a median dose of 100 mg/d (range, 25-200 mg/d), clearance of comedonal, papulopustular, and nodulocystic acne was observed.⁴ The second study included 403 patients, most of whom started on spironolactone at 100 mg/d (range, 25-200 mg/d). In addition to facial clearance, patients in this study demonstrated similar rates of partial or complete clearance of acne on the chest (84.0%) and back (80.2%) assessed via a comprehensive acne severity scale.⁵ In both studies, doses of 100 mg/d or higher were most effective, and the median time to initial acne improvement was 3 months, with peak effects occurring after 4 to 6 months of treatment.^4,5 Most patients were using spironolactone monotherapy or spironolactone in combination with topical therapies; however, a minority used it concurrently with oral antibiotics and/or combined oral contraceptives.

Spironolactone has demonstrated comparable efficacy to tetracycline antibiotics. A study comparing the rate of switching to another systemic therapy within 1 year of treatment initiation identified similar rates in patients started on spironolactone (n=962) and those started on tetracyclines (n=4236)(14.4% vs 13.4%, respectively). As switching may indicate treatment failure due to insufficient efficacy, adverse effects, or other causes, these findings may suggest similar effectiveness for spironolactone and tetracyclines.⁶ These treatments also were compared in a randomized controlled trial of 133 patients receiving topical benzoyl peroxide 5% for 6 months and either spironolactone 150 mg/d for 6 months or doxycycline 100 mg/d for 3 months followed by oral placebo for 3 months. At 4 months, spironolactone performed better than doxycycline as assessed using the Adult Female Acne Scoring Tool.³ Although doxycycline was stopped after 3 months and only topical therapy was continued, this finding is notable because guidelines from the American Academy of Dermatology recommend limiting tetracycline use to 3 to 4 months, whereas spironolactone may be continued for prolonged durations.^1,4

While most studies have evaluated the efficacy of spironolactone in adult females, it is increasingly being prescribed in adolescents.⁷ In a study that included 80 females aged 14 to 20 years, 80% (64/80) experienced acne improvement on a median dose of 100 mg/d.⁸ Additionally, in the study evaluating treatment switching rates, more than 80% of 1139 adolescents who were started on spironolactone were not switched to a different systemic therapy within the first year of treatment, demonstrating the efficacy of spironolactone in this demographic.⁶ However, treatment switching was more common among adolescents started on spironolactone compared with those who started on tetracyclines. As noted for adults, the treatment switching rates were the same for spironolactone and tetracycline users; the difference in adolescents may be due to lower influence of hormonal factors or higher therapeutic expectations in this population.⁶

Spironolactone Safety

Spironolactone is well tolerated at doses of 25 to 200 mg/d for acne management. Common adverse effects include diuresis (29% [26/90]), menstrual irregularities (22% [20/90]), fatigue (17% [15/90]), headache (14% [13/90]), and dizziness (12% [11/90]), but they infrequently lead to treatment discontinuation.^4,9 Rates of adverse effects are lower in adolescents compared to adults, although the effects of spironolactone on early endocrine development in adolescents are unknown.⁷ Spironolactone should not be used during pregnancy, and concurrent contraception use is advised because spironolactone has caused feminization of male fetuses in animal studies.^1,10-11

While concerns about potentially severe adverse effects including hypotension, hyperkalemia, and tumorigenicity have been raised, their occurrence in the literature is rare.^5,12-18 In a study evaluating hypotension in 2084 patients taking spironolactone 50 to 200 mg/day for acne, hair loss, and/or hirsutism, 3.1% experienced absolute hypotension, and only 0.26% required dose reduction or discontinuation.¹² Another study of 403 patients taking spironolactone for acne reported a statistically significant but clinically insignificant mean reduction in systolic blood pressure of 3.5 mm Hg.⁵ While clinically relevant hypotension is unlikely to occur, some authors still recommend measuring baseline blood pressure before spironolactone initiation.¹²

Many large studies have demonstrated that hyperkalemia with spironolactone use is rare in young healthy women.^13-15 In one study of patients aged 18 to 45 years treated with spironolactone for acne, only 0.72% of 1802 serum potassium measurements fell within the range of mild hyperkalemia.¹³ Another study found a significantly greater incidence of hyperkalemia in healthy women aged 46 to 65 years compared with women younger than 45 years (16.7% vs <1%; P=.0245).¹⁴ Additionally, among 27 patients taking spironolactone and oral contraceptives containing drospirenone (a spironolactone analog), none had elevated potassium levels.¹⁵ Given these findings, American Academy of Dermatology guidelines suggest that monitoring potassium in young healthy women has low utility but should be considered in those with risk factors including older age; renal and cardiovascular disease; and concurrent medications that interfere with renal, adrenal, and hepatic function.¹ If performed, monitoring should be done within the first few weeks of initiating spironolactone for early detection of hyperkalemia.¹⁶

Spironolactone has a US Food and Drug Administration warning for tumorigenicity based on studies in rats that were given up to 150 times the amount for human therapeutic doses and subsequently developed thyroid, hepatic, testicular, and breast adenomas.¹ However, several large studies in humans have not found an association between spironolactone and breast cancer (BC) development.^1,17,18 Furthermore, a large retrospective study found no increased risk for recurrence in BC survivors treated with spironolactone.² Most carcinogenicity studies include older women, which may limit generalizability of the findings to younger women, who comprise the majority of patients being treated for acne. Recently, however, a retrospective study evaluating healthy females aged 9 to 40 years with acne identified no significant increased risk for BC in patients treated with spironolactone.¹⁷ When compared to tetracyclines, there was a slightly decreased BC risk with spironolactone, providing further support for the latter’s safety. Finally, a large systematic review identified no association between spironolactone and ovarian, bladder, kidney, gastric, or esophageal cancers.¹⁸

Final Thoughts

Over the past several years, an ever-expanding body of literature supporting the efficacy and safety of spironolactone has emerged. While spironolactone has been used off label for decades to treat acne in healthy adult females, there are now strong data to support its efficacy in adolescent females. Notably, spironolactone consistently demonstrates similar effectiveness to first-line tetracycline antibiotics. Additionally, data suggest that spironolactone is safe in patients with a history of BC. Overall, spironolactone is a safe, comparable, and promising alternative to antibiotics for acne management in adult and adolescent females.

Outrageous assertions with little evidence are not new. Even the famous statement “There’s a sucker born every minute,” long attributed to 1800s showman P.T. Barnum, lacks evidence that the circus founder uttered the remark. The message itself and the snippet of a story about the message may be pertinent, though, when we consider the touted benefits of Bacillus lysate for the skin. The focus of this column will be the foundation for the use of probiotics and prebiotics in skin care and then claims made about this skin care ingredient derived from a particular strain of Bacillus bacteria.

The benefits of prebiotics and probiotics to human health, and skin health in particular, have been investigated with increasing frequency in the last 20 years. Typically, this topic is broached in the context of the gut-skin axis and the skin and gut microbiomes.^1-3 In 2014, Miyazaki et al. found that phenols produced by gut bacteria spurred skin disorders and that decreasing phenols with probiotics and/or prebiotics can restore or maintain cutaneous health.⁴

Probiotics have been associated with antioxidant activity, primarily because of the presence of antioxidant enzymes (eg, superoxide dismutase), the delivery of antioxidant substances (eg, glutathione), and extracellular polysaccharide synthesis.^5-8 Further, probiotics are known to synthesize a cascade of substances with anti-inflammatory, antibacterial, immunomodulatory, and angiogenetic functions that can contribute to wound healing.⁹ The use of probiotics in skin health largely relies on applying inactivated beneficial bacteria.¹⁰ Prebiotics, which are non-digestible plant-based carbohydrates that aid digestion, inhibit pathogens, and support beneficial bacteria, are known to rebalance the skin microflora.¹⁰ In addition, prebiotics are considered a robust option to replace live bacteria in skin formulations.¹¹ Bacterial cell lysates, which include bacterial metabolites, cell walls, and dead bacteria, are incorporated into skin care products as well.¹²

Probiotics and Wound Healing

In 2020, Ashoori et al. reported on their study of three formulations composed of probiotic supernatant (Lactobacillus reuteri, L. fermentum, and Bacillus subtilis sp. natto)-loaded chitosan nanogels prepared from cultures. They evaluated the effectiveness and dressing activity of the formulations by gauging wound closure and histological results in Sprague-Dawley rats. The researchers found that all probiotic lysate preparations conferred healing properties, with the Bacillus subtilis natto yielding the best wound healing quality. They concluded that probiotic lysate nanogels impart a range of benefits, such as favorable wound closure rates, improved appearance, and suitable histological results upon in vivo examination, supporting the potential use of such formulations to treat wounds.⁹

Probiotics and Treating Skin Disorders

A 2015 review by Roudsari et al. suggests that probiotics display the potential for preventing and treating various skin disorders, including acne, atopic dermatitis, allergic inflammation or hypersensitivity, eczema, photodamage, and wounds.⁸ They reported that in a US patent, Gueniche revealed ways to employ at least one probiotic microorganism (from Lactobacillus and/or Bifidobacterium) as an active agent to prevent or treat skin irritation.^8,13 In addition, they noted that L. brevis was used successfully by DeSimone in 2003 to promote apoptosis and/or diminish inflammation, particularly in creams and ointments to alleviate inflammation.8

At around the same time, Miyazaki et al. reported that Bifidobacterium-fermented soy milk extract stimulated the production of hyaluronic acid (HA) in organotypic cultures of human keratinocytes, cultures of human skin fibroblasts, and hairless mouse skin after 2 weeks of topical application and has the potential to promote HA synthesis in the epidermis and dermis and thus act as an anti-aging agent.¹⁴ In another study, Miyazaki et al. investigated the impact of Bifidobacterium-fermented soy milk extract containing genistein and daidzein on the HA content of hairless mouse as well as human skin. After 6 weeks of topical application in mice, skin elasticity, viscoelasticity, hydration, and thickness improved, and HA content increased. In addition, after 3 months of topical application of a 10% Bifidobacterium-fermented soy milk extract gel to the human forearm, decreases in skin elasticity were significantly mitigated.¹⁵More recently, in 2023, Xie et al. reviewed clinical and experimental data on the use of various species of Lactobacillus for the treatment and prevention of atopic dermatitis (AD). They found evidence that multiple species (L. rhamnosus in animal and clinical experiments) appeared to be effective in preventing and treating AD, with L. acidophilus lessening symptoms and reported to be safe, L. plantarum improving symptoms through immunomodulatory activity, and L. sakei demonstrating anti-inflammatory and skin barrier protective activity. The authors also noted that L. paracasei exhibited anti-inflammatory effects on AD-like skin lesions, and L. reuteri supplementation prevented AD development. Overall, they called for more in vivo studies and randomized controlled clinical trials to fully elucidate the wide-ranging potential of Lactobacillus species in treating and preventing AD.¹⁶

The Darker Side of Using Prebiotic Species in Skin Care?

According to manufacturer Delavie Sciences, its Aeonia product line was based on research conducted on the International Space Station, which allowed for its patented microorganism to be exposed to the conditions of outer space. This cornerstone ingredient, Bacillus lysate, once returned to Earth, reportedly exhibited anti-aging and UV-protective characteristics. The product line has been described as a prebiotic that contributes to a healthy skin barrier.¹⁷

In a September 2023 interview in CosmeticsDesign, the president of Delavie Sciences clarified that its Bacillus lysate contains no live bacteria and that it is not a probiotic, but rather, the certified prebiotic lysate is a Bacillus extract that has been used to strengthen the SPF potency of skin care formulations.¹⁸ Because of the research performed on the International Space Station, the manufacturers are claiming these ingredients could be “out-of-this-world” as a way to promote results that have, as yet, not been verified by peer review. 

 

Conclusion

Probiotics and prebiotics continue to be the focus of multiple lines of research for their applications and further potential in skin care. In the case of the Bacillus lysate prebiotic compound, there is a kernel of an interesting idea here, at the very least. But proprietary research limits our ability to render a comprehensive evaluation at this time. Such bold and outrageous claims spur more skepticism than optimism. However, lysates are the latest thing in skin care — so we need to keep watch on the developments to stay current. But that’s what you have me for, I’ll help keep you current on new ingredient findings. If you are on LinkedIn, come connect with me. I post breaking ingredient news and skin care trends there to help you answer patient questions. When you are asked if these lysates work, the answer is: All the data we have on bacillus extract are from computer analysis of the ingredient properties and not on the actual formulations or products. Stay tuned.

Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur in Miami. She founded the division of cosmetic dermatology at the University of Miami in 1997. The third edition of her bestselling textbook, “Cosmetic Dermatology,” was published in 2022. Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Galderma, Johnson & Johnson, and Burt’s Bees. She is the CEO of Skin Type Solutions Inc., a SaaS company used to generate skin care routines in office and as a ecommerce solution. Write to her at dermnews@mdedge.com.

References

1. Mahmud MR et al. Gut Microbes. 2022 Jan-Dec;14(1):2096995. doi: 10.1080/19490976.2022.2096995.

2. Sinha S et al. Clin Dermatol. 2021 Sep-Oct;39(5):829-839. doi: 10.1016/j.clindermatol.2021.08.021.

3. Gao T et al. Nutrients. 2023 Jul 13;15(14):3123. doi: 10.3390/nu15143123.

4. Miyazaki K et al. Benef Microbes. 2014 Jun 1;5(2):121-128. doi: 10.3920/BM2012.0066.

5. Shen Q et al. Anaerobe. 2010 Aug;16(4):380-386. doi: 10.1016/j.anaerobe.2010.06.006.

6. Peran L et al. Int J Colorectal Dis. 2006 Dec;21(8):737-746. doi: 10.1007/s00384-005-0773-y.

7. Kodali VP, Sen R. Biotechnol J. 2008 Feb;3(2):245-251. doi: 10.1002/biot.200700208.

8. Roudsari MR et al. Health effects of probiotics on the skin. Crit Rev Food Sci Nutr. 2015;55(9):1219-40. doi: 10.1080/10408398.2012.680078.

9. Ashoori Y et al. Biomed Res Int. 2020 Dec 28;2020:8868618. doi: 10.1155/2020/8868618.

10. Simmering R, Breves R. Hautarzt. 2009 Oct;60(10):809-814. doi: 10.1007/s00105-009-1759-4.

11. Bockmuhl D. IFSSC Mag. 2006 Sep 30;9[3]:1-5.

12. Lew LC, Liong MT. J Appl Microbiol. 2013 May;114(5):1241-1253. doi: 10.1111/jam.12137.

13. Gueniche A. US Patent, US 20100226892. 2010.

14. Miyazaki K et al. Skin Pharmacol Appl Skin Physiol. 2003 Mar-Apr;16(2):108-116. doi: 10.1159/000069031.

15. Miyazaki et al. J Cosmet Sci. 2004 Sep-Oct;55(5):473-479.16. Xie A et al. Front Cell Infect Microbiol. 2023 Feb 16;13:1137275. doi: 10.3389/fcimb.2023.1137275.

17. Delavie Sciences. Skincare Science: Aeonia. Skincare from the Stars.

. Accessed December 12, 2024. 

18. Stern C. CosmeticsDesign USA. September 7, 2023.

Outrageous assertions with little evidence are not new. Even the famous statement “There’s a sucker born every minute,” long attributed to 1800s showman P.T. Barnum, lacks evidence that the circus founder uttered the remark. The message itself and the snippet of a story about the message may be pertinent, though, when we consider the touted benefits of Bacillus lysate for the skin. The focus of this column will be the foundation for the use of probiotics and prebiotics in skin care and then claims made about this skin care ingredient derived from a particular strain of Bacillus bacteria.

The benefits of prebiotics and probiotics to human health, and skin health in particular, have been investigated with increasing frequency in the last 20 years. Typically, this topic is broached in the context of the gut-skin axis and the skin and gut microbiomes.^1-3 In 2014, Miyazaki et al. found that phenols produced by gut bacteria spurred skin disorders and that decreasing phenols with probiotics and/or prebiotics can restore or maintain cutaneous health.⁴

Probiotics have been associated with antioxidant activity, primarily because of the presence of antioxidant enzymes (eg, superoxide dismutase), the delivery of antioxidant substances (eg, glutathione), and extracellular polysaccharide synthesis.^5-8 Further, probiotics are known to synthesize a cascade of substances with anti-inflammatory, antibacterial, immunomodulatory, and angiogenetic functions that can contribute to wound healing.⁹ The use of probiotics in skin health largely relies on applying inactivated beneficial bacteria.¹⁰ Prebiotics, which are non-digestible plant-based carbohydrates that aid digestion, inhibit pathogens, and support beneficial bacteria, are known to rebalance the skin microflora.¹⁰ In addition, prebiotics are considered a robust option to replace live bacteria in skin formulations.¹¹ Bacterial cell lysates, which include bacterial metabolites, cell walls, and dead bacteria, are incorporated into skin care products as well.¹²

Probiotics and Wound Healing

In 2020, Ashoori et al. reported on their study of three formulations composed of probiotic supernatant (Lactobacillus reuteri, L. fermentum, and Bacillus subtilis sp. natto)-loaded chitosan nanogels prepared from cultures. They evaluated the effectiveness and dressing activity of the formulations by gauging wound closure and histological results in Sprague-Dawley rats. The researchers found that all probiotic lysate preparations conferred healing properties, with the Bacillus subtilis natto yielding the best wound healing quality. They concluded that probiotic lysate nanogels impart a range of benefits, such as favorable wound closure rates, improved appearance, and suitable histological results upon in vivo examination, supporting the potential use of such formulations to treat wounds.⁹

Probiotics and Treating Skin Disorders

A 2015 review by Roudsari et al. suggests that probiotics display the potential for preventing and treating various skin disorders, including acne, atopic dermatitis, allergic inflammation or hypersensitivity, eczema, photodamage, and wounds.⁸ They reported that in a US patent, Gueniche revealed ways to employ at least one probiotic microorganism (from Lactobacillus and/or Bifidobacterium) as an active agent to prevent or treat skin irritation.^8,13 In addition, they noted that L. brevis was used successfully by DeSimone in 2003 to promote apoptosis and/or diminish inflammation, particularly in creams and ointments to alleviate inflammation.8

At around the same time, Miyazaki et al. reported that Bifidobacterium-fermented soy milk extract stimulated the production of hyaluronic acid (HA) in organotypic cultures of human keratinocytes, cultures of human skin fibroblasts, and hairless mouse skin after 2 weeks of topical application and has the potential to promote HA synthesis in the epidermis and dermis and thus act as an anti-aging agent.¹⁴ In another study, Miyazaki et al. investigated the impact of Bifidobacterium-fermented soy milk extract containing genistein and daidzein on the HA content of hairless mouse as well as human skin. After 6 weeks of topical application in mice, skin elasticity, viscoelasticity, hydration, and thickness improved, and HA content increased. In addition, after 3 months of topical application of a 10% Bifidobacterium-fermented soy milk extract gel to the human forearm, decreases in skin elasticity were significantly mitigated.¹⁵More recently, in 2023, Xie et al. reviewed clinical and experimental data on the use of various species of Lactobacillus for the treatment and prevention of atopic dermatitis (AD). They found evidence that multiple species (L. rhamnosus in animal and clinical experiments) appeared to be effective in preventing and treating AD, with L. acidophilus lessening symptoms and reported to be safe, L. plantarum improving symptoms through immunomodulatory activity, and L. sakei demonstrating anti-inflammatory and skin barrier protective activity. The authors also noted that L. paracasei exhibited anti-inflammatory effects on AD-like skin lesions, and L. reuteri supplementation prevented AD development. Overall, they called for more in vivo studies and randomized controlled clinical trials to fully elucidate the wide-ranging potential of Lactobacillus species in treating and preventing AD.¹⁶

The Darker Side of Using Prebiotic Species in Skin Care?

According to manufacturer Delavie Sciences, its Aeonia product line was based on research conducted on the International Space Station, which allowed for its patented microorganism to be exposed to the conditions of outer space. This cornerstone ingredient, Bacillus lysate, once returned to Earth, reportedly exhibited anti-aging and UV-protective characteristics. The product line has been described as a prebiotic that contributes to a healthy skin barrier.¹⁷

In a September 2023 interview in CosmeticsDesign, the president of Delavie Sciences clarified that its Bacillus lysate contains no live bacteria and that it is not a probiotic, but rather, the certified prebiotic lysate is a Bacillus extract that has been used to strengthen the SPF potency of skin care formulations.¹⁸ Because of the research performed on the International Space Station, the manufacturers are claiming these ingredients could be “out-of-this-world” as a way to promote results that have, as yet, not been verified by peer review. 

 

Conclusion

Probiotics and prebiotics continue to be the focus of multiple lines of research for their applications and further potential in skin care. In the case of the Bacillus lysate prebiotic compound, there is a kernel of an interesting idea here, at the very least. But proprietary research limits our ability to render a comprehensive evaluation at this time. Such bold and outrageous claims spur more skepticism than optimism. However, lysates are the latest thing in skin care — so we need to keep watch on the developments to stay current. But that’s what you have me for, I’ll help keep you current on new ingredient findings. If you are on LinkedIn, come connect with me. I post breaking ingredient news and skin care trends there to help you answer patient questions. When you are asked if these lysates work, the answer is: All the data we have on bacillus extract are from computer analysis of the ingredient properties and not on the actual formulations or products. Stay tuned.

Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur in Miami. She founded the division of cosmetic dermatology at the University of Miami in 1997. The third edition of her bestselling textbook, “Cosmetic Dermatology,” was published in 2022. Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Galderma, Johnson & Johnson, and Burt’s Bees. She is the CEO of Skin Type Solutions Inc., a SaaS company used to generate skin care routines in office and as a ecommerce solution. Write to her at dermnews@mdedge.com.

References

1. Mahmud MR et al. Gut Microbes. 2022 Jan-Dec;14(1):2096995. doi: 10.1080/19490976.2022.2096995.

2. Sinha S et al. Clin Dermatol. 2021 Sep-Oct;39(5):829-839. doi: 10.1016/j.clindermatol.2021.08.021.

3. Gao T et al. Nutrients. 2023 Jul 13;15(14):3123. doi: 10.3390/nu15143123.

4. Miyazaki K et al. Benef Microbes. 2014 Jun 1;5(2):121-128. doi: 10.3920/BM2012.0066.

5. Shen Q et al. Anaerobe. 2010 Aug;16(4):380-386. doi: 10.1016/j.anaerobe.2010.06.006.

6. Peran L et al. Int J Colorectal Dis. 2006 Dec;21(8):737-746. doi: 10.1007/s00384-005-0773-y.

7. Kodali VP, Sen R. Biotechnol J. 2008 Feb;3(2):245-251. doi: 10.1002/biot.200700208.

8. Roudsari MR et al. Health effects of probiotics on the skin. Crit Rev Food Sci Nutr. 2015;55(9):1219-40. doi: 10.1080/10408398.2012.680078.

9. Ashoori Y et al. Biomed Res Int. 2020 Dec 28;2020:8868618. doi: 10.1155/2020/8868618.

10. Simmering R, Breves R. Hautarzt. 2009 Oct;60(10):809-814. doi: 10.1007/s00105-009-1759-4.

11. Bockmuhl D. IFSSC Mag. 2006 Sep 30;9[3]:1-5.

12. Lew LC, Liong MT. J Appl Microbiol. 2013 May;114(5):1241-1253. doi: 10.1111/jam.12137.

13. Gueniche A. US Patent, US 20100226892. 2010.

14. Miyazaki K et al. Skin Pharmacol Appl Skin Physiol. 2003 Mar-Apr;16(2):108-116. doi: 10.1159/000069031.

15. Miyazaki et al. J Cosmet Sci. 2004 Sep-Oct;55(5):473-479.16. Xie A et al. Front Cell Infect Microbiol. 2023 Feb 16;13:1137275. doi: 10.3389/fcimb.2023.1137275.

17. Delavie Sciences. Skincare Science: Aeonia. Skincare from the Stars.

. Accessed December 12, 2024. 

18. Stern C. CosmeticsDesign USA. September 7, 2023.

Outrageous assertions with little evidence are not new. Even the famous statement “There’s a sucker born every minute,” long attributed to 1800s showman P.T. Barnum, lacks evidence that the circus founder uttered the remark. The message itself and the snippet of a story about the message may be pertinent, though, when we consider the touted benefits of Bacillus lysate for the skin. The focus of this column will be the foundation for the use of probiotics and prebiotics in skin care and then claims made about this skin care ingredient derived from a particular strain of Bacillus bacteria.

The benefits of prebiotics and probiotics to human health, and skin health in particular, have been investigated with increasing frequency in the last 20 years. Typically, this topic is broached in the context of the gut-skin axis and the skin and gut microbiomes.^1-3 In 2014, Miyazaki et al. found that phenols produced by gut bacteria spurred skin disorders and that decreasing phenols with probiotics and/or prebiotics can restore or maintain cutaneous health.⁴

Probiotics have been associated with antioxidant activity, primarily because of the presence of antioxidant enzymes (eg, superoxide dismutase), the delivery of antioxidant substances (eg, glutathione), and extracellular polysaccharide synthesis.^5-8 Further, probiotics are known to synthesize a cascade of substances with anti-inflammatory, antibacterial, immunomodulatory, and angiogenetic functions that can contribute to wound healing.⁹ The use of probiotics in skin health largely relies on applying inactivated beneficial bacteria.¹⁰ Prebiotics, which are non-digestible plant-based carbohydrates that aid digestion, inhibit pathogens, and support beneficial bacteria, are known to rebalance the skin microflora.¹⁰ In addition, prebiotics are considered a robust option to replace live bacteria in skin formulations.¹¹ Bacterial cell lysates, which include bacterial metabolites, cell walls, and dead bacteria, are incorporated into skin care products as well.¹²

Probiotics and Wound Healing

In 2020, Ashoori et al. reported on their study of three formulations composed of probiotic supernatant (Lactobacillus reuteri, L. fermentum, and Bacillus subtilis sp. natto)-loaded chitosan nanogels prepared from cultures. They evaluated the effectiveness and dressing activity of the formulations by gauging wound closure and histological results in Sprague-Dawley rats. The researchers found that all probiotic lysate preparations conferred healing properties, with the Bacillus subtilis natto yielding the best wound healing quality. They concluded that probiotic lysate nanogels impart a range of benefits, such as favorable wound closure rates, improved appearance, and suitable histological results upon in vivo examination, supporting the potential use of such formulations to treat wounds.⁹

Probiotics and Treating Skin Disorders

A 2015 review by Roudsari et al. suggests that probiotics display the potential for preventing and treating various skin disorders, including acne, atopic dermatitis, allergic inflammation or hypersensitivity, eczema, photodamage, and wounds.⁸ They reported that in a US patent, Gueniche revealed ways to employ at least one probiotic microorganism (from Lactobacillus and/or Bifidobacterium) as an active agent to prevent or treat skin irritation.^8,13 In addition, they noted that L. brevis was used successfully by DeSimone in 2003 to promote apoptosis and/or diminish inflammation, particularly in creams and ointments to alleviate inflammation.8

At around the same time, Miyazaki et al. reported that Bifidobacterium-fermented soy milk extract stimulated the production of hyaluronic acid (HA) in organotypic cultures of human keratinocytes, cultures of human skin fibroblasts, and hairless mouse skin after 2 weeks of topical application and has the potential to promote HA synthesis in the epidermis and dermis and thus act as an anti-aging agent.¹⁴ In another study, Miyazaki et al. investigated the impact of Bifidobacterium-fermented soy milk extract containing genistein and daidzein on the HA content of hairless mouse as well as human skin. After 6 weeks of topical application in mice, skin elasticity, viscoelasticity, hydration, and thickness improved, and HA content increased. In addition, after 3 months of topical application of a 10% Bifidobacterium-fermented soy milk extract gel to the human forearm, decreases in skin elasticity were significantly mitigated.¹⁵More recently, in 2023, Xie et al. reviewed clinical and experimental data on the use of various species of Lactobacillus for the treatment and prevention of atopic dermatitis (AD). They found evidence that multiple species (L. rhamnosus in animal and clinical experiments) appeared to be effective in preventing and treating AD, with L. acidophilus lessening symptoms and reported to be safe, L. plantarum improving symptoms through immunomodulatory activity, and L. sakei demonstrating anti-inflammatory and skin barrier protective activity. The authors also noted that L. paracasei exhibited anti-inflammatory effects on AD-like skin lesions, and L. reuteri supplementation prevented AD development. Overall, they called for more in vivo studies and randomized controlled clinical trials to fully elucidate the wide-ranging potential of Lactobacillus species in treating and preventing AD.¹⁶

The Darker Side of Using Prebiotic Species in Skin Care?

According to manufacturer Delavie Sciences, its Aeonia product line was based on research conducted on the International Space Station, which allowed for its patented microorganism to be exposed to the conditions of outer space. This cornerstone ingredient, Bacillus lysate, once returned to Earth, reportedly exhibited anti-aging and UV-protective characteristics. The product line has been described as a prebiotic that contributes to a healthy skin barrier.¹⁷

In a September 2023 interview in CosmeticsDesign, the president of Delavie Sciences clarified that its Bacillus lysate contains no live bacteria and that it is not a probiotic, but rather, the certified prebiotic lysate is a Bacillus extract that has been used to strengthen the SPF potency of skin care formulations.¹⁸ Because of the research performed on the International Space Station, the manufacturers are claiming these ingredients could be “out-of-this-world” as a way to promote results that have, as yet, not been verified by peer review. 

 

Conclusion

Probiotics and prebiotics continue to be the focus of multiple lines of research for their applications and further potential in skin care. In the case of the Bacillus lysate prebiotic compound, there is a kernel of an interesting idea here, at the very least. But proprietary research limits our ability to render a comprehensive evaluation at this time. Such bold and outrageous claims spur more skepticism than optimism. However, lysates are the latest thing in skin care — so we need to keep watch on the developments to stay current. But that’s what you have me for, I’ll help keep you current on new ingredient findings. If you are on LinkedIn, come connect with me. I post breaking ingredient news and skin care trends there to help you answer patient questions. When you are asked if these lysates work, the answer is: All the data we have on bacillus extract are from computer analysis of the ingredient properties and not on the actual formulations or products. Stay tuned.

Dr. Baumann is a private practice dermatologist, researcher, author, and entrepreneur in Miami. She founded the division of cosmetic dermatology at the University of Miami in 1997. The third edition of her bestselling textbook, “Cosmetic Dermatology,” was published in 2022. Dr. Baumann has received funding for advisory boards and/or clinical research trials from Allergan, Galderma, Johnson & Johnson, and Burt’s Bees. She is the CEO of Skin Type Solutions Inc., a SaaS company used to generate skin care routines in office and as a ecommerce solution. Write to her at dermnews@mdedge.com.

References

1. Mahmud MR et al. Gut Microbes. 2022 Jan-Dec;14(1):2096995. doi: 10.1080/19490976.2022.2096995.

2. Sinha S et al. Clin Dermatol. 2021 Sep-Oct;39(5):829-839. doi: 10.1016/j.clindermatol.2021.08.021.

3. Gao T et al. Nutrients. 2023 Jul 13;15(14):3123. doi: 10.3390/nu15143123.

4. Miyazaki K et al. Benef Microbes. 2014 Jun 1;5(2):121-128. doi: 10.3920/BM2012.0066.

5. Shen Q et al. Anaerobe. 2010 Aug;16(4):380-386. doi: 10.1016/j.anaerobe.2010.06.006.

6. Peran L et al. Int J Colorectal Dis. 2006 Dec;21(8):737-746. doi: 10.1007/s00384-005-0773-y.

7. Kodali VP, Sen R. Biotechnol J. 2008 Feb;3(2):245-251. doi: 10.1002/biot.200700208.

8. Roudsari MR et al. Health effects of probiotics on the skin. Crit Rev Food Sci Nutr. 2015;55(9):1219-40. doi: 10.1080/10408398.2012.680078.

9. Ashoori Y et al. Biomed Res Int. 2020 Dec 28;2020:8868618. doi: 10.1155/2020/8868618.

10. Simmering R, Breves R. Hautarzt. 2009 Oct;60(10):809-814. doi: 10.1007/s00105-009-1759-4.

11. Bockmuhl D. IFSSC Mag. 2006 Sep 30;9[3]:1-5.

12. Lew LC, Liong MT. J Appl Microbiol. 2013 May;114(5):1241-1253. doi: 10.1111/jam.12137.

13. Gueniche A. US Patent, US 20100226892. 2010.

14. Miyazaki K et al. Skin Pharmacol Appl Skin Physiol. 2003 Mar-Apr;16(2):108-116. doi: 10.1159/000069031.

15. Miyazaki et al. J Cosmet Sci. 2004 Sep-Oct;55(5):473-479.16. Xie A et al. Front Cell Infect Microbiol. 2023 Feb 16;13:1137275. doi: 10.3389/fcimb.2023.1137275.

17. Delavie Sciences. Skincare Science: Aeonia. Skincare from the Stars.

. Accessed December 12, 2024. 

18. Stern C. CosmeticsDesign USA. September 7, 2023.

TOPLINE:

An analysis of acne-specific patient-reported outcome measures (PROMs) identified LGBTQ+-noninclusive language in four of nine measures, with heteronormative terms used in three of six measures addressing intimate relationships. 

METHODOLOGY:

• Researchers conducted an inductive thematic analysis of 22 PROMs for acne, identified through a PubMed search.
• LGBTQ+-inclusive language was defined per the National Institutes of Health style guide.
• The analysis included 16 PROMs: Nine were acne-specific with 56 relevant items, 4 were dermatology-specific with 28 items, and 4 were health-related with 43 items.

TAKEAWAY:

• LGBTQ+-noninclusive language was identified in four of nine acne-specific PROMs — the Acne Disability Index (ADI), Acne Quality of Life Scale (AQOL), Acne-Quality of Life (Acne-QoL), and Cardiff Acne Disability Index (CADI) — but not in health-related or dermatology-specific PROMs.
• Among PROMs addressing intimate relationships, three of six acne-specific measures (CADI, ADI, and Acne-QoL) used heteronormative language, while three acne-specific PROMs, three dermatology-specific PROMs, and one health-related PROM used nonheteronormative terminology (such as “partner”).
• All PROMs contained items with nongendered pronouns (such as “I” or “you” instead of “he” or “she”). However, the AQOL included gendered language (“brothers” and “sisters,” rather than “siblings”).
• Two acne-specific PROMs demonstrated partial LGBTQ+ inclusivity, incorporating some but not all LGBTQ+ identities.

IN PRACTICE:

“Using LGBTQ+-inclusive language may promote the acquisition of accurate and relevant data for patient care and clinical trials and even enhance patient-clinician relationships,” the authors of the study wrote. “While demographics such as sex, age, race, and ethnicity are commonly considered during patient-reported outcome development and validation,” wrote the authors of an accompanying editorial, the study highlights that “sexual orientation and gender identity should also be considered to ensure these measures have similar performance across diverse populations.” 

SOURCE:

The study was led by Twan Sia, BA, Department of Dermatology, Stanford University School of Medicine in California. The authors of the editorial were John S. Barbieri, MD, MBA, Department of Dermatology, Brigham and Women’s Hospital, Boston, Massachusetts, and Mya L. Roberson, MSPH, PhD, University of North Carolina at Chapel Hill.

LIMITATIONS:

The study was limited to the analysis of only English-language PROMs. 

DISCLOSURES:

Two study authors disclosed receiving grants or personal fees from various sources, including pharmaceutical companies outside the submitted work. Barbieri disclosed receiving consulting fees from Dexcel Pharma and Honeydew Care; Roberson disclosed receiving consulting fees from the National Committee for Quality Assurance.

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 first appeared on Medscape.com.

TOPLINE:

An analysis of acne-specific patient-reported outcome measures (PROMs) identified LGBTQ+-noninclusive language in four of nine measures, with heteronormative terms used in three of six measures addressing intimate relationships. 

METHODOLOGY:

• Researchers conducted an inductive thematic analysis of 22 PROMs for acne, identified through a PubMed search.
• LGBTQ+-inclusive language was defined per the National Institutes of Health style guide.
• The analysis included 16 PROMs: Nine were acne-specific with 56 relevant items, 4 were dermatology-specific with 28 items, and 4 were health-related with 43 items.

TAKEAWAY:

• LGBTQ+-noninclusive language was identified in four of nine acne-specific PROMs — the Acne Disability Index (ADI), Acne Quality of Life Scale (AQOL), Acne-Quality of Life (Acne-QoL), and Cardiff Acne Disability Index (CADI) — but not in health-related or dermatology-specific PROMs.
• Among PROMs addressing intimate relationships, three of six acne-specific measures (CADI, ADI, and Acne-QoL) used heteronormative language, while three acne-specific PROMs, three dermatology-specific PROMs, and one health-related PROM used nonheteronormative terminology (such as “partner”).
• All PROMs contained items with nongendered pronouns (such as “I” or “you” instead of “he” or “she”). However, the AQOL included gendered language (“brothers” and “sisters,” rather than “siblings”).
• Two acne-specific PROMs demonstrated partial LGBTQ+ inclusivity, incorporating some but not all LGBTQ+ identities.

IN PRACTICE:

“Using LGBTQ+-inclusive language may promote the acquisition of accurate and relevant data for patient care and clinical trials and even enhance patient-clinician relationships,” the authors of the study wrote. “While demographics such as sex, age, race, and ethnicity are commonly considered during patient-reported outcome development and validation,” wrote the authors of an accompanying editorial, the study highlights that “sexual orientation and gender identity should also be considered to ensure these measures have similar performance across diverse populations.” 

SOURCE:

The study was led by Twan Sia, BA, Department of Dermatology, Stanford University School of Medicine in California. The authors of the editorial were John S. Barbieri, MD, MBA, Department of Dermatology, Brigham and Women’s Hospital, Boston, Massachusetts, and Mya L. Roberson, MSPH, PhD, University of North Carolina at Chapel Hill.

LIMITATIONS:

The study was limited to the analysis of only English-language PROMs. 

DISCLOSURES:

Two study authors disclosed receiving grants or personal fees from various sources, including pharmaceutical companies outside the submitted work. Barbieri disclosed receiving consulting fees from Dexcel Pharma and Honeydew Care; Roberson disclosed receiving consulting fees from the National Committee for Quality Assurance.

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 first appeared on Medscape.com.

TOPLINE:

An analysis of acne-specific patient-reported outcome measures (PROMs) identified LGBTQ+-noninclusive language in four of nine measures, with heteronormative terms used in three of six measures addressing intimate relationships. 

METHODOLOGY:

• Researchers conducted an inductive thematic analysis of 22 PROMs for acne, identified through a PubMed search.
• LGBTQ+-inclusive language was defined per the National Institutes of Health style guide.
• The analysis included 16 PROMs: Nine were acne-specific with 56 relevant items, 4 were dermatology-specific with 28 items, and 4 were health-related with 43 items.

TAKEAWAY:

• LGBTQ+-noninclusive language was identified in four of nine acne-specific PROMs — the Acne Disability Index (ADI), Acne Quality of Life Scale (AQOL), Acne-Quality of Life (Acne-QoL), and Cardiff Acne Disability Index (CADI) — but not in health-related or dermatology-specific PROMs.
• Among PROMs addressing intimate relationships, three of six acne-specific measures (CADI, ADI, and Acne-QoL) used heteronormative language, while three acne-specific PROMs, three dermatology-specific PROMs, and one health-related PROM used nonheteronormative terminology (such as “partner”).
• All PROMs contained items with nongendered pronouns (such as “I” or “you” instead of “he” or “she”). However, the AQOL included gendered language (“brothers” and “sisters,” rather than “siblings”).
• Two acne-specific PROMs demonstrated partial LGBTQ+ inclusivity, incorporating some but not all LGBTQ+ identities.

IN PRACTICE:

“Using LGBTQ+-inclusive language may promote the acquisition of accurate and relevant data for patient care and clinical trials and even enhance patient-clinician relationships,” the authors of the study wrote. “While demographics such as sex, age, race, and ethnicity are commonly considered during patient-reported outcome development and validation,” wrote the authors of an accompanying editorial, the study highlights that “sexual orientation and gender identity should also be considered to ensure these measures have similar performance across diverse populations.” 

SOURCE:

The study was led by Twan Sia, BA, Department of Dermatology, Stanford University School of Medicine in California. The authors of the editorial were John S. Barbieri, MD, MBA, Department of Dermatology, Brigham and Women’s Hospital, Boston, Massachusetts, and Mya L. Roberson, MSPH, PhD, University of North Carolina at Chapel Hill.

LIMITATIONS:

The study was limited to the analysis of only English-language PROMs. 

DISCLOSURES:

Two study authors disclosed receiving grants or personal fees from various sources, including pharmaceutical companies outside the submitted work. Barbieri disclosed receiving consulting fees from Dexcel Pharma and Honeydew Care; Roberson disclosed receiving consulting fees from the National Committee for Quality Assurance.

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 first appeared on Medscape.com.

LAS VEGAS — For clinicians who rely on generic tretinoin 0.5% as their go-to treatment for patients with acne, Shanna Miranti, MPAS, PA-C, offers some straightforward advice: You can do better.

“Friends don’t let friends write generic tretinoin only because there are so many better options out there,” Miranti, who practices dermatology in Naples, Florida, said at the Society of Dermatology Physician Associates (SDPA) 22nd Annual Fall Dermatology Conference. “Don’t get lazy; your patients deserve better.”

 

In her wide-ranging presentation, Miranti described the four pillars of acne pathogenesis as increased sebum production caused by androgens, follicular hyperkeratinization in the pilosebaceous unit, colonization by Cutibacterium acnes (formerly Proprionibacterium acnes), and inflammation. Acne “starts with androgens, but this is a cascade, so you have to find treatment options that hit as many of these four pillars as possible,” Miranti explained. “If you’re only using generic tretinoin, you’re only hitting maybe two of the four pillars at best.”

She then discussed the best treatment options for each pillar:

Follicular plugging and hyperkeratinization. Topical retinoids, including tretinoin, adapalene, tazarotene, and trifarotene, are highly effective for this issue. Systemic isotretinoin is also a strong option. For patients who are pregnant or trying to conceive, azelaic acid is a helpful alternative.

Excessive sebum production and androgens. “This may be the genesis of when acne begins — during puberty,” Miranti said. “With rising androgens comes rising amounts of sebum.” The only topical treatment that specifically targets this is clascoterone (Winlevi), which should be applied twice daily. For systemic management of excessive sebum, isotretinoin is highly effective. In women, spironolactone (50 mg daily, or split into two doses) and oral contraceptives are also options.

Inflammation. Topical options include retinoids, antibiotics, benzoyl peroxide (BPO), topical dapsone, azelaic acid, and clascoterone. Systemic options include isotretinoin; the antibiotics doxycycline, minocycline, and sarecycline; spironolactone; and oral contraceptives. “So, when you see patients with intense inflammation, and they’re starting to get post-inflammatory erythema or post-inflammatory hyperpigmentation, you need something to address this inflammatory problem,” she noted.

C acnes. Topical treatment options include BPO and antibiotics. However, topical antibiotics should never be used alone, Miranti said; they must always be combined with BPO to prevent bacterial resistance. Oral options include sarecycline, “which has a low propensity for antibiotic resistance and spares the gut microbiome to some degree,” and the “old-school” antibiotics doxycycline, minocycline, and tetracycline. “But all oral antibiotics should be used concomitantly with BPO,” she added.

Regardless of which treatment is chosen for any pillar, Miranti emphasized that monotherapy with a single agent is often insufficient. “Historically, we have combined therapies to treat the multiple causes of acne,” she said. “The average number of acne products used per patient is 2.53, but that’s also the average number of copays. We have to be conscious of that. If you are a mom with four kids who are on acne medication, you want to minimize your copay burden. So, if you can find a topical medication that hits three out of the four pillars of acne pathogenesis, that would be fantastic.” The only topical that targets excess sebum is clascoterone, she noted, and the only medication that hits all four pillars is isotretinoin.

In October 2023, the Food and Drug Administration approved a once-daily topical gel for patients aged 12 years or older that contains clindamycin 1.2%, adapalene 0.15%, and BPO 3.1%. The first-ever triple combination therapy, known as Cabtreo, was released to pharmacies in March 2024. In a phase 2 trial, researchers randomized 394 patients aged 9 years or older with moderate to severe acne to once-daily IDP-126, one of three dyad combination gels, or vehicle gel for 12 weeks. Patients in the Cabtreo arm achieved significantly greater lesion reductions than those in the vehicle arm (inflammatory: 78.3% vs 45.1%; noninflammatory: 70.0% vs 37.6%; P < .001 for both). They also experienced lesion reductions that were 9.2%-16.6% greater than those observed with any of the dyad combination gels. Miranti characterized the study results as “pretty phenomenal,” noting that the ease of use makes Cabtreo stand out as a treatment option. “Simplicity drives compliance, and compliance drives results,” she said. “This is one product to apply once a day. Any of you who have a teenage son like me, you know it is hard to get them to brush their teeth twice a day, let alone take medicine before they leave the house in the morning. This can be a home run for a lot of patients, and not just our teenagers. Adult females have done very well with this medication.”

In a network meta-analysis, researchers reviewed 221 randomized controlled trials to compare the efficacy of pharmacologic treatment for acne. The most effective treatment in reducing inflammatory and noninflammatory lesions was oral isotretinoin, followed by Cabtreo.

Miranti disclosed being a speaker, consultant, and/or an advisory board member for Arcutis Biotherapeutics, Bausch Health, Dermavant Sciences, Galderma, Incyte, LEO Pharma, Eli Lilly, Sun Pharma, Swift USA, and Verrica Pharmaceuticals.

A version of this article first appeared on Medscape.com.

LAS VEGAS — For clinicians who rely on generic tretinoin 0.5% as their go-to treatment for patients with acne, Shanna Miranti, MPAS, PA-C, offers some straightforward advice: You can do better.

“Friends don’t let friends write generic tretinoin only because there are so many better options out there,” Miranti, who practices dermatology in Naples, Florida, said at the Society of Dermatology Physician Associates (SDPA) 22nd Annual Fall Dermatology Conference. “Don’t get lazy; your patients deserve better.”

 

In her wide-ranging presentation, Miranti described the four pillars of acne pathogenesis as increased sebum production caused by androgens, follicular hyperkeratinization in the pilosebaceous unit, colonization by Cutibacterium acnes (formerly Proprionibacterium acnes), and inflammation. Acne “starts with androgens, but this is a cascade, so you have to find treatment options that hit as many of these four pillars as possible,” Miranti explained. “If you’re only using generic tretinoin, you’re only hitting maybe two of the four pillars at best.”

She then discussed the best treatment options for each pillar:

Follicular plugging and hyperkeratinization. Topical retinoids, including tretinoin, adapalene, tazarotene, and trifarotene, are highly effective for this issue. Systemic isotretinoin is also a strong option. For patients who are pregnant or trying to conceive, azelaic acid is a helpful alternative.

Excessive sebum production and androgens. “This may be the genesis of when acne begins — during puberty,” Miranti said. “With rising androgens comes rising amounts of sebum.” The only topical treatment that specifically targets this is clascoterone (Winlevi), which should be applied twice daily. For systemic management of excessive sebum, isotretinoin is highly effective. In women, spironolactone (50 mg daily, or split into two doses) and oral contraceptives are also options.

Inflammation. Topical options include retinoids, antibiotics, benzoyl peroxide (BPO), topical dapsone, azelaic acid, and clascoterone. Systemic options include isotretinoin; the antibiotics doxycycline, minocycline, and sarecycline; spironolactone; and oral contraceptives. “So, when you see patients with intense inflammation, and they’re starting to get post-inflammatory erythema or post-inflammatory hyperpigmentation, you need something to address this inflammatory problem,” she noted.

C acnes. Topical treatment options include BPO and antibiotics. However, topical antibiotics should never be used alone, Miranti said; they must always be combined with BPO to prevent bacterial resistance. Oral options include sarecycline, “which has a low propensity for antibiotic resistance and spares the gut microbiome to some degree,” and the “old-school” antibiotics doxycycline, minocycline, and tetracycline. “But all oral antibiotics should be used concomitantly with BPO,” she added.

Regardless of which treatment is chosen for any pillar, Miranti emphasized that monotherapy with a single agent is often insufficient. “Historically, we have combined therapies to treat the multiple causes of acne,” she said. “The average number of acne products used per patient is 2.53, but that’s also the average number of copays. We have to be conscious of that. If you are a mom with four kids who are on acne medication, you want to minimize your copay burden. So, if you can find a topical medication that hits three out of the four pillars of acne pathogenesis, that would be fantastic.” The only topical that targets excess sebum is clascoterone, she noted, and the only medication that hits all four pillars is isotretinoin.

In October 2023, the Food and Drug Administration approved a once-daily topical gel for patients aged 12 years or older that contains clindamycin 1.2%, adapalene 0.15%, and BPO 3.1%. The first-ever triple combination therapy, known as Cabtreo, was released to pharmacies in March 2024. In a phase 2 trial, researchers randomized 394 patients aged 9 years or older with moderate to severe acne to once-daily IDP-126, one of three dyad combination gels, or vehicle gel for 12 weeks. Patients in the Cabtreo arm achieved significantly greater lesion reductions than those in the vehicle arm (inflammatory: 78.3% vs 45.1%; noninflammatory: 70.0% vs 37.6%; P < .001 for both). They also experienced lesion reductions that were 9.2%-16.6% greater than those observed with any of the dyad combination gels. Miranti characterized the study results as “pretty phenomenal,” noting that the ease of use makes Cabtreo stand out as a treatment option. “Simplicity drives compliance, and compliance drives results,” she said. “This is one product to apply once a day. Any of you who have a teenage son like me, you know it is hard to get them to brush their teeth twice a day, let alone take medicine before they leave the house in the morning. This can be a home run for a lot of patients, and not just our teenagers. Adult females have done very well with this medication.”

In a network meta-analysis, researchers reviewed 221 randomized controlled trials to compare the efficacy of pharmacologic treatment for acne. The most effective treatment in reducing inflammatory and noninflammatory lesions was oral isotretinoin, followed by Cabtreo.

Miranti disclosed being a speaker, consultant, and/or an advisory board member for Arcutis Biotherapeutics, Bausch Health, Dermavant Sciences, Galderma, Incyte, LEO Pharma, Eli Lilly, Sun Pharma, Swift USA, and Verrica Pharmaceuticals.

A version of this article first appeared on Medscape.com.

LAS VEGAS — For clinicians who rely on generic tretinoin 0.5% as their go-to treatment for patients with acne, Shanna Miranti, MPAS, PA-C, offers some straightforward advice: You can do better.

“Friends don’t let friends write generic tretinoin only because there are so many better options out there,” Miranti, who practices dermatology in Naples, Florida, said at the Society of Dermatology Physician Associates (SDPA) 22nd Annual Fall Dermatology Conference. “Don’t get lazy; your patients deserve better.”

 

In her wide-ranging presentation, Miranti described the four pillars of acne pathogenesis as increased sebum production caused by androgens, follicular hyperkeratinization in the pilosebaceous unit, colonization by Cutibacterium acnes (formerly Proprionibacterium acnes), and inflammation. Acne “starts with androgens, but this is a cascade, so you have to find treatment options that hit as many of these four pillars as possible,” Miranti explained. “If you’re only using generic tretinoin, you’re only hitting maybe two of the four pillars at best.”

She then discussed the best treatment options for each pillar:

Follicular plugging and hyperkeratinization. Topical retinoids, including tretinoin, adapalene, tazarotene, and trifarotene, are highly effective for this issue. Systemic isotretinoin is also a strong option. For patients who are pregnant or trying to conceive, azelaic acid is a helpful alternative.

Excessive sebum production and androgens. “This may be the genesis of when acne begins — during puberty,” Miranti said. “With rising androgens comes rising amounts of sebum.” The only topical treatment that specifically targets this is clascoterone (Winlevi), which should be applied twice daily. For systemic management of excessive sebum, isotretinoin is highly effective. In women, spironolactone (50 mg daily, or split into two doses) and oral contraceptives are also options.

Inflammation. Topical options include retinoids, antibiotics, benzoyl peroxide (BPO), topical dapsone, azelaic acid, and clascoterone. Systemic options include isotretinoin; the antibiotics doxycycline, minocycline, and sarecycline; spironolactone; and oral contraceptives. “So, when you see patients with intense inflammation, and they’re starting to get post-inflammatory erythema or post-inflammatory hyperpigmentation, you need something to address this inflammatory problem,” she noted.

C acnes. Topical treatment options include BPO and antibiotics. However, topical antibiotics should never be used alone, Miranti said; they must always be combined with BPO to prevent bacterial resistance. Oral options include sarecycline, “which has a low propensity for antibiotic resistance and spares the gut microbiome to some degree,” and the “old-school” antibiotics doxycycline, minocycline, and tetracycline. “But all oral antibiotics should be used concomitantly with BPO,” she added.

Regardless of which treatment is chosen for any pillar, Miranti emphasized that monotherapy with a single agent is often insufficient. “Historically, we have combined therapies to treat the multiple causes of acne,” she said. “The average number of acne products used per patient is 2.53, but that’s also the average number of copays. We have to be conscious of that. If you are a mom with four kids who are on acne medication, you want to minimize your copay burden. So, if you can find a topical medication that hits three out of the four pillars of acne pathogenesis, that would be fantastic.” The only topical that targets excess sebum is clascoterone, she noted, and the only medication that hits all four pillars is isotretinoin.

In October 2023, the Food and Drug Administration approved a once-daily topical gel for patients aged 12 years or older that contains clindamycin 1.2%, adapalene 0.15%, and BPO 3.1%. The first-ever triple combination therapy, known as Cabtreo, was released to pharmacies in March 2024. In a phase 2 trial, researchers randomized 394 patients aged 9 years or older with moderate to severe acne to once-daily IDP-126, one of three dyad combination gels, or vehicle gel for 12 weeks. Patients in the Cabtreo arm achieved significantly greater lesion reductions than those in the vehicle arm (inflammatory: 78.3% vs 45.1%; noninflammatory: 70.0% vs 37.6%; P < .001 for both). They also experienced lesion reductions that were 9.2%-16.6% greater than those observed with any of the dyad combination gels. Miranti characterized the study results as “pretty phenomenal,” noting that the ease of use makes Cabtreo stand out as a treatment option. “Simplicity drives compliance, and compliance drives results,” she said. “This is one product to apply once a day. Any of you who have a teenage son like me, you know it is hard to get them to brush their teeth twice a day, let alone take medicine before they leave the house in the morning. This can be a home run for a lot of patients, and not just our teenagers. Adult females have done very well with this medication.”

In a network meta-analysis, researchers reviewed 221 randomized controlled trials to compare the efficacy of pharmacologic treatment for acne. The most effective treatment in reducing inflammatory and noninflammatory lesions was oral isotretinoin, followed by Cabtreo.

Miranti disclosed being a speaker, consultant, and/or an advisory board member for Arcutis Biotherapeutics, Bausch Health, Dermavant Sciences, Galderma, Incyte, LEO Pharma, Eli Lilly, Sun Pharma, Swift USA, and Verrica Pharmaceuticals.

A version of this article first appeared on Medscape.com.

TOPLINE:

Levonorgestrel intrauterine devices (IUDs) are associated with significantly more reports of acne, alopecia, and hirsutism compared with copper IUDs, with some differences between the available levonorgestrel IUDs.

METHODOLOGY:

• Researchers reviewed the US Food and Drug Administration (FDA) Adverse Events Reporting System (FAERS) through December 2023 for adverse events associated with levonorgestrel IUDs where IUDs were the only suspected cause, focusing on acne, alopecia, and hirsutism.
• They included 139,348 reports for the levonorgestrel IUDs (Mirena, Liletta, Kyleena, Skyla) and 50,450 reports for the copper IUD (Paragard).

TAKEAWAY:

• Levonorgestrel IUD users showed higher odds of reporting acne (odds ratio [OR], 3.21), alopecia (OR, 5.96), and hirsutism (OR, 15.48; all P < .0001) than copper IUD users.
• The Kyleena 19.5 mg levonorgestrel IUD was associated with the highest odds of acne reports (OR, 3.42), followed by the Mirena 52 mg (OR, 3.40) and Skyla 13.5 mg (OR, 2.30) levonorgestrel IUDs (all P < .0001).
• The Mirena IUD was associated with the highest odds of alopecia and hirsutism reports (OR, 6.62 and 17.43, respectively), followed by the Kyleena (ORs, 2.90 and 8.17, respectively) and Skyla (ORs, 2.69 and 1.48, respectively) IUDs (all P < .0001).
• Reports of acne, alopecia, and hirsutism were not significantly different between the Liletta 52 mg levonorgestrel IUD and the copper IUD.

IN PRACTICE:

“Overall, we identified significant associations between levonorgestrel IUDs and androgenic cutaneous adverse events,” the authors wrote. “Counseling prior to initiation of levonorgestrel IUDs should include information on possible cutaneous AEs including acne, alopecia, and hirsutism to guide contraceptive shared decision making,” they added.

 

SOURCE:

The study was led by Lydia Cassard, Cleveland Clinic Lerner College of Medicine, Cleveland, Ohio, and was published online November 3 in Journal of the American Academy of Dermatology.

LIMITATIONS:

FAERS database reports could not be verified, and differences in FDA approval dates for IUDs could have influenced reporting rates. Moreover, a lack of data on prior medication use limits the ability to determine if these AEs are a result of changes in androgenic or antiandrogenic medication use. Cutaneous adverse events associated with copper IUDs may have been underreported because of assumptions that a nonhormonal device would not cause these adverse events.

DISCLOSURES:

The authors did not report any funding source or conflict of interests.

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 first appeared on Medscape.com.

TOPLINE:

Levonorgestrel intrauterine devices (IUDs) are associated with significantly more reports of acne, alopecia, and hirsutism compared with copper IUDs, with some differences between the available levonorgestrel IUDs.

METHODOLOGY:

• Researchers reviewed the US Food and Drug Administration (FDA) Adverse Events Reporting System (FAERS) through December 2023 for adverse events associated with levonorgestrel IUDs where IUDs were the only suspected cause, focusing on acne, alopecia, and hirsutism.
• They included 139,348 reports for the levonorgestrel IUDs (Mirena, Liletta, Kyleena, Skyla) and 50,450 reports for the copper IUD (Paragard).

TAKEAWAY:

• Levonorgestrel IUD users showed higher odds of reporting acne (odds ratio [OR], 3.21), alopecia (OR, 5.96), and hirsutism (OR, 15.48; all P < .0001) than copper IUD users.
• The Kyleena 19.5 mg levonorgestrel IUD was associated with the highest odds of acne reports (OR, 3.42), followed by the Mirena 52 mg (OR, 3.40) and Skyla 13.5 mg (OR, 2.30) levonorgestrel IUDs (all P < .0001).
• The Mirena IUD was associated with the highest odds of alopecia and hirsutism reports (OR, 6.62 and 17.43, respectively), followed by the Kyleena (ORs, 2.90 and 8.17, respectively) and Skyla (ORs, 2.69 and 1.48, respectively) IUDs (all P < .0001).
• Reports of acne, alopecia, and hirsutism were not significantly different between the Liletta 52 mg levonorgestrel IUD and the copper IUD.

IN PRACTICE:

“Overall, we identified significant associations between levonorgestrel IUDs and androgenic cutaneous adverse events,” the authors wrote. “Counseling prior to initiation of levonorgestrel IUDs should include information on possible cutaneous AEs including acne, alopecia, and hirsutism to guide contraceptive shared decision making,” they added.

 

SOURCE:

The study was led by Lydia Cassard, Cleveland Clinic Lerner College of Medicine, Cleveland, Ohio, and was published online November 3 in Journal of the American Academy of Dermatology.

LIMITATIONS:

FAERS database reports could not be verified, and differences in FDA approval dates for IUDs could have influenced reporting rates. Moreover, a lack of data on prior medication use limits the ability to determine if these AEs are a result of changes in androgenic or antiandrogenic medication use. Cutaneous adverse events associated with copper IUDs may have been underreported because of assumptions that a nonhormonal device would not cause these adverse events.

DISCLOSURES:

The authors did not report any funding source or conflict of interests.

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 first appeared on Medscape.com.

TOPLINE:

Levonorgestrel intrauterine devices (IUDs) are associated with significantly more reports of acne, alopecia, and hirsutism compared with copper IUDs, with some differences between the available levonorgestrel IUDs.

METHODOLOGY:

• Researchers reviewed the US Food and Drug Administration (FDA) Adverse Events Reporting System (FAERS) through December 2023 for adverse events associated with levonorgestrel IUDs where IUDs were the only suspected cause, focusing on acne, alopecia, and hirsutism.
• They included 139,348 reports for the levonorgestrel IUDs (Mirena, Liletta, Kyleena, Skyla) and 50,450 reports for the copper IUD (Paragard).

TAKEAWAY:

• Levonorgestrel IUD users showed higher odds of reporting acne (odds ratio [OR], 3.21), alopecia (OR, 5.96), and hirsutism (OR, 15.48; all P < .0001) than copper IUD users.
• The Kyleena 19.5 mg levonorgestrel IUD was associated with the highest odds of acne reports (OR, 3.42), followed by the Mirena 52 mg (OR, 3.40) and Skyla 13.5 mg (OR, 2.30) levonorgestrel IUDs (all P < .0001).
• The Mirena IUD was associated with the highest odds of alopecia and hirsutism reports (OR, 6.62 and 17.43, respectively), followed by the Kyleena (ORs, 2.90 and 8.17, respectively) and Skyla (ORs, 2.69 and 1.48, respectively) IUDs (all P < .0001).
• Reports of acne, alopecia, and hirsutism were not significantly different between the Liletta 52 mg levonorgestrel IUD and the copper IUD.

IN PRACTICE:

“Overall, we identified significant associations between levonorgestrel IUDs and androgenic cutaneous adverse events,” the authors wrote. “Counseling prior to initiation of levonorgestrel IUDs should include information on possible cutaneous AEs including acne, alopecia, and hirsutism to guide contraceptive shared decision making,” they added.

 

SOURCE:

The study was led by Lydia Cassard, Cleveland Clinic Lerner College of Medicine, Cleveland, Ohio, and was published online November 3 in Journal of the American Academy of Dermatology.

LIMITATIONS:

FAERS database reports could not be verified, and differences in FDA approval dates for IUDs could have influenced reporting rates. Moreover, a lack of data on prior medication use limits the ability to determine if these AEs are a result of changes in androgenic or antiandrogenic medication use. Cutaneous adverse events associated with copper IUDs may have been underreported because of assumptions that a nonhormonal device would not cause these adverse events.

DISCLOSURES:

The authors did not report any funding source or conflict of interests.

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 first appeared on Medscape.com.

LAS VEGAS — No matter which treatment regimen is recommended for patients with acne, it should always include a topical retinoid, according to dermatologist Hilary Baldwin, MD.

Patients with successfully treated acne typically use an average of 2.53 different medications, Baldwin, director of the Acne Treatment & Research Center, Brooklyn, New York, said at the Society of Dermatology Physician Associates (SDPA) 22nd Annual Fall Dermatology Conference.

 

“Combination treatment is the name of the game, but how do we convince our patients that what we chose is carefully orchestrated?” she said. “Combination therapy is much more effective, yet we’re always told, ‘keep it simple.’ The trick is to use combination products that have two or three medications in them — fixed combinations and products with excellent vehicles.”

No matter what treatment regimen is recommended for patients with acne, she continued, it should always include a topical retinoid. Tretinoin was the first topical retinoid approved for acne treatment in 1971, followed by adapalene in 1996, tazarotene in 1997, and trifarotene in 2019. According to a review article , topical retinoids inhibit the formation of microcomedones, reduce mature comedones and inflammatory lesions, enhance penetration of other drugs, reduce and prevent scarring, reduce hyperpigmentation, and maintain remission of acne.

More recently, authors of the 2024 American Academy of Dermatology guidelines of care for the management of acne vulgaris strongly recommended the use of topical retinoids based on moderate certainty evidence in the medial literature. Strong recommendations are also made for benzoyl peroxide, topical antibiotics, and oral doxycycline.

Baldwin noted that the benefits of retinoids include their comedolytic and anti-comedogenic properties, their effectiveness in treating inflammatory lesions, and their suitability for long-term maintenance. However, their drawbacks involve the potential for irritancy, which can be concentration- and vehicle-dependent.

Irritancy “maxes out at 1-2 weeks, but the problem is you lose the patient at 2 weeks unless they know it’s coming,” she said, noting that she once heard the 2-week mark characterized as a “crisis of confidence.” Patients “came in with a bunch of pimples, and now they’re red and flaky and burning and stinging [from the retinoid], yet they still have pimples,” Baldwin said. “You really need to talk them through that 2-week mark [or] they’re going to stop the medication.”

To improve retinoid tolerability, Baldwin offered the following tips:

• Use a pea-sized amount for the entire affected area and avoid spot treatments.
• Start with every other day application.
• Moisturize regularly, possibly applying moisturizer before the retinoid.
• Consider switching to a different formulation with an alternative vehicle or retinoid delivery system. Adapalene and tazarotene are the only retinoids that have proven to be stable in the presence of benzoyl peroxide, she said.
• Be persistent. “There is no such thing as a patient who cannot tolerate a retinoid,” said Baldwin, the lead author of a review on the evolution of topical retinoids for acne. “It’s because of a provider who failed to provide a sufficient amount of information to allow the patient to eventually be able to tolerate a retinoid.”

Baldwin also referred to an independent meta-analysis of 221 trials comparing the efficacy of pharmacological therapies for acne in patients of any age, which found that the percentage reduction in total lesion count, compared with placebo, was the highest with oral isotretinoin (mean difference [MD], 48.41; P = 1.00), followed by triple therapy containing a topical antibiotic, a topical retinoid, and benzoyl peroxide (MD, 38.15; P = .95), and by triple therapy containing an oral antibiotic, a topical retinoid, and benzoyl peroxide (MD, 34.83; P = .90).

Baldwin is a former president of the American Acne & Rosacea Society and is the SDPA conference medical director. She disclosed being a speaker, consultant, and/or an advisory board member for Almirall, Arcutis, Bausch, Beiersdorf, Cutera, Galderma, Journey, Kenvue, La Roche-Posay, L’Oreal, Sanofi, Sun Pharma, and Tarsus Pharmaceuticals.

 

A version of this article appeared on Medscape.com.

LAS VEGAS — No matter which treatment regimen is recommended for patients with acne, it should always include a topical retinoid, according to dermatologist Hilary Baldwin, MD.

Patients with successfully treated acne typically use an average of 2.53 different medications, Baldwin, director of the Acne Treatment & Research Center, Brooklyn, New York, said at the Society of Dermatology Physician Associates (SDPA) 22nd Annual Fall Dermatology Conference.

 

“Combination treatment is the name of the game, but how do we convince our patients that what we chose is carefully orchestrated?” she said. “Combination therapy is much more effective, yet we’re always told, ‘keep it simple.’ The trick is to use combination products that have two or three medications in them — fixed combinations and products with excellent vehicles.”

No matter what treatment regimen is recommended for patients with acne, she continued, it should always include a topical retinoid. Tretinoin was the first topical retinoid approved for acne treatment in 1971, followed by adapalene in 1996, tazarotene in 1997, and trifarotene in 2019. According to a review article , topical retinoids inhibit the formation of microcomedones, reduce mature comedones and inflammatory lesions, enhance penetration of other drugs, reduce and prevent scarring, reduce hyperpigmentation, and maintain remission of acne.

More recently, authors of the 2024 American Academy of Dermatology guidelines of care for the management of acne vulgaris strongly recommended the use of topical retinoids based on moderate certainty evidence in the medial literature. Strong recommendations are also made for benzoyl peroxide, topical antibiotics, and oral doxycycline.

Baldwin noted that the benefits of retinoids include their comedolytic and anti-comedogenic properties, their effectiveness in treating inflammatory lesions, and their suitability for long-term maintenance. However, their drawbacks involve the potential for irritancy, which can be concentration- and vehicle-dependent.

Irritancy “maxes out at 1-2 weeks, but the problem is you lose the patient at 2 weeks unless they know it’s coming,” she said, noting that she once heard the 2-week mark characterized as a “crisis of confidence.” Patients “came in with a bunch of pimples, and now they’re red and flaky and burning and stinging [from the retinoid], yet they still have pimples,” Baldwin said. “You really need to talk them through that 2-week mark [or] they’re going to stop the medication.”

To improve retinoid tolerability, Baldwin offered the following tips:

• Use a pea-sized amount for the entire affected area and avoid spot treatments.
• Start with every other day application.
• Moisturize regularly, possibly applying moisturizer before the retinoid.
• Consider switching to a different formulation with an alternative vehicle or retinoid delivery system. Adapalene and tazarotene are the only retinoids that have proven to be stable in the presence of benzoyl peroxide, she said.
• Be persistent. “There is no such thing as a patient who cannot tolerate a retinoid,” said Baldwin, the lead author of a review on the evolution of topical retinoids for acne. “It’s because of a provider who failed to provide a sufficient amount of information to allow the patient to eventually be able to tolerate a retinoid.”

Baldwin also referred to an independent meta-analysis of 221 trials comparing the efficacy of pharmacological therapies for acne in patients of any age, which found that the percentage reduction in total lesion count, compared with placebo, was the highest with oral isotretinoin (mean difference [MD], 48.41; P = 1.00), followed by triple therapy containing a topical antibiotic, a topical retinoid, and benzoyl peroxide (MD, 38.15; P = .95), and by triple therapy containing an oral antibiotic, a topical retinoid, and benzoyl peroxide (MD, 34.83; P = .90).

Baldwin is a former president of the American Acne & Rosacea Society and is the SDPA conference medical director. She disclosed being a speaker, consultant, and/or an advisory board member for Almirall, Arcutis, Bausch, Beiersdorf, Cutera, Galderma, Journey, Kenvue, La Roche-Posay, L’Oreal, Sanofi, Sun Pharma, and Tarsus Pharmaceuticals.

 

A version of this article appeared on Medscape.com.

LAS VEGAS — No matter which treatment regimen is recommended for patients with acne, it should always include a topical retinoid, according to dermatologist Hilary Baldwin, MD.

Patients with successfully treated acne typically use an average of 2.53 different medications, Baldwin, director of the Acne Treatment & Research Center, Brooklyn, New York, said at the Society of Dermatology Physician Associates (SDPA) 22nd Annual Fall Dermatology Conference.

 

“Combination treatment is the name of the game, but how do we convince our patients that what we chose is carefully orchestrated?” she said. “Combination therapy is much more effective, yet we’re always told, ‘keep it simple.’ The trick is to use combination products that have two or three medications in them — fixed combinations and products with excellent vehicles.”

No matter what treatment regimen is recommended for patients with acne, she continued, it should always include a topical retinoid. Tretinoin was the first topical retinoid approved for acne treatment in 1971, followed by adapalene in 1996, tazarotene in 1997, and trifarotene in 2019. According to a review article , topical retinoids inhibit the formation of microcomedones, reduce mature comedones and inflammatory lesions, enhance penetration of other drugs, reduce and prevent scarring, reduce hyperpigmentation, and maintain remission of acne.

More recently, authors of the 2024 American Academy of Dermatology guidelines of care for the management of acne vulgaris strongly recommended the use of topical retinoids based on moderate certainty evidence in the medial literature. Strong recommendations are also made for benzoyl peroxide, topical antibiotics, and oral doxycycline.

Baldwin noted that the benefits of retinoids include their comedolytic and anti-comedogenic properties, their effectiveness in treating inflammatory lesions, and their suitability for long-term maintenance. However, their drawbacks involve the potential for irritancy, which can be concentration- and vehicle-dependent.

Irritancy “maxes out at 1-2 weeks, but the problem is you lose the patient at 2 weeks unless they know it’s coming,” she said, noting that she once heard the 2-week mark characterized as a “crisis of confidence.” Patients “came in with a bunch of pimples, and now they’re red and flaky and burning and stinging [from the retinoid], yet they still have pimples,” Baldwin said. “You really need to talk them through that 2-week mark [or] they’re going to stop the medication.”

To improve retinoid tolerability, Baldwin offered the following tips:

• Use a pea-sized amount for the entire affected area and avoid spot treatments.
• Start with every other day application.
• Moisturize regularly, possibly applying moisturizer before the retinoid.
• Consider switching to a different formulation with an alternative vehicle or retinoid delivery system. Adapalene and tazarotene are the only retinoids that have proven to be stable in the presence of benzoyl peroxide, she said.
• Be persistent. “There is no such thing as a patient who cannot tolerate a retinoid,” said Baldwin, the lead author of a review on the evolution of topical retinoids for acne. “It’s because of a provider who failed to provide a sufficient amount of information to allow the patient to eventually be able to tolerate a retinoid.”

Baldwin also referred to an independent meta-analysis of 221 trials comparing the efficacy of pharmacological therapies for acne in patients of any age, which found that the percentage reduction in total lesion count, compared with placebo, was the highest with oral isotretinoin (mean difference [MD], 48.41; P = 1.00), followed by triple therapy containing a topical antibiotic, a topical retinoid, and benzoyl peroxide (MD, 38.15; P = .95), and by triple therapy containing an oral antibiotic, a topical retinoid, and benzoyl peroxide (MD, 34.83; P = .90).

Baldwin is a former president of the American Acne & Rosacea Society and is the SDPA conference medical director. She disclosed being a speaker, consultant, and/or an advisory board member for Almirall, Arcutis, Bausch, Beiersdorf, Cutera, Galderma, Journey, Kenvue, La Roche-Posay, L’Oreal, Sanofi, Sun Pharma, and Tarsus Pharmaceuticals.

 

A version of this article appeared on Medscape.com.