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Efficacy of Topical Acne Therapy May Be Impacted by Sex

Tretinoin 0.05% lotion is effective and tolerated in all patients with moderate to severe acne, according to the findings of a recent study; however, the topical therapy is more effective in women compared with men.

Interest in racial and gender differences in the pathogenesis and treatment of acne has increased, the researchers noted. Postinflammatory hyperpigmentation is a major concern among patients with skin of color. Female acne patients report more anxiety and depression with acne and have different presentations compared with their male counterparts, they added.

In the post hoc analysis, the researchers analyzed data from 2 multicenter, randomized, vehicle-controlled phase 3 studies to assess the safety and efficacy of tretinoin 0.05% lotion among patients with moderate to severe acne. A total of 1640 participants were randomized in the study to either once daily tretinoin 0.05% lotion or vehicle for 12 weeks.
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Efficacy was based on changes in baseline inflammatory and noninflammatory lesions and treatment success, which was defined as an at least 2-grade reduction in Evaluator Global Severity Score. At each study visit, the researchers evaluated quality of life (QoL) using the Acne QoL scale, safety, adverse events, cutaneous tolerability, and hypo- and hyperpigmentation. Data were stratified based on race and sex.

At week 12, the mean percent reduction in inflammatory lesion counts was 56.9% among female participants and 53.4% among male participants treated with tretinoin 0.05% compared with 47.1% and 39.4% among female and male participants in the vehicle group, respectively. The mean percent reduction in inflammatory lesion counts was statistically significant among women compared with men after 8 weeks of treatment with tretinoin 0.05% lotion, the researchers observed.

Likewise, the mean percent reduction in noninflammatory lesion counts was statistically significant among women compared with men at week 12. The reductions were 51.7% and 46.1% among women and men, respectively, in the tretinoin group compared with 34.9% and 29.7% among women and men in the vehicle group.

At week 12, treatment success was achieved by 23.6% of women and 16.1% of men treated with 0.05% lotion, the researchers said, with statistical significance observed among women compared with men.

In addition, significant differences in inflammatory lesion count reductions were reported among Caucasian participants at week 8 and Black African/American male participants at week 12, the researchers said. They found that only male participants reported significant differences in both races in terms of noninflammatory lesions, while only Caucasian participants reported significant differences in treatment success.

Compared with vehicle, female participants treated with tretinoin 0.05% lotion had statistically significant improvements in each Acne QoL domain. Among male participants, improvements in QoL were only statistically different for acne symptoms, the researchers observed.

While more treatment-related adverse events occurred in the female subpopulation, with significantly greater incidence of skin dryness that was more common in younger Caucasian females, tretinoin 0.05% lotion was well-tolerated in both genders.

“Tretinoin 0.05% lotion has been shown to be effective and well-tolerated in moderate to severe acne. Treatment was significantly more effective in females than males,” the researchers concluded. “Tretinoin 0.05% lotion was well tolerated by both genders, although there was a higher incidence of treatment-related adverse events, especially skin dryness, in females.”

“There were racial and gender differences in QoL and beneficial effects on PIH in those patients most at risk,” they added.


Lain E, Day D, Harper J, Guenin E. Tretinoin 0.05% lotion for the once-daily treatment of moderate-to-severe acne vulgaris: Impact of gender and race on efficacy and safety. J Drugs Dermatol. 2019;18(11): 1128-1138.

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