Sun Pharmaceutical Industries presented a systematic review and meta-analysis at the 2024 Fall Clinical Dermatology Conference, comparing the efficacy of clascoterone (Winlevi; Sun Pharma), trifarotene (Aklief; Galderma), and tazarotene (Arazlo; Ortho Dermatologics) in treating moderate to severe acne vulgaris after 12 weeks of treatment. The findings suggest that all three agents exhibit comparable efficacy in reducing acne lesions.
Study Design and Methods
Researchers conducted a systematic literature review, searching Embase and MEDLINE databases for relevant randomized controlled trials (RCTs) published up to October 2023. The review focused on studies comparing clascoterone cream (1%), trifarotene cream (0.005%), and tazarotene lotion (0.045%) against placebo. The primary outcomes assessed were the mean percent reduction in inflammatory lesion count (ILC), the mean percent reduction in non-inflammatory lesion count (NILC), and the percentage of patients achieving treatment success at 12 weeks.
The systematic review identified six phase 3 RCTs, encompassing a total of 5,474 patients. Among these, 2,735 patients were randomized to receive active treatment (clascoterone: 722 patients; trifarotene: 1,214 patients; tazarotene: 799 patients), while 2,739 were assigned to vehicle treatment.
Key Findings
The trials demonstrated that all three agents significantly reduced both inflammatory and non-inflammatory lesion counts compared to placebo. The meta-analysis revealed no statistically significant differences in efficacy among the three treatments. The mean percent reduction in ILC and NILC, as well as the rates of treatment success, were comparable across clascoterone, trifarotene, and tazarotene.
The odds ratios for treatment success indicated that clascoterone had an OR of 2.90 (95% CI: 1.82, 4.61), trifarotene had an OR of 1.92 (95% CI: 1.57, 2.36), and tazarotene had an OR of 2.13 (95% CI: 1.67, 2.73). These findings suggest similar efficacy profiles in reducing acne lesions among the three agents.
Clinical Implications
According to the poster authors, the lack of significant differences in efficacy among clascoterone, trifarotene, and tazarotene suggests that clinicians may choose any of these agents based on individual patient needs, preferences, and potential side effects. However, the authors noted that the study primarily focused on efficacy, and safety profiles were not assessed in detail.
Future Research
"Additional comparisons of safety outcomes between these agents will be important to determine if significant differences exist and to inform treatment decisions in clinical settings," the authors wrote. Further research should focus on comparing the safety profiles of these agents to provide a more comprehensive understanding of their clinical utility.
