53447 Phase IV studies show trifarotene is efficacious and suitable for broad range of patient types
Recommended Citation
Alexis A, Stein-Gold L, Chavda R, York JP, Del Rosso J, Weiss J. 53447 Phase IV studies show trifarotene is efficacious and suitable for broad range of patient types. J Am Acad Dermatol 2024; 91(3):AB70.
Document Type
Conference Proceeding
Publication Date
9-1-2024
Publication Title
J Am Acad Dermatol
Abstract
Background: Acne is highly visible andone of the most common skin diseases. Healthcare professionals should have a reliable first-line approach that is efficacious and suited for a broad range of patient skin types, ages, and demographics. Methods: Including the Phase 3 program, trifarotene has been studied in thousands of acne subjects in clinical trials. Most recently two vehicle-controlled, 24-week phase 4 studies evaluated trifarotene treatment of acne and 1) atrophic acne scarring (4-1) and 2) acne-related hyperpigmentation (4-2). The scarring study 4-1) utilized a split-face design (N = 121) while the pigmentation study (Phase4-2) randomized subjects 1:1 to active or vehicle arms (N = 123). Results: The studies were international, with men and women in the studies ranging from 9 to 58 years of age. The phase 3 studies were majority White, but included substantial diversity, including 74 Black/African-American and 195 Latino subjects treated with trifarotene. In 4-2 <50% of subjects were White. Additionally, 30.6% of subjects in 4-1 and 61.7% of subjects in 4-2 had type IV-VI skin. Approximately 35% of subjects in 4-1 and 2 identified as Hispanic/Latino. In Study 2, 18.2% of subjects in the trifarotene group were Asian. In all studies, trifarotene was significantly superior to vehicle in improving acne. In 4-1, trifarotene rapidly improved atrophic acne scars and in 4-2 trifarotene reduced hyperpigmentation. In all studies, trifarotene had a positive risk/benefit ratio. Conclusions: Across a broad range of subject types, trifarotene had good efficacy for improving acne, atrophic scars, and hyperpigmentation, and safety.
Volume
91
Issue
3
First Page
AB70
