Phase 3 Study Comparing Trifarotene 50 mcgg Cream to Vehicle Cream for Moderate Acne in Chinese Participants Aged 9 Years and Older

What this Trial Is About

Researchers are evaluating the effectiveness of trifarotene 50 microgram per gram cream compared to a vehicle cream in treating moderate acne vulgaris on the face and trunk in Chinese participants. This phase 3, randomized, double-blind, vehicle-controlled study aims to understand how well trifarotene works when applied once daily over 12 weeks in this population. Participants will be randomly assigned to apply either trifarotene cream or vehicle cream once daily in the evening for 12 weeks. The study includes two groups one receiving the active trifarotene cream and the other receiving the vehicle cream, both applied topically. This treatment period is the main phase of the trial where efficacy and safety are monitored. During the study, participants will attend visits to assess acne severity and lesion counts on the face and trunk, using Investigator Global Assessment IGA and Physician Global Assessment PGA scales. Researchers will track changes in inflammatory and non-inflammatory lesions from baseline to week 12, monitor adverse events, and evaluate skin tolerability at several points. Some participants will have plasma samples collected to measure drug levels. The total participation lasts 12 weeks with monitoring throughout this period.

A Study to Compare the Efficacy, Safety and Pharmacokinetics of Trifarotene 50 mcg/g Cream in Chinese Subjects With Acne Vulgaris