Long‐term safety and efficacy of trifarotene 50 μg/g cream, a first‐in‐class RAR‐γ selective topical retinoid, in patients with moderate facial and truncal acne

Background Treatment for both facial and truncal acne has not sufficiently been studied. Objectives To evaluate the long‐term safety and efficacy of trifarotene in both facial and truncal acne. Methods In a multicentre, open‐label, 52‐week study, patients with moderate facial and truncal acne received trifarotene 50 μg/g cream (trifarotene). Assessments included local tolerability, safety, investigator and physician's global assessments (IGA, PGA) and quality of life (QOL). A validated QOL questionnaire was completed by the patient at Baseline, Week 12, 26 and 52/ET. Results Of 453 patients enrolled, 342 (75.5%) completed the study. Trifarotene‐related treatment‐emergent adverse events (TEAEs) were reported in 12.6% of patients, and none was serious. Most related TEAEs were cutaneous and occurred during the first 3 months. Signs and symptoms of local tolerability were mostly mild or moderate and severe signs, and symptoms were reported for 2.2% to 7.1% of patients for the face and 2.5% to 5.4% for the trunk. Local irritation increased during the first week of treatment on the face and up to Weeks 2 to 4 on the trunk with both decreasing thereafter. At Week 12, IGA and PGA success rates were 26.6% and 38.6%, respectively. Success rates increased to 65.1% and 66.9%, respectively at Week 52. Overall success (both IGA and PGA success in the same patient) was 57.9% at Week 52. At Week 52 visit, 92/171 (53.8%) patients who had completed their assessments had scores from 0 to 1 (i.e. no effect of acne on their QOL) vs. 47/208 (22.6%) patients at Baseline visit. Conclusion In this 52‐week study, trifarotene was safe, well tolerated and effective in moderate facial and truncal acne.