13882 Trifarotene 50 μg/g cream: An effective and safe treatment for moderate facial and truncal acne
Rosso JD, Tan J, Weiss JS, Gold LS, Cook-Bolden F, Eichenfield L, Tanghetti E, Graeber M, Saenz AA, and Ahmad F. 13882 Trifarotene 50 μg/g cream: An effective and safe treatment for moderate facial and truncal acne. Journal of the American Academy of Dermatology 2020; 83(6):AB14.
J Am Acad Dermatol
Introduction: While ∼50% of patients with facial acne have truncal acne, data concerning treatment of truncal acne has been lacking. Three recent studies evaluated the efficacy and safety of a new retinoid, trifarotene 50 μg/g cream (trifarotene), for facial and truncal acne. Methods: Two multicenter, randomized, double-blind, vehicle controlled, 12-week phase 3 studies (“Perfect” 1+2) and 1 multicenter, open-label, non-comparative 52-week study (“Satisfy”) investigated trifarotene once-daily in moderate facial and truncal acne. Efficacy end points included the Investigator’s Global Assessment (IGA 0-4, face), the Physician Global Assessment (PGA 0-4, trunk), and the change in facial/truncal inflammatory and noninflammatory lesions. Safety assessments included adverse events and local tolerance (erythema, scaling, dryness and stinging/burning). Results: The “Perfect” studies recruited 2420 subjects, and 1214 were treated with trifarotene. “Satisfy” enrolled 455 subjects, and 348 (76.5%) completed the 52-week study. All three studies met all efficacy end points, and both IGA and PGA successes (score 0-1, and 2-grade improvement) continued to increase throughout the full 52 weeks of the “Satisfy” study. There was a 29.4% IGA success rate with trifarotene compared with 19.5% for vehicle in “Perfect 1,” and 42.3% trifarotene IGA success rate compared with 25.7% for vehicle in “Perfect 2.” Signs/symptoms of local tolerability were mostly mild/moderate. Local irritation increased during week 1 on the face, up to week 2-4 on the trunk, decreasing thereafter, and was managed with moisturizers and/or regimen (application frequency) adjustment. Summary: Trifarotene was effective and safe in 3 phase 3 studies of moderate facial and truncal acne.