Conference Coverage

Trifarotene sails through 52-week acne trial


 

FROM AAD 2020

Trifarotene cream was effective and safe over one year for treatment of combined facial and truncal acne in a 52-week, multicenter, open-label study, James Q. Del Rosso, MD, reported at the virtual annual meeting of the American Academy of Dermatology.

The study is noteworthy because, even though roughly half of patients with facial acne also have truncal acne, there is actually very little clinical trial data on the treatment of truncal acne other than this new long-term study and the two earlier pivotal phase 3, 12-week trials which led to the October 2019 approval of trifarotene 50 mcg/g cream (Aklief) as the first novel retinoid for acne to reach the market in 20 years, observed Dr. Del Rosso, research director at JDR Research in Las Vegas and a member of the dermatology faculty at Touro University in Henderson, Nev.

The 52-week study, known as SATISFY, began with 454 patients with moderate facial and truncal acne who treated themselves with trifarotene once daily. Among the 348 patients who completed the full year, 67% achieved a score of 0 or 1 – clear or almost clear – with at least a 2-grade improvement from baseline by Investigator’s Global Assessment on their facial acne, and 65% met the same measure of success on the trunk. Moreover, 58% of patients met that standard at both acne sites.

The IGA success rate rose throughout the study period without ever reaching a plateau. However, it should be noted that 23% of participants dropped out of the study over the course of the year.

Mean tolerability scores reflecting redness, scaling, stinging or burning, and skin dryness remained well below the threshold for mild severity, peaking at weeks 2-4 of the study. The most common treatment-related adverse events were mild to moderate itching and irritation, each occurring in less than 5% of subjects.

Trifarotene is a first-in-class retinoid that specifically targets the retinoic acid receptor gamma, the most common cutaneous retinoic acid receptor.

Dr. Del Rosso reported serving as an investigator and consultant for Galderma, which sponsored the study and markets trifarotene cream.

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