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Trifarotene cream proven safe, effective in treatment of moderate facial, truncal acne

Stephen Padilla
24 Jun 2019

Two independent, phase III studies (PERFECT 1 and 2) have shown the efficacy and safety of trifarotene 50-μg/g cream in the treatment of moderate acne on the face and trunk.

“Trifarotene exhibited the expected local tolerability profile of a topical retinoid,” researchers said. “In both studies, the local tolerability profile of trifarotene was mostly mild or moderate and manageable when it was applied to the face as well as to the larger body surface areas of the trunk.”

At week 12, both studies showed highly significant facial success rates for trifarotene (PERFECT 1: Investigator’s Global Assessment [IGA], 29.4 percent; PERFECT 2: IGA, 42.3 percent) as compared with the vehicle (PERFECT 1: IGA, 19.5 percent; PERFECT 2: IGA, 25.7 percent; p<0.001). [J Am Acad Dermatol 2019;80:1691-1699]

Trifarotene also showed statistically significant superior success rates at week 4 (PERFECT 1) and week 8 (PERFECT 2) relative to the vehicle.

Moreover, there were significantly superior reductions in facial lesion counts with trifarotene vs the vehicle, with statistical difference seen as early as weeks 2 and 1. The corresponding mean absolute inflammatory lesion counts with trifarotene decreased by 19.0 and 24.2 as opposed to 15.4 and 18.7 with the vehicle (p<0.001). The respective mean absolute noninflammatory lesion counts with trifarotene decreased by 25.0 and 30.1 vs 17.9 and 21.6 with the vehicle (p<0.001).

“Few studies have evaluated drugs in the treatment of truncal acne, and there are no well-designed comparative studies,” researchers claimed. “Most studies have been small in scale and not rigorously controlled.” [http://practicaldermatology.com/2010/02/back-in-the-spotlight-effective-options-for-truncal-acne; Cutis 2006;77:285-289]

In a review of the evidence of treatment outcomes of acne located in different anatomic regions, there were varying responses to systemic therapy when the face and trunk are involved. [Tsatsou F, Zouboulis CC. In: Zouboulis A, Katsambas AM, Kligman, eds. Pathogenesis and Treatment of Acne and Rosacea. Springer: London, 2014.]

Furthermore, trifarotene had a rapid onset of effect compared with the vehicle, with significant reductions in both inflammatory and noninflammatory lesion counts seen as early as 1 week after treatment on the face and as early as 2 weeks after treatment on the trunk.

“This observation is consistent with the findings of a 12-month, long-term safety study of trifarotene 50 μg/g cream, in which the success rate for the face and trunk demonstrated a consistent continuous clinical improvement over time and within the same subject,” researchers said. [Blume-Peytavi UF, et al. Long-term safety and efficacy of trifarotene 50 g/g cream, a first-in-class RAR gamma selective topical retinoid, in subjects with moderate facial and truncal acne. J Eur Acad Dermatol Venereol. In press]

The two phase III double-blind, randomized, vehicle-controlled, 12-week studies of once-daily trifarotene cream vs vehicle included patients aged 9 years. The primary endpoints were success rate on the face and absolute change from baseline in inflammatory and noninflammatory counts from baseline to week 12, while secondary endpoints were success rate on the trunk and absolute change in truncal inflammatory and noninflammatory counts from baseline to week 12.

Researchers assessed safety through adverse events, local tolerability, vital signs and routine laboratory testing results. Adjunctive topical or systemic treatments, however, were not included in the analysis.

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