Randomized Phase 3 Evaluation of Trifarotene 50 μG/G Cream Treatment Of Moderate Facial And Truncal ACNE

Publication date: Available online 22 February 2019

Source: Journal of the American Academy of Dermatology

Author(s): Jerry Tan, Diane Thiboutot, Georg Popp, Melinda Gooderham, Charles Lynde, James Del Rosso, Jonathan Weiss, Ulrike Blume-Peytavi, Jolanta Weglovska, Sandra Johnson, Lawrence Parish, Dagmara Witkowska, Nestor Sanchez Colon, Alessandra Alió Saenz, Faiz Ahmad, Michael Graeber, Linda Stein Gold

Abstract

Background

Acne vulgaris often affects the face, shoulders, chest, and back but treatment of non-facial acne has not been rigorously studied.

Objectives

Assess the safety/efficacy of trifarotene 50 μg/g cream, a novel topical retinoid, in moderate facial and truncal acne.

Methods

Two phase III double-blind, randomized, vehicle-controlled, 12-week studies of once-daily trifarotene cream vs vehicle in subjects aged ≥9 years. Primary endpoints were success rate on face Investigator Global Assessment (IGA, clear/almost clear and ≥2 grade improvement) and absolute change from baseline in inflammatory/non-inflammatory counts from baseline to week 12. Secondary endpoints were success rate on trunk (clear/almost clear and ≥2 grade improvement) and absolute change in truncal inflammatory/non-inflammatory counts from baseline to week 12. Safety was assessed through adverse events, local tolerability, vital signs, and routine laboratory testing.

Results

In both studies, at Week 12, facial (IGA) and truncal (PGA) success rates and change in inflammatory and non-inflammatory lesion counts (both absolute and %) were all highly significant (p<0.001) in favor of trifarotene compared to the vehicle.

Limitations

Adjunctive topical or systemic treatments were not studied.

Conclusion

These studies demonstrate that trifarotene appears to be safe, efficacious and well-tolerated in treatment of both facial and truncal acne.

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