Document Type
Article
Publication Date
6-1-2019
Abstract
BACKGROUND: Acne vulgaris often affects the face, shoulders, chest, and back, but treatment of nonfacial acne has not been rigorously studied.
OBJECTIVES: Assess the safety and 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 versus vehicle in subjects aged 9 years or older. The primary end points were rate of success on the face, as determined by the Investigator's Global Assessment (clear or almost clear and ≥2-grade improvement), and absolute change from baseline in inflammatory and noninflammatory counts from baseline to week 12. The secondary end points were rate of success on the trunk (clear or almost clear and ≥2-grade improvement) and absolute change in truncal inflammatory and noninflammatory counts from baseline to week 12. Safety was assessed through adverse events, local tolerability, vital signs, and routine laboratory testing results.
RESULTS: In both studies, at week 12 the facial success rates according to the Investigator's Global Assessment and truncal Physician's Global Assessment and change in inflammatory and noninflammatory lesion counts (both absolute and percentage) were all highly significant (P < .001) in favor of trifarotene when compared with the vehicle.
LIMITATIONS: Adjunctive topical or systemic treatments were not studied.
CONCLUSION: These studies demonstrate that trifarotene appears to be safe, effective, and well tolerated in treatment of both facial and truncal acne.
Recommended Citation
Tan, Jerry; Thiboutot, Diane; Popp, Georg; Gooderham, Melinda; Lynde, Charles; Del Rosso, James; Weiss, Jonathan; Blume-Peytavi, Ulrike; Weglovska, Jolanta; Johnson, Sandra; Parish, Lawrence; Witkowska, Dagmara; Sanchez Colon, Nestor; Alió Saenz, Alessandra; Ahmad, Faiz; Graeber, Michael; and Stein Gold, Linda, "Randomized phase 3 evaluation of trifarotene 50 μg/g cream treatment of moderate facial and truncal acne." (2019). Department of Dermatology and Cutaneous Biology Faculty Papers. Paper 112.
https://jdc.jefferson.edu/dcbfp/112
Creative Commons License
This work is licensed under a Creative Commons Attribution-Noncommercial-No Derivative Works 4.0 License.
PubMed ID
30802558
Language
English
Comments
This article has been peer reviewed. It is the author’s final published version in Journal of the American Academy of Dermatology, Volume 80, Issue 6, June 2019, Pages 1691-1699.
The published version is available at https://doi.org/10.1016/j.jaad.2019.02.044. Copyright © Tan et al.