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Journal of the American Academy of Dermatology
Volume 80, n° 6
pages 1691-1699 (juin 2019)
Doi : 10.1016/j.jaad.2019.02.044
accepted : 19 February 2019
Original Articles

Randomized phase 3 evaluation of trifarotene 50 μg/g cream treatment of moderate facial and truncal acne
 

Jerry Tan, MD a, Diane Thiboutot, MD b, Georg Popp, MD c, Melinda Gooderham, MD d, Charles Lynde, MD e, James Del Rosso, DO f, Jonathan Weiss, MD g, Ulrike Blume-Peytavi, MD h, Jolanta Weglovska, MD i, Sandra Johnson, MD j, Lawrence Parish, MD k, Dagmara Witkowska, MD l, Nestor Sanchez Colon, MD m, Alessandra Alió Saenz, MD n, , Faiz Ahmad, MS n, Michael Graeber, MD n, Linda Stein Gold, MD o
a Department of Medicine, University of Western Ontario, Windsor, Ontario, Canada 
b Penn State Hershey Medical Center and Penn State College of Medicine, Hershey, Pennsylvania, USA 
c Licca Clinical Research Institute, Augsburg, Germany 
d SKIN Centre for Dermatology and SKIN Laser Clinic, Peterborough, Ontario, Canada 
e Lynde Institute for Dermatology, Markham, Ontario, Canada 
f JDR Dermatology Research/Thomas Dermatology, Las Vegas, Nevada, USA 
g Gwinnett Dermatology, PC, and Gwinnett Clinical Research Center, INC, Snellville, Georgia, USA 
h Department of Dermatology and Allergy, Charité Universitätsmedizin, Berlin, Germany 
i Niepubliczny Zakład Opieki Zdrowotnej multiMedica, Wrocław, Poland 
j Johnson Dermatology, Fort Smith, Arkansas, USA 
k Department of Dermatology and Cutaneous Biology and the Jefferson Center for International Dermatology, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, Pennsylvania, USA 
l DermMedica Sp, Wrocław, Poland 
m University of Puerto Rico, School of Medicine, San Juan, Puerto Rico 
n Galderma R&D LLC, Fort Worth, Texas, USA 
o Henry Ford Medical Center, Department of Dermatology, Detroit, Michigan, USA 

Correspondence to: Alessandra Alió Saenz, MD, Galderma Laboratories, LLP, 14501 N Freeway Service Road E, Fort Worth, TX 76177.Galderma LaboratoriesLLP14501 N Freeway Service Road EFort WorthTX76177
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.

The full text of this article is available in PDF format.

Key words : acne vulgaris, phase 3 trial, pivotal trials, trifarotene, truncal acne

Abbreviations used : AE, AV, IGA, PGA, RAR, RARγ, TEAE



 Funding sources: Supported by Nestle Skin Health Care- Galderma R&D, LLC, Fort Worth, Texas, USA.
 Disclosure: Dr Tan has served as a consultant, speaker, and investigator for Galderma. Dr Thiboutot has served as an investigator and consultant for Galderma, Dermik, Novan, Cassiopea, Novartis, and Botanix. Dr Popp, Dr Gooderham, Dr Weiss, Dr Sanchez Colon, Dr Witkowska, and Dr Parish have served as investigators for Galderma. Dr Del Rosso and Dr Johnson have served as investigators, consultants, and speakers for Galderma. Dr Lynde has served as consultant, speaker, and investigator and has participated in advisory boards for Valeant Pharma and Galderma; in addition, he has served as an investigator for Xenon and Demira. Dr Blume-Peytavi has received honoraria for lectures from Nestlé Skin Health–Galderma and has received fees for the conduct of clinical studies. Dr Weglovska has served as an advisory board member and investigator for Galderma and has served as a consultant and investigator for Dermira, Regeneron, UCB, Leo Pharma, Mercu, and Amgen. Dr Stein Gold has served as an investigator, advisor, and speaker for Galderma, Valeant, Novartis, and Allergan and as an investigator and advisor for Derma; in addition, she has also served as an investigator for Novan and Cassiopea. Dr Graeber, Mr Ahmad, and Dr Alió Saenz are employees of Galderma Research and Development LLC.



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