Jerry Tan1, Diane Thiboutot2, Georg Popp3, Melinda Gooderham4, Charles Lynde5, James Del Rosso6, Jonathan Weiss7, Ulrike Blume-Peytavi8, Jolanta Weglovska9, Sandra Johnson10, Lawrence Parish11, Dagmara Witkowska12, Nestor Sanchez Colon13, Alessandra Alió Saenz14, Faiz Ahmad15, Michael Graeber15, Linda Stein Gold16. 1. Department of Medicine, University of Western Ontario, Windsor, Ontario, Canada. 2. Penn State Hershey Medical Center and Penn State College of Medicine, Hershey, Pennsylvania, USA. 3. Licca Clinical Research Institute, Augsburg, Germany. 4. SKIN Centre for Dermatology and SKIN Laser Clinic, Peterborough, Ontario, Canada. 5. Lynde Institute for Dermatology, Markham, Ontario, Canada. 6. JDR Dermatology Research/Thomas Dermatology, Las Vegas, Nevada, USA. 7. Gwinnett Dermatology, PC, and Gwinnett Clinical Research Center, INC, Snellville, Georgia, USA. 8. Department of Dermatology and Allergy, Charité Universitätsmedizin, Berlin, Germany. 9. Niepubliczny Zakład Opieki Zdrowotnej multiMedica, Wrocław, Poland. 10. Johnson Dermatology, Fort Smith, Arkansas, USA. 11. Department of Dermatology and Cutaneous Biology and the Jefferson Center for International Dermatology, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, Pennsylvania, USA. 12. DermMedica Sp, Wrocław, Poland. 13. University of Puerto Rico, School of Medicine, San Juan, Puerto Rico. 14. Galderma R&D LLC, Fort Worth, Texas, USA. Electronic address: alessandra.alio@galderma.com. 15. Galderma R&D LLC, Fort Worth, Texas, USA. 16. Henry Ford Medical Center, Department of Dermatology, Detroit, Michigan, USA.
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.
RCT Entities:
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.
Authors: Hilary Baldwin; Guy Webster; Linda Stein Gold; Valerie Callender; Fran E Cook-Bolden; Eric Guenin Journal: Am J Clin Dermatol Date: 2021-05 Impact factor: 7.403
Authors: U Blume-Peytavi; J Fowler; L Kemény; Z Draelos; F Cook-Bolden; T Dirschka; L Eichenfield; M Graeber; F Ahmad; A Alió Saenz; P Rich; E Tanghetti Journal: J Eur Acad Dermatol Venereol Date: 2019-08-20 Impact factor: 6.166
Authors: Terenzio Cosio; Monia Di Prete; Roberta Gaziano; Caterina Lanna; Augusto Orlandi; Paolo Di Francesco; Luca Bianchi; Elena Campione Journal: Biomedicines Date: 2021-02-26