James Q Del Rosso1, Sandra Marchese Johnson2, Todd Schlesinger3, Lawrence Green4, Nestor Sanchez5, Edward Lain6, Zoe Draelos7, Jean-Philippe York8, Rajeev Chavda9. 1. Dr. Del Rosso is with JDR Dermatology Research in Las Vegas, Nevada and Advanced Dermatology and Cosmetic Surgery Clinical Research in Maitland. Florida. 2. Dr. Johnson is with Johnson Dermatology in Fort Smith, Arkansas. 3. Dr. Schlesinger is with the Clinical Research Center of the Carolinas in Charleston, South Carolina. 4. Dr. Green is with the George Washington School of Medicine in Washington D.C. 5. Dr. Sanchez is with Dermatology and Pathology, at Aibonito Hospital in Aibonito, Puerto Rico. 6. Dr. Lain is with the Austin Institute for Clinical Research in Austin, Texas. 7. Dr. Draelos is with Dermatology Consulting Services, PLLC in High Point, North Carolina. 8. Dr. York is with Galderma Laboratories, LP in Fort Worth, Texas, and Galderma SA in Switzerland. 9. Dr. Chavda is with Galderma SA in Switzerland.
Abstract
Objective: We evaluated the efficacy and safety of trifarotene plus oral doxycycline in acne. Methods: This was a randomized (2:1 ratio) 12-week, double-blind study of once-daily trifarotene cream 50µg/g plus enteric-coated doxycycline 120mg (T+D) versus trifarotene vehicle and doxycycline placebo (V+P). Patients were aged 12 years or older with severe facial acne (≥20 inflammatory lesions, 30 to 120 non-inflammatory lesions, and ≤4 nodules). Efficacy outcomes included change from baseline in lesion counts and success (score of 0/1 with ≥2 grade improvement) on investigator global assessment (IGA). Safety was assessed by adverse events and local tolerability. Results: The study enrolled 133 subjects in the T+D group and 69 subjects in the V+P group. The population was balanced, with an approximately even ratio of adolescent (12-17 years) and adult (≥18 years) subjects. The absolute change in lesion counts from baseline were: -69.1 T+D versus -48.1 V+P for total lesions, -29.4 T+D versus -19.5 V+P for inflammatory lesions, and -39.5 T+D versus -28.2 for non-inflammatory lesions (P<0.0001 for all). Success was achieved by 31.7 percent of subjects in the T+D group versus 15.8 percent in the V+P group (P=0.0107). The safety and tolerability profiles were comparable between the T+D and V+P arms. Conclusion: T+D was demonstrated to be safe and efficacious as a treatment option for patients with severe acne.
Objective: We evaluated the efficacy and safety of trifarotene plus oral doxycycline in acne. Methods: This was a randomized (2:1 ratio) 12-week, double-blind study of once-daily trifarotene cream 50µg/g plus enteric-coated doxycycline 120mg (T+D) versus trifarotene vehicle and doxycycline placebo (V+P). Patients were aged 12 years or older with severe facial acne (≥20 inflammatory lesions, 30 to 120 non-inflammatory lesions, and ≤4 nodules). Efficacy outcomes included change from baseline in lesion counts and success (score of 0/1 with ≥2 grade improvement) on investigator global assessment (IGA). Safety was assessed by adverse events and local tolerability. Results: The study enrolled 133 subjects in the T+D group and 69 subjects in the V+P group. The population was balanced, with an approximately even ratio of adolescent (12-17 years) and adult (≥18 years) subjects. The absolute change in lesion counts from baseline were: -69.1 T+D versus -48.1 V+P for total lesions, -29.4 T+D versus -19.5 V+P for inflammatory lesions, and -39.5 T+D versus -28.2 for non-inflammatory lesions (P<0.0001 for all). Success was achieved by 31.7 percent of subjects in the T+D group versus 15.8 percent in the V+P group (P=0.0107). The safety and tolerability profiles were comparable between the T+D and V+P arms. Conclusion: T+D was demonstrated to be safe and efficacious as a treatment option for patients with severe acne.
Authors: 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 Journal: J Am Acad Dermatol Date: 2019-02-22 Impact factor: 11.527
Authors: Andrea L Zaenglein; Arun L Pathy; Bethanee J Schlosser; Ali Alikhan; Hilary E Baldwin; Diane S Berson; Whitney P Bowe; Emmy M Graber; Julie C Harper; Sewon Kang; Jonette E Keri; James J Leyden; Rachel V Reynolds; Nanette B Silverberg; Linda F Stein Gold; Megha M Tollefson; Jonathan S Weiss; Nancy C Dolan; Andrew A Sagan; Mackenzie Stern; Kevin M Boyer; Reva Bhushan Journal: J Am Acad Dermatol Date: 2016-02-17 Impact factor: 11.527
Authors: Jerry Tan; Stefan Beissert; Fran Cook-Bolden; Rajeev Chavda; Julie Harper; Adelaide Hebert; Edward Lain; Alison Layton; Marco Rocha; Jonathan Weiss; Brigitte Dréno Journal: JAAD Int Date: 2021-04-27