Marge Nighland1, Rachel Grossman. 1. Johnson & Johnson Consumer and Personal Products Worldwide, Skillman, NJ 08558-9418, USA. mnighla@cpcus.njn.com
Abstract
BACKGROUND: Acne vulgaris can persist beyond adolescence into the fourth decade of life or later; most patients have a combination of inflammatory and noninflammatory lesions. OBJECTIVE: To determine whether tretinoin microsphere gel (TMG) 0.04% applied once nightly is well tolerated and effective in reducing inflammatory and noninflammatory lesions in adolescents and adults with mild to moderate facial acne. METHODS: The results of 3 randomized, double-blind, vehicle-controlled studies of TMG 0.04% applied once nightly for 12 consecutive weeks in a total of 629 patients, ages 11 to 49 years, were combined. Reductions in acne lesion counts were assessed twice monthly, and an investigator's global evaluation (IGE) was performed at the study endpoint (week 12). RESULTS:Tretinoin microsphere gel 0.04% was significantly superior to the vehicle gel in reducing both inflammatory and noninflammatory lesions over the 12-week treatment period, and produced a higher successful treatment rate than the vehicle gel, as judged by IGE ratings at week 12. The most frequent adverse events were erythema, peeling, and dryness, which were mostly mild and occurred in 59.7% to 63.3% of patients with TMG 0.04%, as compared with 26.9% to 51.0% of patients with the vehicle gel (placebo). CONCLUSION: The TMG 0.04% formulation is significantly superior when compared to its vehicle gel in reducing inflammatory and noninflammatory acne lesions over a period of 12 weeks and is well tolerated.
RCT Entities:
BACKGROUND: Acne vulgaris can persist beyond adolescence into the fourth decade of life or later; most patients have a combination of inflammatory and noninflammatory lesions. OBJECTIVE: To determine whether tretinoin microsphere gel (TMG) 0.04% applied once nightly is well tolerated and effective in reducing inflammatory and noninflammatory lesions in adolescents and adults with mild to moderate facial acne. METHODS: The results of 3 randomized, double-blind, vehicle-controlled studies of TMG 0.04% applied once nightly for 12 consecutive weeks in a total of 629 patients, ages 11 to 49 years, were combined. Reductions in acne lesion counts were assessed twice monthly, and an investigator's global evaluation (IGE) was performed at the study endpoint (week 12). RESULTS:Tretinoin microsphere gel 0.04% was significantly superior to the vehicle gel in reducing both inflammatory and noninflammatory lesions over the 12-week treatment period, and produced a higher successful treatment rate than the vehicle gel, as judged by IGE ratings at week 12. The most frequent adverse events were erythema, peeling, and dryness, which were mostly mild and occurred in 59.7% to 63.3% of patients with TMG 0.04%, as compared with 26.9% to 51.0% of patients with the vehicle gel (placebo). CONCLUSION: The TMG 0.04% formulation is significantly superior when compared to its vehicle gel in reducing inflammatory and noninflammatory acne lesions over a period of 12 weeks and is well tolerated.
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: Gemma Latter; Jeffrey E Grice; Yousuf Mohammed; Michael S Roberts; Heather A E Benson Journal: Pharmaceutics Date: 2019-09-24 Impact factor: 6.321