Tretinoin gel microspheres 0.04% versus 0.1% in adolescents and adults with mild to moderate acne vulgaris: A 12-week, multicenter, randomized, double-blind, parallel-group, phase IV trial

摘要: Abstract Background: Topical retinoids are considered first-line therapy in the treatment of acne vulgaris, yet can be associated with cutaneous irritation, including erythema, peeling, dryness, burning, and itching. Tretinoin gel microsphere (TGM) formulations were developed to minimize these effects. A lower-strength TGM formulation may desirable further reduce exposure tretinoin. Objective: This study was conducted assess efficacy safety profile a lower-dose (0.04%) compared 0.1% for mild moderate vulgaris. Methods: In this multicenter, double-blind, parallel-group, Phase IV dose-ranging study, patients facial randomized apply either 0.04% or face each night 12 weeks. Patients must have discontinued systemic retinoid at least 1 year before not used any topical retinoids, antibiotics, nicotinamide, steroids month. All other medications applied (including corticosteroids, antimicrobials, salicylic acid, benzoyl peroxide) 2 weeks study. End points lesion count (total, inflammatory, noninflammatory lesions) investigators' patients' assessments improvement. Adverse events severity relationship treatment) signs symptoms irritation site monitored visit. Results: One hundred fifty-six (78 0.04%, 78 0.1%) received treatment. ranged age from 41 years (mean, 18.4 years) predominantly white (n = 89 [57.1%]) male 80 [51.3%]). Both reduction baseline total, lesions. The differences between groups change counts 2, 4, 8, statistically significant. However, there greater inflammatory lesions week (14.8% vs 6.0%, respectively; P 0.035). Conclusions: reductions acne. concentrations generally well tolerated. results suggested an early (week 2) incremental benefit use