Novel Tretinoin 0.05% Lotion for the Once-daily Treatment of Moderate-to-severe Acne Vulgaris in a Preadolescent and Adolescent Population

摘要

Background: The efficacy of tretinoin is well documented in adolescent acne, with limited data available in preadolescents. A novel tretinoin 0.05% lotion formulation has been shown to be effective and well tolerated in moderate-to-severe acne. Objective: We sought to evaluate the safety and efficacy of tretinoin 0.05% lotion in preadolescent (≤13 years) and adolescent (14–17 years) subjects with acne. Methods: This study involved the post-hoc analysis of two multicenter, randomized, double-blind, vehicle-controlled Phase III studies. Preadolescent (n=154) and adolescent (n=575) subjects were randomized (1:1) to tretinoin 0.05% lotion or vehicle used once daily for 12 weeks. Efficacy assessments included lesion count reductions, treatment success (at least a two-grade reduction in the Evaluator’s Global Severity Score and clear/almost clear). Safety, adverse events (AEs), and cutaneous tolerability were evaluated. Results: At Week 12, mean percent reductions in inflammatory and noninflammatory lesion counts were 49.5% and 44.0% in preadolescents and 50.5% and 41.2% in adolescents, compared to 31.4%, 18.8%, 35.9%, and 23.8% for the vehicle, respectively (all p ≤0.001). Treatment success was achieved by 23.7% (preadolescent) and 17.5% (adolescent) of subjects by Week 12, compared to 7.2% ( p =0.009) and 8.8% ( P =0.004) with the vehicle. The majority of AEs were mild and transient; the most frequent occurrences were application site pain and dryness in 5.6% and 2.8% of preadolescents and 3.2% and 3.6% of adolescents. Local cutaneous safety and tolerability assessments were generally mild-to-moderate, with slight transient increases in mean scores at Week 4. Conclusions: Tretinoin 0.05% lotion was significantly more effective than the vehicle in achieving treatment success and reducing inflammatory and noninflammatory lesions in preadolescent and adolescent acne. It was well tolerated, and all treatment-related AEs were mild or moderate.