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Acne vulgaris (AV) is a communal skin condition in children and adolescents. Effectiveness of tretinoin is well documented in studies that included pediatric patients – 12-18 years of age. Lotion formulations are commonly used across dermatology and are well liked by patients.
The purpose of a recent study published in Pediatric Dermatology was to evaluate the safety and efficacy of a novel once-daily tretinoin 0.05% lotion in preadolescent subjects, ≤ 13 years, with moderate-to-severe acne.
The present study entailed a post hoc analysis of two multicenter, randomized, double-blinded, vehicle-controlled phase-3 studies in moderate-to-severe acne. Overall, 154 preadolescent subjects were randomized (1:1) to receive tretinoin0.05% lotion or vehicle—once daily for 12 weeks. Efficacy assessments were carried out–including changes in baseline inflammatory/noninflammatory lesions and treatment success—determined by at least 2-grade reduction in Evaluators Global Severity Score [EGSS] and clear/almost clear skin. Safety, adverse events (AEs) and cutaneous tolerability were evaluated at regular intervals.
It was noted that at week-12, the mean percent reduction in inflammatory and noninflammatory lesion counts were 49.5% and 44.0%, compared to 31.4% and 18.8%with vehicle. Treatment success was achieved by 23.7% of subjects by week-12,compared to 7.2%. The majority of AEs were mild and transient and most frequently, were application site pain (5.6%) and application site dryness(2.8%). Moreover, local cutaneous safety and tolerability assessments were generally mild-to-moderate and improved by week-12.
Hence, it was inferred that tretinoin 0.05% lotion is significantly more effective than vehicle in achieving treatment success and reducing inflammatory and noninflammatory lesions in preadolescent acne. It is well tolerated, and all treatment-related AEs are deemed mild or moderate.
Source: Pediatric Dermatology. 2019 Mar;36(2):193-199. doi: 10.1111/pde.13744.