Novel Tretinoin 0.05% Lotion for the Once-Daily Treatment of Moderate-to-Severe Acne Vulgaris in an Asian Population

Abstract

BACKGROUND: Acne is a common problem among Asian adolescents and adults. Generally, Asian skin is more pigmented, with a higher risk of acne sequelae. Potential for skin irritation and dryness, as well as pigmentary changes are key concerns that can have significant impact on Quality of Life (QoL). The first lotion formulation of tretinoin was developed using novel polymeric emulsion technology to provide an important alternative option to treat acne patients who may be sensitive to the irritant effects of other tretinoin formulations. OBJECTIVE: To evaluate the efficacy, tolerability, and safety of tretinoin 0.05% lotion in treating moderate-to-severe acne in an Asian population. METHODS: Post hoc analysis of two multicenter, randomized, double-blind, vehicle-controlled phase 3 studies. Asian subjects (aged 12 to 48 years, N=69 with 61% female) were randomized (1:1) to receive tretinoin 0.05% lotion or vehicle, once-daily for 12 weeks. Efficacy assessments included changes in baseline inflammatory and noninflammatory lesions and treatment success (at least 2-grade reduction in Evaluator’s Global Severity Score [EGSS] and clear/almost clear). Quality of Life (QoL) was assessed using the validated Acne QoL scale. Safety, adverse events (AEs), cutaneous tolerability and hyper- or hypo-pigmentation (using 4-point scales where 0=none and 3=severe) were evaluated. RESULTS: At week 12, mean percent reduction in inflammatory and noninflammatory lesion counts were 58.6% and 51.4% respectively compared with 41.5% and 23.9% with vehicle (P=0.012 for noninflammatory lesions from week 8). Treatment success was achieved by 27.2% of subjects treated with tretinoin 0.05% lotion by week 12. For each Acne QoL domain, changes from baseline achieved with tretinoin 0.05% lotion were statistically significant compared to vehicle. Only five subjects reported any AE; all AEs were mild or moderate and transient. There were no serious AEs (SAEs). There were no treatment-related AEs with tretinoin 0.05% lotion. There were slight transient increases in scaling and burning over the first 4-8 weeks. Mild hyperpigmentation was reported at baseline (mean score, 0.8) and remained mild throughout the study. CONCLUSIONS: Post hoc analysis showed that tretinoin 0.05% lotion was significantly more effective than its vehicle in achieving reductions in noninflammatory acne lesions and improvements in QoL in an Asian population. The novel lotion formulation was well-tolerated, with no treatment-related AEs and no concerns with skin dryness, irritation, or hyperpigmentation. J Drugs Dermatol. 2019;18(9):910-916.