Novel Tretinoin Lotion Safe, Effective for Acne Treatment in Hispanic Patients

The following article is part of conference coverage from the 2018 Fall Clinical Dermatology Conference in Las Vegas, Nevada.Dermatology Advisor’s staff will be reporting breaking news associated with research conducted by leading experts in dermatology. Check back for the latest news from Fall Clinical Derm 2018.

Tretinoin 0.05% lotion has demonstrated efficacy, safety, and tolerability in treating moderate to severe acne vulgaris in Hispanic individuals. This research was presented at the 2018 Fall Clinical Dermatology Conference, held October 18-21, 2018, in Las Vegas, Nevada.

This post hoc analysis included 766 Hispanic participants randomly assigned 1:1 to either tretinoin 0.05% lotion or vehicle, which were applied daily for a 12-week period. The studies included in this post hoc analysis were double-blind, vehicle-controlled, multicenter Phase 3 studies whose participants were between 11 and 50 years old. Primary efficacy assessments evaluated the change in lesions from baseline and success of treatment, defined as clear/almost clear and a reduction of at least 2 grades in Evaluator’s Global Severity Score. There were frequent evaluations of safety, cutaneous tolerability, and adverse events.

At the 12-week mark, inflammatory lesion reductions were 60.1% in the tretinoin group vs 51.1% in the vehicle groups, while non-inflammatory lesion reductions were 53.0% vs 38.7% (P ≤.001 for all).

At week 12, 19.6% of the tretinoin group and 12.7% of the vehicle group (P =.015) had achieved treatment success. Each group experienced 2 serious adverse events, while most adverse events associated with tretinoin 0.05% lotion were mild and included pain at application site (2.0%), dryness (1.4%), and erythema (1.2%). These events were largely transient. Assessments of local cutaneous safety and tolerability ranged from mild to moderate, and showed improved by the 12-week mark. Mean scores increased mildly from weeks 0 to 4, but were likely transient.

The study researchers conclude that “[tretinoin] 0.05% lotion was significantly more effective than its vehicle in achieving treatment success and reducing inflammatory and noninflammatory acne lesions in a Hispanic population. The new lotion formulation was well tolerated, and all treatment-related AEs were both mild and transient in nature.”

Disclosures: E. Guenin is an employee of Ortho Dermatologics; V Bhatt is an employee of Dow Pharmaceutical Sciences Inc. The study was supported by Ortho Dermatologics.

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Reference

Cook-Bolden FE, Weinkle SH, Guenin E, Bhatt V. Novel tretinoin 0.05% lotion for the once-daily treatment of moderate-to-severe acne vulgaris in a hispanic population. Presented at: Fall Clinical Dermatology Conference. October 18-21, 2018; Las Vegas, NV.