Tretinoin Lotion Demonstrates Safety, Efficacy in Treating Preadolescent Acne

Scaling, stinging, and burning increased slightly during weeks 0 to 4 but were transient.

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 safety, tolerability, and efficacy in treating preadolescent acne, with no serious adverse events. This research was presented at the Fall Clinical Dermatology Conference, held October 18-21, 2018, in Las Vegas, Nevada.

The study was a post-hoc analysis of 2 phase 3, randomized, double-blind studies of moderate to acute acne. The studies included 154 children between the ages of 9 and 13 years who were randomly assigned to either tretinoin 0.05% or vehicle. Each was administered treatment daily for a 12-week period.

Changes in both inflammatory and noninflammatory lesions from baseline were assessed as part of efficacy, as was treatment success, defined as a ≥2-grade decrease in Evaluator’s Global Severity Score to clear or almost clear. The study researchers performed regular assessments for adverse events, safety, and cutaneous tolerability.

At the end of this period, inflammatory lesions had decreased by 49.5% in the tretinoin group and 31.4% in the vehicle group, and noninflammatory lesions had decreased by 44.0% and 18.8%, respectively (P =.001 for all). Overall, tretinoin resulted in 23.7% success at week 12, while vehicle resulted in 7.2% success (P =.009). Adverse events included pain (5.6%) and dryness (2.8%) at the application site, and most were transient. By week 12, local evaluations of cutaneous tolerability and safety (mostly mild to moderate) had improved. Scaling, stinging, and burning increased slightly during weeks 0 to 4 but were transient.

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

Disclosures: V Bhatt reports an association with Dow Pharmaceutical Sciences Inc. The study was supported by Ortho Dermatologics.

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Eichenfield LF, Bhatia N, Guenin E, Bhatt V. Safety and efficacy of a novel tretinoin 0.05% lotion in the treatment of moderate-to-severe acne vulgaris: post hoc analysis of 2 phase III randomized controlled trials in pediatric patients. Presented at: 2018 Fall Clinical Dermatology Conference. October 18-21, 2018; Las Vegas, NV.