A Pharmacovigilance Study of Topical Acne Monotherapy with 0.1% Adapalene, and A Molecular Analytical Review of Adapalene in Evidence-Based Dermatopharmacological Treatment

Abstract

Acne vulgaris causes cosmetic impairment. User-friendly anti-acne monotherapy with adapalene has activity against the acne pathophysiology, with very minimal adverse effects. Retinoids, like adapalene, are comedolytic and anti-inflammatory. This study was conducted as a pharmacovigilance study of topical acne monotherapy with 0.1% adapalene, and a molecular analytical review of adapalene in evidence-based dermatopharmacological treatment. A prospective, open- labelled study was done, on 75 patients, with mild to moderate acne. Patients applied 0.1% adapalene topical monotherapy, once daily in the evening, over affected areas on the face, and left overnight. Efficacy was measured by percentage reduction in non-inflammatory, inflammatory and total lesion counts on 0, 15, 30, 60 and 90 days; and severity of lesions was assessed by Investigator’s Global Evaluation Scale and the occurrence of adverse effects like erythyma, dryness, scaling, burning and pruritus, were assessed by the Local Irritation Scale, among the patients receiving the monotherapy. An analytical review of the molecular pharmacology of adapalene in evidence-based dermatopharmacological treatment was thoroughly performed. The patients showed highly significant reduction in total lesion counts from baseline. No serious adverse effects were observed; and the observations were statistically non-significant. The molecular analytical review described significantly effective evidence-based dermatopharmacological response mechanisms of adapalene therapeutics. Topical 0.1% adapalene monotherapy was effective and safe, with significant evidence-based molecular dermatopharmacological efficacy.