Clinical Research Directory

Randomized, Triple-Blind, Vehicle-Controlled Trial of Topical Dapsone Gel 7.5% in Patients With Acne Vulgaris

Sponsor: Oya Helin Dundar

Summary

The goal of this randomized, triple-blind, vehicle-controlled clinical trial is to evaluate whether topical 7.5% dapsone gel is effective for treating mild-to-moderate acne vulgaris in adults. The main questions are: * Does dapsone gel improve global acne severity compared with a matched vehicle gel? * Does dapsone gel improve comedonal and papulopustular acne severity? * Does dapsone gel reduce erythema and melanin indices measured with a Mexameter, and sebum index measured with a Sebumeter? * Does treatment with dapsone gel improve patients' acne-related quality of life? Researchers compared once-daily dapsone gel with a matched vehicle gel without the active ingredient. Participants: * Applied either dapsone gel or vehicle gel once daily for 8 weeks * Attended clinic visits at baseline, week 4, week 8, and week 12 * Had acne severity assessed using the Global Acne Grading System and Plewig and Kligman comedonal and papulopustular stages * Had erythema and melanin measured with a Mexameter, and sebum measured with a Sebumeter at predefined facial sites * Completed an acne quality-of-life questionnaire at baseline and week 8 * Had standardized photographs taken at each visit Treatment was continued for 8 weeks, followed by a 4-week treatment-free follow-up through week 12.

Official title: Randomized, Triple-Blind, Vehicle-Controlled Trial Evaluating Clinical Efficacy, Sebum, Erythema, Melanin and Quality-of-Life Outcomes of Topical Dapsone Gel 7.5% in Patients With Acne Vulgaris

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