Clinical Trial

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

Completed Phase 4
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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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-11-21; most recent amendment 2026-05-19.
Status change: Enrolling by Invitation → Completed 2026-05-05
Trial Details
NCT Number NCT07244887
Lead Sponsor Oya Helin Dundar
Collaborators: Istanbul Training and Research Hospital
Conditions Acne Vulgaris
Enrollment 100 participants
Start Date 2025-06-17
Primary Completion 2026-02-01 (estimated)
Study Completion 2026-03-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-22