Overview

Randomized, Double-Blind, Placebo-Controlled Trial of Topical Dapsone Gel in Patients With Acne Vulgaris

Status:
ENROLLING_BY_INVITATION
Trial end date:
2026-08-01
Target enrollment:
Participant gender:
Summary
The goal of this randomized, double-blind, placebo-controlled clinical trial is to learn whether topical 7.5% dapsone gel is effective for treating acne vulgaris in adults. The main questions are: * Does dapsone gel reduce the number and severity of acne lesions compared with a placebo (vehicle) gel? * Does dapsone gel improve skin redness (erythema) and pigmentation (melanin) measured with a Mexameter, and reduce skin oiliness (sebum) measured with a Sebumeter? * Does treatment with dapsone gel improve patients' quality of life? Researchers will compare once-daily dapsone gel with a look-alike placebo gel (no active ingredient). What participants will do: * Apply either dapsone gel or placebo gel once daily for 8 weeks * Attend clinic visits at baseline (start), week 4, and week 8 * Have acne lesions counted and graded at each visit * Have erythema and melanin measured with a Mexameter, and sebum measured with a Sebumeter at predefined facial sites (both cheeks and the glabella) * Complete a quality-of-life questionnaire at baseline and week 8 * Have standardized photographs taken at each visit
Phase:
PHASE4
Details
Lead Sponsor:
Oya Helin Dundar
Collaborator:
Istanbul Training and Research Hospital
Treatments:
Dapsone
Gels