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ENROLLING BY INVITATION
NCT07244887
PHASE4

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

Sponsor: Oya Helin Dundar

View on ClinicalTrials.gov

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

Official title: Randomized, Triple-Blind, Placebo-Controlled Evaluation of the Clinical Efficacy of Topical Dapsone Gel and Its Effects on Sebum, Erythema and Melanine in Patients With Acne Vulgaris

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2025-06-17

Completion Date

2026-08

Last Updated

2025-12-05

Healthy Volunteers

No

Conditions

Interventions

DRUG

Dapsone 7.5 % gel

Topical dapsone 7.5% gel applied once daily to the entire face for 8 weeks; route: topical; identical-appearing tube to placebo. Manufacturer: Farmatek A.Ş.

DRUG

placebo vehicle gel

Vehicle gel without dapsone; same base/excipients and packaging as the active product; applied once daily to the entire face for 8 weeks; route: topical. Manufacturer: Farmatek A.Ş.

Locations (1)

Istanbul Training and Research Hospital

Istanbul, Turkey (Türkiye)