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Randomized, Triple-Blind, Placebo-Controlled Trial of Topical Dapsone Gel in Patients With Acne Vulgaris
Sponsor: Oya Helin Dundar
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
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.
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)