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

NCT07244887 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-05-22

No results posted yet for this study

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.

Conditions

  • Acne Vulgaris

Interventions

DRUG

Dapsone 7.5% gel

Topical dapsone 7.5% gel applied once daily to the entire face for 8 weeks; route: topical. The study product was supplied in an identical-appearing tube to maintain masking. Participants were followed for 4 weeks after treatment discontinuation.

DRUG

Vehicle gel

Vehicle gel without dapsone, identical in base, tube, and packaging to the active product; applied once daily to the entire face for 8 weeks; route: topical. Participants were followed for 4 weeks after treatment discontinuation.

Sponsors & Collaborators

  • Istanbul Training and Research Hospital

    collaborator OTHER_GOV

  • Oya Helin Dundar

    lead OTHER_GOV

Principal Investigators

  • Oya Helin Dundar, MD · Istanbul Training and Research Hospital, Dept. of Dermatology

  • Vildan Manav, MD, Assoc. Prof. · Istanbul Training and Research Hospital, Dept. of Dermatology

  • Ayse Esra Koku Aksu, MD, Prof. · Istanbul Training and Research Hospital, Dept. of Dermatology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-17
Primary Completion
2026-02-01
Completion
2026-03-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07244887 on ClinicalTrials.gov