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

NCT ID: NCT07244887

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-17
• Study Completion Date: 2026-08-31

Brief 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

Detailed Description

This is a prospective, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the clinical efficacy of topical 7.5% dapsone gel in the treatment of acne vulgaris. The study will also investigate effects on skin biophysical parameters using standardized instruments: erythema and melanin with a Mexameter, and sebum production with a Sebumeter.

Two parallel arms will be included: one group will apply 7.5% dapsone gel once daily, and the other will apply a vehicle (placebo) gel identical in appearance and packaging but without the active ingredient. Randomization will be computer-generated, and both investigators and participants will remain blinded to treatment allocation.

Participants will attend clinic visits at baseline (Day 0), Week 4, and Week 8. At each visit, standardized digital photographs will be taken, and lesion counts will be performed. Lesion assessments will include comedonal and papulopustular counts according to Plewig & Kligman, the Global Acne Grading System (GAGS), and the Investigator's Global Assessment (IGA). At each visit, Mexameter readings (erythema and melanin) and Sebumeter readings (sebum) will be obtained at three predefined facial sites (right cheek, left cheek, glabella/forehead) using triplicate measurements after a standardized acclimatization period. The Acne Quality of Life Index will be administered at baseline and Week 8.

Treatment with dapsone or placebo will continue for 8 weeks, after which the study ends for both arms. Following completion at Week 8, participants may initiate standard acne therapies as clinically indicated outside the study.

The primary focus is to determine whether dapsone gel significantly reduces inflammatory lesion counts compared with placebo at Week 8. Secondary evaluations include changes in comedonal lesion counts, acne severity scores (GAGS and IGA), erythema and melanin indices (Mexameter), sebum levels (Sebumeter), and patient-reported quality of life (Acne-QoL). By combining standardized clinical assessments, validated scoring systems, patient-reported outcomes, and objective biophysical measurements, this trial aims to generate robust evidence regarding the effectiveness of topical 7.5% dapsone in acne management.

Conditions

Acne Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Dapsone 7.5% Gel

Dapsone 7.5% topical gel applied once daily to the entire face for 8 weeks.

Group Type: EXPERIMENTAL

Dapsone 7.5 % gel

Intervention Type: DRUG

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.

Vehicle Gel

Vehicle (placebo) topical gel without dapsone, identical in base and packaging to the active product; applied once daily to the entire face for 8 weeks.

Group Type: PLACEBO_COMPARATOR

placebo vehicle gel

Intervention Type: DRUG

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.

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

topical dapsone 7.5% gel; Vulgarex (country-specific brand); placebo gel; vehicle gel

Eligibility Criteria

Inclusion Criteria

• Adults aged 18 to 50 years with a clinical diagnosis of acne vulgaris.
• No systemic or topical acne treatment within the past 1 month (30 days).
• Able and willing to provide written informed consent.

Exclusion Criteria

• Pregnant or breastfeeding.
• Systemic retinoid or systemic antibiotic use within the past 6 months.
• Active dermatologic or systemic disease that could interfere with study participation or assessments.
• Known hypersensitivity to dapsone or any component of the study product.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul Training and Research Hospital

OTHER_GOV

Sponsor Role: collaborator

FARMATEK TARIM SANAYİ MÜMESSİLLİK VE TİCARET ANONİM ŞİRKETİ

UNKNOWN

Sponsor Role: collaborator

Oya Helin Dundar

OTHER_GOV

Sponsor Role: lead

Responsible Party

Oya Helin Dundar

Dermatology Resident Physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Oya Helin Dundar, MD

Role: PRINCIPAL_INVESTIGATOR

Istanbul Training and Research Hospital, Dept. of Dermatology

Vildan Manav, MD, Assoc. Prof.

Role: STUDY_DIRECTOR

Istanbul Training and Research Hospital, Dept. of Dermatology

Ayse Esra Koku Aksu, MD, Prof.

Role: STUDY_CHAIR

Istanbul Training and Research Hospital, Dept. of Dermatology

Locations

Istanbul Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

Medipol-EC-210

Identifier Type: OTHER

Identifier Source: secondary_id

SBU-IEAH-AV-DAP7P5-RCT-EC210

Identifier Type: -

Identifier Source: org_study_id