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

NCT07244887 | Enrolling By Invitation Phase 4

• 2 other identifiers: SBU-IEAH-AV-DAP7P5-RCT-EC210Medipol-EC-210
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Acne Vulgaris

Keywords

Dapsone gel; Topical dapsone 7.5%; Vehicle gel; Mexameter; Erythema; Sebum; Sebumeter; Melanin; Global Acne Grading System (GAGS); Acne Quality of Life Index (AQLI); Acne Lesion Count; Papulopustular acne; Comedonal acne

Outcome Measures

Primary Outcomes (1)

• Change in Inflammatory Lesion Count (Papules/Pustules)

  Mean change from baseline in the number of inflammatory facial acne lesions (papules and pustules) per Plewig \& Kligman. Blinded dermatologist, standardized facial mapping. Between-group comparison: topical 7.5% dapsone gel vs vehicle/placebo gel.

  Baseline to Week 8 (with interim assessment at Week 4)

Secondary Outcomes (7)

• Change in Comedonal Lesion Count

  Baseline to Week 8 (with interim assessment at Week 4)

• Change in Global Acne Grading System (GAGS) Total Score

  Baseline to Week 8 (interim at Week 4)

• Change in Erythema Index (Mexameter)

  Baseline to Week 8 (interim at Week 4)

• Change in Melanin Index (Mexameter)

  Baseline to Week 8 (interim at Week 4)

• Change in Sebum Level (Sebumeter)

  Baseline to Week 8 (interim at Week 4)

Study Arms (2)

Dapsone 7.5% Gel

EXPERIMENTAL

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

Drug: Dapsone 7.5 % gel

Vehicle Gel

PLACEBO COMPARATOR

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.

Drug: placebo vehicle gel

Interventions

Dapsone 7.5 % gel 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.

Also known as: topical dapsone 7.5% gel, Vulgarex (country-specific brand)

Dapsone 7.5% Gel

placebo vehicle gel 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.

Also known as: placebo gel, vehicle gel

Vehicle Gel

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oya Helin Dundar: lead
• FARMATEK TARIM SANAYİ MÜMESSİLLİK VE TİCARET ANONİM ŞİRKETİ: collaborator
• Istanbul Training and Research Hospital: collaborator

Study Sites (1)

Istanbul Training and Research Hospital

Istanbul, 34000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Acne Vulgaris; Erythema

Interventions

Dapsone; Gels

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfones; Sulfur Compounds; Organic Chemicals; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Oya Helin Dundar, MD

  Istanbul Training and Research Hospital, Dept. of Dermatology

  PRINCIPAL INVESTIGATOR

• Vildan Manav, MD, Assoc. Prof.

  Istanbul Training and Research Hospital, Dept. of Dermatology

  STUDY DIRECTOR

• Ayse Esra Koku Aksu, MD, Prof.

  Istanbul Training and Research Hospital, Dept. of Dermatology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dermatology Resident Physician

Study Record Dates

• First Submitted: September 10, 2025
• First Posted: November 24, 2025
• Study Start: June 17, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-11

Locations

TU (1)