Randomized, Triple-Blind, Vehicle-Controlled Trial Evaluating Clinical Efficacy, Sebum, Erythema, Melanin and Quality-of-Life Outcomes of Topical Dapsone Gel 7.5% in Patients With Acne Vulgaris
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in Inflammatory Lesion Count (Papules/Pustules)
研究概览
简要总结
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.
详细描述
This is a prospective, randomized, triple-blind, vehicle-controlled clinical trial designed to evaluate the clinical efficacy of topical 7.5% dapsone gel in adults with mild-to-moderate acne vulgaris. The study also investigates the effects of topical dapsone on skin biophysical parameters using standardized instruments: erythema and melanin indices measured with a Mexameter, and sebum index measured with a Sebumeter.
Two parallel arms were included: one group applied topical 7.5% dapsone gel once daily, and the other applied a matched vehicle gel identical in base, tube, and packaging but without the active ingredient. Randomization was performed using a pre-generated computer-based randomization sequence. Participants, dispensing investigators, outcome assessors, and data analysts were blinded to treatment allocation.
Participants attended clinic visits at baseline, week 4, week 8, and week 12. Treatment was applied for 8 weeks, followed by a 4-week treatment-free follow-up period through week 12. At each visit, standardized digital photographs were taken, and acne severity was assessed using the Global Acne Grading System (GAGS), lesion counts used to assign Plewig and Kligman comedonal and papulopustular stages, and standardized clinical evaluation. At each visit, Mexameter readings for erythema and melanin and Sebumeter readings for sebum were obtained at three predefined facial sites: right cheek, left cheek, and forehead. Triplicate measurements were obtained at each site after a standardized acclimatization period. The Turkish-validated Gupta Acne Quality of Life Scale was administered at baseline and week 8.
The primary objective was to determine whether topical 7.5% dapsone gel reduces inflammatory lesion burden compared with matched vehicle at week 8. Secondary evaluations included changes in Global Acne Grading System (GAGS) total score, comedonal acne stage, sebum index, erythema index, melanin index, acne-related quality of life, and local cutaneous adverse events. By combining standardized clinical assessments, patient-reported outcomes, and objective biophysical measurements, this trial aimed to evaluate the clinical and biophysical effects of topical 7.5% dapsone gel in acne vulgaris.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants, dispensing investigators, clinical outcome assessors, photographic evaluators, and data analysts were blinded to treatment allocation. Study products were identical in appearance, base, tube, and packaging and were labeled with coded allocation identifiers.
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 50 years with a clinical diagnosis of mild-to-moderate acne vulgaris.
- •No systemic or topical acne treatment within the past 1 month (30 days).
- •Able and willing to provide written informed consent.
排除标准
- •Pregnancy 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 outcome assessments.
- •Known hypersensitivity to dapsone or any component of the study product.
结局指标
主要结局
Change in Inflammatory Lesion Count (Papules/Pustules)
时间窗: Baseline to Week 8 (with interim assessment at Week 4)
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.
次要结局
- Change in Melanin Index (Mexameter)(Baseline to Week 8 (interim at Week 4))
- 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 Sebum Level (Sebumeter)(Baseline to Week 8 (interim at Week 4))
- Change in Acne-Specific Quality of Life (Acne-QoL) Total Score(Baseline to Week 8)
- Incidence of Local Cutaneous Adverse Events(Baseline to Week 8 (interim at Week 4))
研究者
Oya Helin Dundar
Dermatology Resident Physician
Istanbul Training and Research Hospital