Efficacy and Safety of a Combined Topical Formula (Azelaic Acid and Tranexamic Acid) Versus Placebo in Patients With Melasma: Randomized, Double-blind, Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Melasma Area and Severity Index (MASI) score
研究概览
简要总结
The goal of this clinical trial is to learn whether a topical formulation containing 12% azelaic acid and 5% tranexamic acid is effective and safe for treating melasma in adults. The main questions it aims to answer are:
Does the topical formulation reduce melasma severity compared with placebo after 4 weeks of treatment? Is the topical formulation safe and well tolerated?
Researchers will compare the active topical formulation with a placebo cream to determine whether the active treatment provides greater improvement in melasma severity and quality of life.
Participants will:
Be randomly assigned to receive either the active topical formulation or a placebo cream.
Apply the assigned treatment daily for 4 weeks. Attend scheduled clinical visits for assessment of melasma severity using the Melasma Area and Severity Index (MASI), quality of life using the Melasma Quality of Life Scale (MelasQoL), and standardized facial imaging with the VISIA® skin analysis system.
Be monitored for local adverse events throughout the study.
详细描述
Melasma is a chronic acquired pigmentary disorder characterized by symmetrical facial hyperpigmentation that significantly affects patients' quality of life. Although several topical therapies are available, treatment responses are often variable and recurrence is common. Azelaic acid inhibits melanogenesis through tyrosinase inhibition, whereas tranexamic acid modulates inflammatory and vascular pathways involved in melasma pathogenesis. Their complementary mechanisms suggest that combined topical administration may provide greater therapeutic benefit than either approach alone.
This is a randomized, double-blind, placebo-controlled, parallel-group clinical trial designed to evaluate the efficacy and safety of a topical formulation containing 12% azelaic acid and 5% tranexamic acid compared with placebo in adults with melasma. Participants are randomly assigned to receive either the active formulation or placebo and are followed for four weeks. Clinical efficacy is assessed using the Melasma Area and Severity Index (MASI), patient-reported quality of life using the Melasma Quality of Life Scale (MelasQoL), and standardized facial imaging with the VISIA® skin analysis system. Safety is evaluated through the monitoring and documentation of local adverse events throughout the study.
The findings of this study are expected to provide evidence regarding the clinical efficacy, safety, and tolerability of this combined topical formulation as a potential therapeutic option for the treatment of melasma.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The investigational product and placebo were prepared, coded, and labeled by personnel independent of the clinical investigators. Participants, investigators, and outcome assessors remained blinded to treatment allocation throughout the study. The treatment code was maintained separately and was not disclosed until completion of the study.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 60 years.
- •Clinical diagnosis of facial melasma.
- •Fitzpatrick skin phototypes II to V.
- •Willing and able to comply with all study procedures and scheduled visits.
- •Willing to use sunscreen throughout the study.
- •Provided written informed consent.
排除标准
- •Pregnancy or breastfeeding.
- •Known hypersensitivity to azelaic acid, tranexamic acid, or any component of the study formulation.
- •Use of topical or systemic treatment for melasma within the previous 3 months.
- •Presence of facial skin diseases or active skin infections that could interfere with study assessments.
- •Participation in another clinical trial during the study period.
- •Any medical condition that, in the investigator's judgment, could interfere with study participation or evaluation of the outcomes.
结局指标
主要结局
Change in Melasma Area and Severity Index (MASI) score
时间窗: Baseline and Week 4
Change in the Melasma Area and Severity Index (MASI) from baseline to Week 4. MASI was assessed by the investigator to evaluate clinical severity of melasma.
次要结局
- Change in Melasma Quality of Life Scale (MELASQoL) score(Baseline and Week 4)
- Change in facial pigmentation assessed by VISIA®(Baseline and Week 4)
- Incidence of treatment-related adverse events(Throughout the 4-week treatment period)
研究者
Emmanuel Valdes Alvarado
Researcher Proffesor
University of Guadalajara