Topical 20% Azelaic Acid Versus 4% Hydroquinone in Epidermal Melasma: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 146
- 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
Melasma is a common skin condition that causes dark patches on the face and can significantly affect quality of life. This study compared two commonly used topical treatments, 20% azelaic acid and 4% hydroquinone, in adults with epidermal melasma.
Participants with epidermal melasma were randomly assigned to receive either azelaic acid 20% or hydroquinone 4% for a period of 12 weeks. The severity of melasma was assessed at baseline and monthly using the Melasma Area and Severity Index (MASI) score. Side effects such as irritation, redness, burning, itching, and dryness were also monitored throughout the study.
The purpose of this study was to compare the effectiveness and safety of azelaic acid and hydroquinone in reducing melasma severity and to determine whether azelaic acid can be used as a safe alternative to hydroquinone.
详细描述
This randomized controlled trial was conducted in the Dermatology Department of Gujranwala Medical College Hospital, Gujranwala, from 4 May 2025 to 3 August 2025. The study was designed to compare the efficacy and safety of topical 20% azelaic acid and 4% hydroquinone in the treatment of epidermal melasma.
A total of 146 patients with clinically diagnosed epidermal melasma confirmed by Wood's lamp examination were enrolled. Patients of any age and gender were eligible. Exclusion criteria included dermal or mixed-type melasma, active skin infections, history of keloid formation, recent use of other depigmenting agents, photosensitive disorders, pregnancy or lactation, and refusal to provide written informed consent.
After obtaining informed consent, participants were randomly assigned to one of two treatment groups in a parallel design. Group A received topical azelaic acid 20%, and Group B received topical hydroquinone 4%. Participants were blinded to their treatment allocation, while treating clinicians and research staff were aware of the assigned treatment. The statistician analyzing the data was blinded to group allocation.
Both treatments were administered for a duration of 12 weeks. Participants were evaluated at baseline and then monthly. All participants were advised to use broad-spectrum sunscreen throughout the study period. Treatment compliance and adverse effects were assessed at each follow-up visit. Any adverse effects such as erythema, burning, itching, or dryness were managed with supportive care, including emollients or antihistamines if required.
The primary outcome measure was treatment efficacy, assessed by the change in Melasma Area and Severity Index (MASI) score from baseline to the end of the 12-week treatment period. Secondary outcomes included the rate of improvement over time and the safety and tolerability of both treatments.
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
- Single (Participant)
盲法说明
Participants were blinded to treatment allocation. Treating clinicians and study staff were aware of group assignments. The statistician analyzing the data received coded datasets and was blinded to treatment allocation.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with clinically diagnosed epidermal melasma confirmed by Wood's lamp examination
- •Male or female participants of any age
- •Willingness to provide written informed consent
- •Ability to comply with study procedures and follow-up visits
排除标准
- •Dermal or mixed-type melasma
- •Active cutaneous or facial skin infection
- •History of keloid formation
- •Recent use of other topical or systemic depigmenting agents
- •Presence of photosensitive disorders
- •Pregnancy or lactation
- •Refusal or inability to provide written informed consent
研究组 & 干预措施
GroupA
Subjects were randomised into two intervention groups of 73 each by paralel assignment .
Group A (Azelaic Acid 20%) Description Group A Participants were assigned to 20%Azalic acid daily application for 12weeks as intervention for treatment of Melasma.
干预措施: Topical Azelaic Acid 20% Cream (Drug)
GroupB
Group B (Hydroquinone 4%) Description the other grouphad also 73 participants.They were assigned to 4%Hydroquinone daily application for 12 as intervention for treatment of Melasma.
干预措施: Topical 4% hydroquinone cream (Drug)
结局指标
主要结局
Change in Melasma Area and Severity Index (MASI) Score
时间窗: Baseline to 12 weeks
The primary outcome was treatment efficacy, assessed by the change in the Melasma Area and Severity Index (MASI) score from baseline to the end of the 12-week treatment period. MASI evaluates the severity of melasma based on area of involvement, darkness, and homogeneity across four facial regions.
次要结局
未报告次要终点
研究者
Yasan Saaqib
5th year resident
Gujranwala medical college District Headquarters Hospital, Gujranwala