NCT00927771Unknown4 期
Efficacy & Safety of Azelaic Acid 15% Gel vs. Hydroquinone 4% Cream in the Treatment of Melasma
Callender Center for Clinical Research1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2009年6月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Improvement of melasma
研究概览
简要总结
The purpose of this study is to compare the safety and effectiveness of Azelaic Acid Gel to Hydroquinone Cream in the treatment of melasma.
详细描述
Melasma is a chronic condition in which dark areas appear on the forehead, cheeks, and upper lips. Hydroquinone is a skin lightener (or fade cream) and is one of the most commonly used medications for the treatment of melasma. Azelaic acid gel is currently used to treat acne and rosacea.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •must have stable moderate-severe epidermal or mixed melasma involving the face
- •all races
- •males and females
- •persons taking birth control medication, hormone replacement therapy or any other hormone altering medication may participate only if they have not started or stopped the medication within the last 3 months
排除标准
- •if the person has only dermal melasma
- •pregnancy, breastfeeding, a positive pregnancy test in the office or plans to become pregnant
- •a known allergy or sensitivity ot azelaic acid or hydroquinone
- •the use of photosensitizing medications (ex. tetracycline) within 3 months of the study.
- •starting or stopping hormonal medication within 3 months
- •chemical peels, microdermabrasion, or laser treatment within 6 months
- •worsening or improving melasma
研究组 & 干预措施
Azelaic Acid
Experimental
干预措施: azelaic acid gel (Drug)
Hydroquinone
Active Comparator
干预措施: hydroquinone cream (Drug)
结局指标
主要结局
Improvement of melasma
时间窗: 6 months
次要结局
未报告次要终点
研究者
研究点 (1)
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