EUCTR2013-003501-25-ES进行中(未招募)不适用
Efficacy and safety of a 4% hydroquinone cream (Melanoderm 4%) for the treatment of melasma: a randomized controlled split-face study.
Mesoestetic Pharma group S.L.0 个研究点开始时间: 2013年11月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Adult women aged between 18-75 years old.
- •Fitzpatrick phototypes I to IV.
- •Presenting noderate to severe facial melasma facial, with a basal MASI Index between 10 and 20.
- •Women of childbearing potential must use an adecuate contraceptive method to avoid pregnancy and must have a negative pregnancy test in a maximum of 72 hours before receiving the trial treatment.
- •Breastfeeding women will not be included in the study.
- •Having given freely and expressly her informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Those with any history of allergy or hypersensitivity to a cosmetic product, hydroquinone, or one of the ingredients of the investigational products.
- •Fitzpatrick phototype V.
- •Skin pigmentation diseases different to melasma.
- •Evidence of active cancer disease or diagnosis of cancer in the last year.
- •Those receiving any topical or oral treatment that could interfere with melasma.
- •Pregnant or breastfeeding women, or those expecting to get pregnant during the study.
- •Evidence or suspicion of low compliance with the study visits and proecedures.
- •Participation in other clinical trial simultaneously or in the previous 3 months.
研究者
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