跳至主要内容
临床试验/EUCTR2013-003501-25-ES
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

发起方
Mesoestetic Pharma group S.L.

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