跳至主要内容
临床试验/NCT05119413
NCT05119413已完成2 期

Comparison of a New Masterful Preparation to Kligman's Trio in the Treatment of Melasma: a Double Blind Prospective Randomzed Study

Centre Hospitalier Universitaire de Nice1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年11月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
40
试验地点
1
主要终点
The melasma's type

研究概览

简要总结

Kligman's trio remains the gold standard treatment for melasma. It contain hydroquinone which is an effective anti-melanogenic compound but that has poor tolerance and numerous side-effects. Thiamidol has been proven to be at least as effective as hydroquinone and has a very good safety profile. The objective of this study is to compare the Kligman's trio to the same preparation in which hydroquinone is replaced by thiamidol.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • SIGNED WRITTEN CONSENT 1) Melasma clinically diagnosed

排除标准

  • Pregnant woman
  • Other pigmentary disorder affecting the face
  • Use of systemic or topical steroids or retinoids, use of topical depigmenting agents or depigmenting procedure in the month before the inclusion

研究组 & 干预措施

New traitement

Experimental

Thiamidol, retinoid, topical steroid preparation

干预措施: New trio de Kligman (Drug)

Kligman's trio

Other

Application once a day for 12 weeks

干预措施: Trio Kligman (Drug)

结局指标

主要结局

The melasma's type

时间窗: at 12 weeks

Clinical score MASI

次要结局

  • the Quality of life of patient(at 12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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