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临床试验/NCT01092884
NCT01092884已完成不适用

Polypodium Leucotomos Extract as an Adjunct to Sunscreen for the Treatment of Melasma

University of Texas Southwestern Medical Center0 个研究点目标入组 40 人开始时间: 2010年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
主要终点
Mexameter score

研究概览

简要总结

We will assess whether oral supplementation with Polypodium leucotomos, a commercially marketed fern extract, improves facial melasma in Hispanic women with moderate to severe melasma. Subjects will be randomized to either Group 1, which will receive oral Polypodium leucotomos extract plus topical sunscreen, or Group 2, which will receive oral placebo plus topical sunscreen. The study will last 12 weeks, and we hypothesize that the Polypodium leucotomos group will have more improvement in their melasma compared to the placebo group.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Hispanic female with moderate to severe facial melasma

排除标准

  • Currently pregnant or breastfeeding
  • Recent use of hydroquinone, topical retinoids, topical steroids, or mechanically abrading procedures (such as laser therapy or dermabrasion) to the face
  • Frequent use of tanning parlors

结局指标

主要结局

Mexameter score

时间窗: 12 weeks

Using rapid, non-invasive, narrow-band reflectance spectrophotometry (Mexameter), we will assess change in intensity of pigment in affected skin versus unaffected skin at 12 weeks

次要结局

  • Melasma-Related Quality of Life(12 weeks)
  • MASI Score(12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

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