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临床试验/NCT01082393
NCT01082393已完成4 期

Vitiligo and the Koebner Phenomenon (Model of Vitiligo Induction and Therapy: a Clinical and Immunological Analysis)

University Hospital, Ghent1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2010年2月16日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
14
试验地点
1
主要终点
percentage of skin pigmentation in the treated area

研究概览

简要总结

We will investigate the process of vitiligo induction and the influence of different commonly used cream treatments on this process. Studies comparing different treatments for vitiligo in the induction stage of the disease are still missing. The study hypothesis = cream treatment can stop actively spreading vitiligo lesions during the early induction stage of the disease.

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, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female,
  • Age 18-70 years,
  • Extensive vitiligo (> 50% body surface area),
  • Patients asking for depigmenting therapy,
  • Not pregnant.

排除标准

  • Children,
  • Non extensive vitiligo (< 50% boy surface area),
  • Patients not asking for depigmenting therapies,
  • Pregnant.

研究组 & 干预措施

topical tacrolimus

Active Comparator

干预措施: topical tacrolimus treatment (Drug)

topical pimecrolimus

Active Comparator

干预措施: topical pimecrolimus treatment (Drug)

local steroids

Active Comparator

干预措施: local mometasone furoate treatment (Drug)

cold cream

Placebo Comparator

干预措施: cold cream (Drug)

结局指标

主要结局

percentage of skin pigmentation in the treated area

时间窗: after 1 day, 10 days, 30 days and 60 days

digital image analysis system for surface measurement

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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