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临床试验/NCT00152048
NCT00152048已完成4 期

A 24 Week Randomised Double Blind Placebo Controlled Study to Evaluate the Atrophogenic Potential of Eflornithine in the Treatment of Women With Excessive Facial Hair

Allergan0 个研究点目标入组 78 人开始时间: 2004年11月30日最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
Allergan
入组人数
78
主要终点
Change in facial skin thickness measured by ultrasound at 24 weeks

研究概览

简要总结

The purpose of this study is to evaluate whether regular use of eflornithine 11.5% cream in treating women with facial hair will induce skin damage (atrophy) on the face and/or forearms

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

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female subjects with clinical diagnosis of facial hirsutism/excessive facial hair
  • Women of childbearing potential must agree to use an effective form of birth control for the duration of the study
  • Skin type I-IV
  • Customary frequency of removal of facial hair two or more times per week

排除标准

  • Pregnant or lactating women
  • Severe inflammatory acne or presence of significant scarring on the face
  • History of skin malignancy
  • Connective tissue disorders

结局指标

主要结局

Change in facial skin thickness measured by ultrasound at 24 weeks

次要结局

  • Skin biopsies
  • Histology and histochemistry in the dermis
  • Physician Global Assessment
  • Subject Self-Assessment Questionnaire

研究者

发起方
Allergan
申办方类型
Industry
责任方
Sponsor

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