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
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
- 否
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
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