EUCTR2005-002820-32-DE进行中（未招募）1 期
A Multi-Center, Double-Blind, Randomized, Dose-Ranging Study of the Safety and Efficacy of IDP-102 Gel 5 %, and 15 % Compared with Vehicle in the Treatment of Common Warts.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 107
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Males or females, 18 to 75 years of age.
- •Clinical diagnosis of common warts (non plantar and non-subungual).
- •At least 2 but not more than 15 common warts (minimum total wart area of 16 mm2).
- •Willing and able to provide verbal and written informed consent.
- •Women of childbearing age must have a negative pregnancy test and must be using a highly effective method of birth control (failure rate < 1 %).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects must not be pregnant or lactating.
- •Dermatosis in the vicinity of the warts that could interfere with clinical evaluations.
- •Current immunosuppressive diseases or medication.
- •History of a hypersensitivity to any ingredients in IDP-102 Gel listed in appendix A of the protocol.
- •Subjects using a medication whose mechanism of action involves ganglionic blocking agents should be excluded.
- •Any wart treatment or treatment with any investigational drugs within 30 days of the day 1 Visit.
研究者
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