EUCTR2010-019994-13-FR进行中(未招募)1 期
EXPLORATORY STUDY TO EVALUATE THE SAFETY AND EFFICACY OF CD07387 SOLUTION IN PATIENTS WITH VITILIGO
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- GALDERMA R&D
- 入组人数
- 36
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
- •Subjects who meet the following key inclusion criteria may be eligible for the study:
- •The subject is a male or a female, aged 18 to 65 years old inclusive.
- •The female subject should be of non childbearing potential, i.e. female presenting with hysterectomy or bilateral ovariectomy, or having a bilateral tubal ligation, or postmenopausal female (absence of menses for at least 1 year without an alternative medical cause).
- •The subject has a clinical diagnosis of non-segmental (generalized) symmetrical vitiligo, with stable plaques on the trunk for more than 3 months (no change in pigmentation or size over the last 3 months for the plaque(s) to be treated).
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Any subject who meets one or more of the following key exclusion criteria will not be included in the study:
- •The subject has an underlying known disease, a surgical or medical condition (i.e. cardiovascular, endocrinological, psychatric, neurological,...) that, in the opinion of the investigator might put the subject at risk.
- •The subject has an underlying dermatological disease (i.e.: history of atopic dermatitis, eczema, psoriasis), which, in the judgment of the investigator, could interfere with the study assessments.
研究者
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