EUCTR2010-019994-13-FR
Active, not recruiting
Phase 1
EXPLORATORY STUDY TO EVALUATE THE SAFETY AND EFFICACY OF CD07387 SOLUTION IN PATIENTS WITH VITILIGO
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- GALDERMA R&D
- Enrollment
- 36
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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