EXPLORATORY STUDY TO EVALUATE THE SAFETY AND EFFICACY OF CD07387 SOLUTION IN PATIENTS WITH VITILIGO

Phase 1

• Conditions: Vitiligo; MedDRA version: 12.1Level: LLTClassification code 10047642Term: Vitiligo

• Registration Number: EUCTR2010-019994-13-FR
• Lead Sponsor: GALDERMA R&D

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-09-27
• Study Completion: 2011-05-09
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified