Vitiligo MedDRA version: 12.1 Level: LLT Classification code 10047642 Term: Vitiligo
Conditions
Interventions
Product Code: CD07387
Pharmaceutical Form: Cutaneous solution
Current Sponsor code: CD07387
Concentration unit: % percent
Concentration type: equal
Concentration number: 2-
Pharmaceutical form of the
Sponsors
GALDERMA R&D
Eligibility
Sex/Gender
All
Inclusion 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Safety objectives: - Evaluation of the local tolerance of CD07387 solution on Vitiligo skin - Evaluation of the systemic safety by adverse events recording, physical examination (including body weight), vital signs, ECG and laboratory safety tests Efficacy objectives: - Assessment of a potential effect on pigmentation of CD07387 solution versus vehicle on Vitiligo skin;Secondary Objective: - Pharmacodynamic assessments: quantification of melanin and determination of the presence of epidermal melanocytes on zones treated by CD07387 solution vs vehicle (skin biopsies);Primary end point(s): • Local tolerability. | — |
Countries
France
Outcome results
None listed