Vitiligo
Conditions
Keywords
Vitiligo, Tacrolimus, Face
Brief summary
Multicentric French parallel double-blind randomized versus placebo study
Detailed description
Multicentric French parallel double-blind randomized versus placebo study, with duration of treatment of 6 months, and a post-treatment follow-up period of 6 months
Interventions
DRUGtacrolimus
tacrolimus 0.1% ointment applied twice a day for the experimental group during 24 weeks placebo ointment applied twice a day for the control group during 24 weeks
DRUGPlacebo
Sponsors
University Hospital, Bordeaux
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject male or female with age over 18 years old 2. Diagnosis of non-segmental (symmetrical) vitiligo 3. Presence of at least one vitiligo target-plaque on the face, with: Area greater than 3cm² Local Vitiligo Area Severity Index (VASI) score ≥ 50% Stable (no change in pigmentation or size over the last 3 months) Recent onset (less than 2 years duration) 4. Subject affiliated to the French social security system
Exclusion criteria
1. Progressive vitiligo over the last 3 months 2. Spontaneous ongoing repigmentation (documented in the last 3 months) 3. Previous topical Tacrolimus treatment in the last 3 months 4. Previous topical or systemic treatment in the last month: Topical or oral corticosteroid Topical vitamin D Phototherapy or laser Other topical treatment specific to vitiligo Other immunosuppressant or immunomodulator 5. Underlying dermatological disease (i.e.: history of atopic dermatitis, eczema, psoriasis), which, according to the investigator, could interfere with the study assessments 6. Known sensitivity to study drug or macrolides 7. Past history of skin cancer or lymphoma 8. Congenital or acquired immunodeficiency 9. Pregnant or breastfeeding women 10. Women without contraception 11. Absence of signed informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of repigmented surface area of the target lesion ≥75% | One year | To test the efficacy of a 24 weeks months Tacrolimus 0.1% ointment treatment vs placebo in an adult population with stable non-segmental vitiligo of the face. Therapeutic success is defined as the variation in percentage of repigmented surface area of the target lesion ≥75% at 24 weeks months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Variation of the Dermatology Life Quality Index | 24 weeks | Variation of the Dermatology Life Quality Index (DLQI) between inclusion and after 24 weeks of treatment between the 2 groups |
| Number of participants with Adverse events | 24 weeks | — |
| Variation in percentage of repigmented surface area | 24 weeks | Variation in percentage of repigmented surface area of the target lesion between week 24 and week 48 (observation period) in patients who were successfully treated (observation period) |
| Variation of patient's global satisfaction using Likert score | 12 weeks | Variation of patient's global satisfaction using Likert score at each follow-up visit |
| Variation of the physician global evaluation of treatment efficacy | 12 weeks | Variation of the physician global evaluation of treatment efficacy on facial vitiligo using Likert score at each follow-up visit |
Countries
France
Outcome results
None listed