Efficacy of Tacrolimus in Adults With Facial Non-segmental Vitiligo - VITAC

Efficacy of Tacrolimus Ointment 0.1% Versus Placebo in Adults With Facial Non-segmental Vitiligo: a Randomized Double-blind Controlled Study

Multicentric French parallel double-blind randomized versus placebo study

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

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