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

University Hospital of Bordeaux

Status and phase: Completed; Phase 3

Conditions: Vitiligo

Treatments: Drug: tacrolimus; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02466997

CHUBX 2012/05

Details and patient eligibility

About

Multicentric French parallel double-blind randomized versus placebo study

Full 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

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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42 participants in 2 patient groups, including a placebo group

Tacrolimus group

Experimental group

Description:

Target-lesion will be treated with the study treatment BID. The batch of treatment (Tacrolimus ointment 0.1% or placebo) will be randomized. All the patients will be treated during 6 months. Counselling on natural daylight exposition will also be given to all patients. During the 6-month observation period, relapse (worsening of VASI ≥ 25%) will be re-treated by the study treatment

Treatment:

Drug: tacrolimus

Control group

Placebo Comparator group

Description:

In the Control group, patients will receive the placebo ointment to be applied twice a day during 24 weeks. Counselling on natural light exposure during the duration of the trial will be given.

Treatment:

Drug: Placebo