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

Study Overview
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Brief Summary
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Multicentric French parallel double-blind randomized versus placebo study

Detailed Description
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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

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

Conditions
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Vitiligo

Intervention / Treatment
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* Drug: tacrolimus
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject male or female with age over 18 years old Diagnosis of non-segmental (symmetrical) vitiligo 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) Subject affiliated to the French social security system Exclusion Criteria: Progressive vitiligo over the last 3 months Spontaneous ongoing repigmentation (documented in the last 3 months) Previous topical Tacrolimus treatment in the last 3 months 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 Underlying dermatological disease (i.e.: history of atopic dermatitis, eczema, psoriasis), which, according to the investigator, could interfere with the study assessments Known sensitivity to study drug or macrolides Past history of skin cancer or lymphoma Congenital or acquired immunodeficiency Pregnant or breastfeeding women Women without contraception Absence of signed informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tacrolimus group<br>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 | Drug: tacrolimus<br>* 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<br>* Other names: Protopic;|
| Placebo Comparator: Control group<br>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. | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of repigmented surface area of the target lesion ≥75% | 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. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation in percentage of repigmented surface area | 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) | 24 weeks | 
| Variation in percentage of repigmented surface area | 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) | 48 weeks | 
| Variation of patient's global satisfaction using Likert score | Variation of patient's global satisfaction using Likert score at each follow-up visit | 12 weeks | 
| Variation of patient's global satisfaction using Likert score | Variation of patient's global satisfaction using Likert score at each follow-up visit | 24 weeks | 
| Variation of patient's global satisfaction using Likert score | Variation of patient's global satisfaction using Likert score at each follow-up visit | 48 weeks | 
| Variation of the physician global evaluation of treatment efficacy | Variation of the physician global evaluation of treatment efficacy on facial vitiligo using Likert score at each follow-up visit | 12 weeks | 
| Variation of the physician global evaluation of treatment efficacy | Variation of the physician global evaluation of treatment efficacy on facial vitiligo using Likert score at each follow-up visit. | 24 weeks | 
| Variation of the physician global evaluation of treatment efficacy | Variation of the physician global evaluation of treatment efficacy on facial vitiligo using Likert score at each follow-up visit. | 48 weeks | 
| Variation of the Dermatology Life Quality Index | Variation of the Dermatology Life Quality Index (DLQI) between inclusion and after 24 weeks of treatment between the 2 groups | 24 weeks | 
| Number of participants with Adverse events |  | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitiligo, Tacrolimus, Face