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

Phase 3

Completed

• Conditions: Vitiligo
• Interventions: Drug: Placebo; Drug: tacrolimus

• Registration Number: NCT02466997
• Lead Sponsor: University Hospital, Bordeaux

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

Study Timeline

• Study First Submitted: 2015-05-26
• Study First Submitted QC: 2015-06-08
• Study First Posted: 2015-06-09
• Study Start: 2016-02-23
• Primary Completion: 2018-09-30
• Study Completion: 2018-09-30
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-16
• Last Update Posted: 2021-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Placebo	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.
Tacrolimus group	tacrolimus	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Variation in percentage of repigmented surface area	48 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	48 weeks	Variation of patient's global satisfaction using Likert score at each follow-up visit
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 of the physician global evaluation of treatment efficacy	48 weeks	Variation of the physician global evaluation of treatment efficacy on facial vitiligo using Likert score at each follow-up visit.

Trial Locations

Locations (4)

University Hospital of Bordeaux - St André Hospital; 🇫🇷 Bordeaux, France

Regional Hospital Center of Le Mans -; 🇫🇷 Le Mans, France

University Hospital Center of Nice - Hôpital de l'Archet; 🇫🇷 Nice, France

University Hospital Center of Rennes - Hôpital Pontchaillou; 🇫🇷 Rennes, France