Efficacy of Tacrolimus in Adults With Facial Non-segmental Vitiligo

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-23

Study Completion Date

2018-09-30

Brief Summary

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Multicentric French parallel double-blind randomized versus placebo study

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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

Conditions

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Vitiligo

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Tacrolimus group

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

Group Type EXPERIMENTAL

tacrolimus

Intervention Type DRUG

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

Control group

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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tacrolimus

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

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Protopic

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No