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

Sponsor

University Hospital, Bordeaux (Other)

Overall Status

Completed

CT.gov ID

NCT02466997

Collaborator

(none)

Enrollment

Locations

Arms

31.2

Actual Duration (Months)

10.5

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Multicentric French parallel double-blind randomized versus placebo study

Condition or Disease	Intervention/Treatment	Phase
Vitiligo	Drug: tacrolimus Drug: Placebo	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Feb 23, 2016

Actual Primary Completion Date :

Sep 30, 2018

Actual Study Completion Date :

Sep 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: 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 Other Names: Protopic
Placebo Comparator: 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.	Drug: Placebo

Arm

Intervention/Treatment

Experimental: 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

Drug: 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

Other Names:

Protopic

Placebo Comparator: 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.

Drug: Placebo

Outcome Measures

Primary Outcome Measures

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

Variation in percentage of repigmented surface area [24 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 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 [12 weeks]
Variation of patient's global satisfaction using Likert score at each follow-up visit
Variation of patient's global satisfaction using Likert score [24 weeks]
Variation of patient's global satisfaction using Likert score at each follow-up visit
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 physician global evaluation of treatment efficacy [12 weeks]
Variation of the physician global evaluation of treatment efficacy on facial vitiligo using Likert score at each follow-up visit
Variation of the physician global evaluation of treatment efficacy [24 weeks]
Variation of the physician global evaluation of treatment efficacy on facial vitiligo using Likert score at each follow-up visit.
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.
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	University Hospital of Bordeaux - St André Hospital	Bordeaux	France	33000
2	Regional Hospital Center of Le Mans -	Le Mans	France	72000
3	University Hospital Center of Nice - Hôpital de l'Archet	Nice	France	06000
4	University Hospital Center of Rennes - Hôpital Pontchaillou	Rennes	France	35000