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

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

Multicentric French parallel double-blind randomized versus placebo study

Study Overview

• Status: Completed
• Conditions: Vitiligo
• Intervention / Treatment: Drug: Placebo; Drug: tacrolimus

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 Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33000
    • University Hospital of Bordeaux - St André Hospital
  • Le Mans, France, 72000
    • Regional Hospital Center of Le Mans -
  • Nice, France, 06000
    • University Hospital Center of Nice - Hôpital de l'Archet
  • Rennes, France, 35000
    • University Hospital Center of Rennes - Hôpital Pontchaillou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Principal Investigator: Khaled EZZEDINE, University Hospital Bordeaux, France

Publications and helpful links

General Publications

• Seneschal J, Duplaine A, Maillard H, Passeron T, Andreu N, Lassalle R, Favary C, Droitcourt C, Taieb A, Ezzedine K. Efficacy and Safety of Tacrolimus 0.1% for the Treatment of Facial Vitiligo: A Multicenter Randomized, Double-Blinded, Vehicle-Controlled Study. J Invest Dermatol. 2021 Jul;141(7):1728-1734. doi: 10.1016/j.jid.2020.12.028. Epub 2021 Feb 4.

Helpful Links

• Publication

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2016
• Primary Completion (Actual): September 30, 2018
• Study Completion (Actual): September 30, 2018

Study Registration Dates

• First Submitted: May 26, 2015
• First Submitted That Met QC Criteria: June 8, 2015
• First Posted (Estimate): June 9, 2015

Study Record Updates

• Last Update Posted (Actual): April 19, 2021
• Last Update Submitted That Met QC Criteria: April 16, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Tacrolimus; Vitiligo; Face
• Additional Relevant MeSH Terms: Skin Diseases; Pigmentation Disorders; Hypopigmentation; Vitiligo; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Immunosuppressive Agents; Immunologic Factors; Calcineurin Inhibitors; Tacrolimus
• Other Study ID Numbers: CHUBX 2012/05