Skip to main content
OpenTrials
Completed

NCT Number: NCT02466997

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

Multicentric French parallel double-blind randomized versus placebo study

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Vitiligo Disease Attributes Facies Hypopigmentation Pathologic Processes Pathological Conditions, Signs and Symptoms Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Hospital of Bordeaux - St André Hospital, Bordeaux, France

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tacrolimus

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

Other names: Protopic

Placebo

Drug

Primary outcomes

  1. Percentage of repigmented surface area of the target lesion ≥75%

    Time frame: 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 outcomes

  1. Variation in percentage of repigmented surface area

    Time frame: 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)

  2. Variation in percentage of repigmented surface area

    Time frame: 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)

  3. Variation of patient's global satisfaction using Likert score

    Time frame: 12 weeks

    Variation of patient's global satisfaction using Likert score at each follow-up visit

  4. Variation of patient's global satisfaction using Likert score

    Time frame: 24 weeks

    Variation of patient's global satisfaction using Likert score at each follow-up visit

  5. Variation of patient's global satisfaction using Likert score

    Time frame: 48 weeks

    Variation of patient's global satisfaction using Likert score at each follow-up visit

  6. Variation of the physician global evaluation of treatment efficacy

    Time frame: 12 weeks

    Variation of the physician global evaluation of treatment efficacy on facial vitiligo using Likert score at each follow-up visit

  7. Variation of the physician global evaluation of treatment efficacy

    Time frame: 24 weeks

    Variation of the physician global evaluation of treatment efficacy on facial vitiligo using Likert score at each follow-up visit.

  8. Variation of the physician global evaluation of treatment efficacy

    Time frame: 48 weeks

    Variation of the physician global evaluation of treatment efficacy on facial vitiligo using Likert score at each follow-up visit.

  9. Variation of the Dermatology Life Quality Index

    Time frame: 24 weeks

    Variation of the Dermatology Life Quality Index (DLQI) between inclusion and after 24 weeks of treatment between the 2 groups

  10. Number of participants with Adverse events

    Time frame: 24 weeks

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

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

Acronym: VITAC

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jun 9, 2015
Registry last updated
Apr 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.