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

April 16, 2021 updated by: University Hospital, Bordeaux

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
One year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
24 weeks
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)
48 weeks
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
12 weeks
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
24 weeks
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
48 weeks
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
12 weeks
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.
24 weeks
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.
48 weeks
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
24 weeks
Number of participants with Adverse events
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Bordeaux

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Khaled EZZEDINE, University Hospital Bordeaux, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 23, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 26, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 9, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 19, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHUBX 2012/05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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