Back to resultsEfficacy of Tacrolimus in Adults With Facial Non-segmental Vitiligo - VITAC (VITAC)
Primary Purpose
Vitiligo
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
tacrolimus
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Vitiligo focused on measuring Vitiligo, Tacrolimus, Face
Eligibility Criteria
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
Sites / Locations
- University Hospital of Bordeaux - St André Hospital
- Regional Hospital Center of Le Mans -
- University Hospital Center of Nice - Hôpital de l'Archet
- University Hospital Center of Rennes - Hôpital Pontchaillou
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Tacrolimus group
Control group
Arm Description
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
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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)
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)
Variation of patient's global satisfaction using Likert score
Variation of patient's global satisfaction using Likert score at each follow-up visit
Variation of patient's global satisfaction using Likert score
Variation of patient's global satisfaction using Likert score at each follow-up visit
Variation of patient's global satisfaction using Likert score
Variation of patient's global satisfaction using Likert score at each follow-up visit
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
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.
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.
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
Number of participants with Adverse events
Full Information
NCT ID
NCT02466997
First Posted
May 26, 2015
Last Updated
April 16, 2021
Sponsor
University Hospital, Bordeaux
1. Study Identification
Unique Protocol Identification Number
NCT02466997
Brief Title
Efficacy of Tacrolimus in Adults With Facial Non-segmental Vitiligo - VITAC
Acronym
VITAC
Official Title
Efficacy of Tacrolimus Ointment 0.1% Versus Placebo in Adults With Facial Non-segmental Vitiligo: a Randomized Double-blind Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
February 23, 2016 (Actual)
Primary Completion Date
September 30, 2018 (Actual)
Study Completion Date
September 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Multicentric French parallel double-blind randomized versus placebo study
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo
Keywords
Vitiligo, Tacrolimus, Face
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tacrolimus group
Arm Type
Experimental
Arm Description
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
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
tacrolimus
Other Intervention Name(s)
Protopic
Intervention Description
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
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Percentage of repigmented surface area of the target lesion ≥75%
Description
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.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Variation in percentage of repigmented surface area
Description
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)
Time Frame
24 weeks
Title
Variation in percentage of repigmented surface area
Description
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)
Time Frame
48 weeks
Title
Variation of patient's global satisfaction using Likert score
Description
Variation of patient's global satisfaction using Likert score at each follow-up visit
Time Frame
12 weeks
Title
Variation of patient's global satisfaction using Likert score
Description
Variation of patient's global satisfaction using Likert score at each follow-up visit
Time Frame
24 weeks
Title
Variation of patient's global satisfaction using Likert score
Description
Variation of patient's global satisfaction using Likert score at each follow-up visit
Time Frame
48 weeks
Title
Variation of the physician global evaluation of treatment efficacy
Description
Variation of the physician global evaluation of treatment efficacy on facial vitiligo using Likert score at each follow-up visit
Time Frame
12 weeks
Title
Variation of the physician global evaluation of treatment efficacy
Description
Variation of the physician global evaluation of treatment efficacy on facial vitiligo using Likert score at each follow-up visit.
Time Frame
24 weeks
Title
Variation of the physician global evaluation of treatment efficacy
Description
Variation of the physician global evaluation of treatment efficacy on facial vitiligo using Likert score at each follow-up visit.
Time Frame
48 weeks
Title
Variation of the Dermatology Life Quality Index
Description
Variation of the Dermatology Life Quality Index (DLQI) between inclusion and after 24 weeks of treatment between the 2 groups
Time Frame
24 weeks
Title
Number of participants with Adverse events
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khaled EZZEDINE
Organizational Affiliation
University Hospital Bordeaux, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Bordeaux - St André Hospital
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Regional Hospital Center of Le Mans -
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
University Hospital Center of Nice - Hôpital de l'Archet
City
Nice
ZIP/Postal Code
06000
Country
France
Facility Name
University Hospital Center of Rennes - Hôpital Pontchaillou
City
Rennes
ZIP/Postal Code
35000
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
33549606
Citation
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.
Results Reference
derived
Learn more about this trial
Efficacy of Tacrolimus in Adults With Facial Non-segmental Vitiligo - VITAC
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