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

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ClinicalTrials.gov Identifier: NCT02466997
Recruitment Status : Completed
First Posted : June 9, 2015
Last Update Posted : April 19, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Tracking Information
First Submitted Date  ICMJE May 26, 2015
First Posted Date  ICMJE June 9, 2015
Last Update Posted Date April 19, 2021
Actual Study Start Date  ICMJE February 23, 2016
Actual Primary Completion Date September 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2015)
  • 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)
  • 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)
  • 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
  • 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
  • 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
  • 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
  • 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.
  • 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.
  • 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
  • Number of participants with Adverse events [ Time Frame: 24 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Tacrolimus in Adults With Facial Non-segmental Vitiligo - VITAC
Official Title  ICMJE Efficacy of Tacrolimus Ointment 0.1% Versus Placebo in Adults With Facial Non-segmental Vitiligo: a Randomized Double-blind Controlled Study
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Vitiligo
Intervention  ICMJE
  • 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 Name: Protopic
  • Drug: Placebo
Study Arms  ICMJE
  • 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
    Intervention: Drug: tacrolimus
  • 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.

    Intervention: Drug: Placebo
Publications * Seneschal J, Duplaine A, Maillard H, Passeron T, Andreu N, Lassalle R, Favary C, Droitcourt C, Taïeb 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 Feb 4. pii: S0022-202X(21)00077-4. doi: 10.1016/j.jid.2020.12.028. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 16, 2021)
42
Original Estimated Enrollment  ICMJE
 (submitted: June 8, 2015)
100
Actual Study Completion Date  ICMJE September 30, 2018
Actual Primary Completion Date September 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02466997
Other Study ID Numbers  ICMJE CHUBX 2012/05
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Bordeaux
Study Sponsor  ICMJE University Hospital, Bordeaux
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Khaled EZZEDINE University Hospital Bordeaux, France
PRS Account University Hospital, Bordeaux
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP