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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 : Unknown
Verified March 2016 by University Hospital, Bordeaux.
Recruitment status was:  Recruiting
First Posted : June 9, 2015
Last Update Posted : March 10, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief Summary:
Multicentric French parallel double-blind randomized versus placebo study

Condition or disease Intervention/treatment Phase
Vitiligo Drug: tacrolimus Drug: Placebo Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Tacrolimus Ointment 0.1% Versus Placebo in Adults With Facial Non-segmental Vitiligo: a Randomized Double-blind Controlled Study
Study Start Date : July 2015
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitiligo
Drug Information available for: Tacrolimus

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 Name: 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



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02466997


Contacts
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Contact: Khaled EZZEDINE 33.5.56.79.47.05 khaled.ezzedine@chu-bordeaux.fr
Contact: Nicolas ANDREU 33.5.57.82.06.55 nicolas.andreu@chu-bordeaux.fr

Locations
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France
University Hospital of Bordeaux - St André Hospital Recruiting
Bordeaux, France, 33000
Contact: Julien SENESCHAL, MD, PhD    +335.56.79.47.05    juline.seneschal@chu-bordeaux.fr   
Contact: Nicolas ANDREU    +335 57 82 06 55    nicolas.andreu@chu-bordeaux.fr   
Regional Hospital Center of Le Mans - Not yet recruiting
Le Mans, France, 72000
Contact: Hervé MAILLARD, MD    +332 43 43 43 58    hmaillard@ch-lemans.fr   
University Hospital Center of Nice - Hôpital de l'Archet Not yet recruiting
Nice, France, 06000
Contact: Thierry PASSERON, MD    +334 92 03 64 88    passeron.t@chu-nice.fr   
University Hospital Center of Reims - Hôpital Robert Debre Not yet recruiting
Reims, France, 51000
Contact: Ziad REGUIAI, MD    +333 26 78 43 52    zreguiai.chu-reims@medical51.apicrypt.org   
University Hospital Center of Rennes - Hôpital Pontchaillou Not yet recruiting
Rennes, France, 35000
Contact: Catherine DROITCOURT    +332 99 28 43 49    catherine.droitcourt@chu-rennes.fr   
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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Principal Investigator: Khaled EZZEDINE University Hospital Bordeaux, France

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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT02466997     History of Changes
Other Study ID Numbers: CHUBX 2012/05
First Posted: June 9, 2015    Key Record Dates
Last Update Posted: March 10, 2016
Last Verified: March 2016
Keywords provided by University Hospital, Bordeaux:
Vitiligo
Tacrolimus
Face
Additional relevant MeSH terms:
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Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action