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Maintenance Treatment of Non Segmental Vitiligo With Tacrolimus Ointment 0.1% Versus Control

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Centre Hospitalier Universitaire de Nice
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT01841008
First received: March 23, 2012
Last updated: April 23, 2013
Last verified: February 2013
  Purpose

Tacrolimus ointment 0.1% has shown promising results for treating vitiligo in many prospective studies. Prospective randomized studies versus placebo are required to confirm the hypothesis that maintenance treatment with two applications of tacrolimus ointment 0.1% per week can reduce relapses of non-segmental vitiligo lesions.

Main objective To assess the efficacy of maintenance therapy with topical tacrolimus vs placebo in the prevention of depigmentation in patients with vitiligo who responded to treatment.

Secondary objectives

  • Evaluate the efficacy of maintenance therapy with tacrolimus vs topical placebo to decrease the intensity of depigmentation in patients with vitiligo who responded to treatment.
  • To study the occurrence of possible adverse effects.

Length of the study Inclusion: 12 months Treatment: 6 months Follow-up: 6 months Total length of the study: 18 months

Intervention Multicentric prospective interventional randomized comparative study versus placebo.

  • Visit V0: Selection Information of the patient, control of inclusion and non inclusion criteria.
  • Visit V1: Control of inclusion and non inclusion criteria, patients signed informed consent. An initial clinical evaluation and photographs in direct sunlight and UV. Topical treatment (tacrolimus or placebo) will be delivered to the patient by the hospital pharmacy and should be applied twice per week (3 or 4 days apart) for 24 weeks.
  • Visit V2:

The patient will be reviewed after the end of treatment (24 weeks after the visit V1) for final evaluation. A clinical assessment will be made and photographs in the same way as the inclusion. Adverse reactions during treatment will be collected by the investigator (they will be noted as and when the patient in a notebook that will be presented at baseline).

The percentage of depigmentation will be evaluated in a blinded treatment of photographs by two reviewers. In case of disagreement, the opinion of a third appraiser will be required.

- End of study: After the end of the study patients will be supported via the usual care recommended for their condition.

Evaluation criteria

  • primary endpoint

    ---Percentage of patients at 24 weeks without depigmentation (depigmentation score = 0). A score of depigmentation from 0 to 2 will be used. A blind treatment evaluation of direct light and UV photographs will be made by two independent observers (dermatologists) between inclusion and after 24 weeks of treatment.

  • secondary endpoints

    ---- The efficiency to reduce the intensity of relapses will be evaluated using the score of depigmentation (rate of patients with a score of 0 or 1 in each group) and the VASI score (Appendix 4).

  • The frequency, severity and time of occurrence of adverse events are reported. Side effects are classified into grades according to WHO criteria.

Number of subject Considering that depigmentation occurs in more than 40% of patients during the 24 weeks of maintenance treatment and hoped that the proactive treatment will reduce the rate of depigmentation of 10%, a population of 26 patients per group will be necessary (taking into account 10% of patients lost to follow). The total number of patients to be included in the study will be 52.


Condition Intervention Phase
Pigmentation Disorders
Vitiligo
Drug: Protopic
Drug: Placebo : Diprobase
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Maintenance Treatment of Non Segmental Vitiligo With Tacrolimus Ointment 0.1% Versus Control, Randomized and Double Blind Study

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nice:

Primary Outcome Measures:
  • UV and direct light photographs [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
    Comparison of photographs between day 0 and 24 weeks by two independent-blinded dermatologists


Secondary Outcome Measures:
  • Score of depigmentation, VASI score. Frequency and severity of adverse events. [ Time Frame: At 6 months ] [ Designated as safety issue: No ]
    Score of depigmentation, VASI score. Frequency and severity of adverse events.


Estimated Enrollment: 50
Study Start Date: December 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tacrolimus ointment 0.1% Drug: Protopic
Topical treatment (tacrolimus or placebo) will be delivered to the patient by the hospital pharmacy and should be applied twice per week (3 or 4 days apart) for 24 weeks.
Placebo Comparator: Group Placebo Drug: Placebo : Diprobase
Topical treatment (tacrolimus or placebo) will be delivered to the patient by the hospital pharmacy and should be applied twice per week (3 or 4 days apart) for 24 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years
  • Non-segmental vitiligo repigmented more than 75% with treatment (any type of treatment is accepted: NB-UVB, PUVA, lamp or excimer laser at 308 nm, topical steroids, topical tacrolimus, graft). The total area treated plates during maintenance treatment should not exceed 10% of the total body surface area.
  • Affiliation to the Social Security
  • Informed consent signed by the patient

Exclusion Criteria:

  • Segmental Vitiligo
  • Pregnant or breastfeeding women (pregnancy test will be conducted); effective contraception will be maintained for the duration of the study.
  • Allergy to macrolide derivatives.
  • Exposure to UV or concomitant exposure to the sun without protective shield.
  • Concomitant immunosuppressive therapy or oral corticosteroids for topical (on the vitiligo lesions) or systemic
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01841008

Contacts
Contact: Passeron Thierry, PU-PH +33492039224 passeron.t@chu-nice.fr
Contact: Bailet Olivier bailet.o@chu-nice.fr

Locations
France
CHU de Nice - Hôpital de l'Archet Recruiting
Nice, Alpes-Maritimes, France, 06200
Contact: PASSERON Thierry, PU-PH       passeron.t@chu-nice.fr   
Contact: bailet Olivier       bailet.o@chu-nice.fr   
Principal Investigator: Passeron Thierry, Pu-PH         
CHU de Bordeaux Recruiting
Bordeaux, Gironde, France, 33 404
Contact: EZZEDINE Khaled, PHD       khaled.ezzedine@chu-bordeaux.fr   
Sub-Investigator: Ezzedine Khaled, phd         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Principal Investigator: PASSERON Thierry, Pu-Ph CHU de Nice - Service de Dermatologie - Hôpital de l'Archet - 151 Route de saint-antoine de ginestière 06200 Nice
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01841008     History of Changes
Other Study ID Numbers: 11-PP-12
Study First Received: March 23, 2012
Last Updated: April 23, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

Keywords provided by Centre Hospitalier Universitaire de Nice:
[C17.800.621]

Additional relevant MeSH terms:
Vitiligo
Pigmentation Disorders
Hypopigmentation
Skin Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 26, 2014