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

• ClinicalTrials.gov Identifier: NCT01841008
• Recruitment Status: Terminated
• First Posted: April 26, 2013
• Last Update Posted: September 5, 2014
• Sponsor: Centre Hospitalier Universitaire de Nice
• Information provided by (Responsible Party): Centre Hospitalier Universitaire de Nice

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Pigmentation Disorders; Vitiligo	Drug: Protopic; Drug: Placebo : Diprobase	Phase 2; Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Maintenance Treatment of Non Segmental Vitiligo With Tacrolimus Ointment 0.1% Versus Control, Randomized and Double Blind Study
• Study Start Date: December 2011
• Actual Primary Completion Date: June 2013
• Actual Study Completion Date: June 2014

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. UV and direct light photographs [ Time Frame: At 6 months ]
   Comparison of photographs between day 0 and 24 weeks by two independent-blinded dermatologists

Secondary Outcome Measures :

1. Score of depigmentation, VASI score. Frequency and severity of adverse events. [ Time Frame: At 6 months ]
   Score of depigmentation, VASI score. Frequency and severity of adverse events.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

France

CHU de Nice - Hôpital de l'Archet

Nice, Alpes-Maritimes, France, 06200

CHU de Bordeaux

Bordeaux, Gironde, France, 33 404

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

• Responsible Party: Centre Hospitalier Universitaire de Nice
• ClinicalTrials.gov Identifier: NCT01841008 History of Changes
• Other Study ID Numbers: 11-PP-12
• First Posted: April 26, 2013
• Last Update Posted: September 5, 2014
• Last Verified: June 2014

Keywords provided by Centre Hospitalier Universitaire de Nice:

[C17.800.621]

Additional relevant MeSH terms:

Vitiligo; Pigmentation Disorders; Hypopigmentation; Skin Diseases; Pathologic Processes; Tacrolimus; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Calcineurin Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action