Status:
TERMINATED
Maintenance Treatment of Non Segmental Vitiligo With Tacrolimus Ointment 0.1% Versus Control
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Conditions:
Pigmentation Disorders
Vitiligo
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 mainte...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01841008
Start Date
December 1 2011
End Date
June 1 2014
Last Update
September 5 2014
Active Locations (2)
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1
CHU de Nice - Hôpital de l'Archet
Nice, Alpes-Maritimes, France, 06200
2
CHU de Bordeaux
Bordeaux, Gironde, France, 33 404