Maintenance Treatment of Non Segmental Vitiligo With Tacrolimus Ointment 0.1% Versus Control
Status:
Terminated
Trial end date:
2014-06-01
Target enrollment:
Participant gender:
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.