Overview

Vitiligo Treated With TL01 Combined With Tacrolimus Ointment Versus Placebo

Status:
Completed

Trial end date:
2008-01-01

Target enrollment:
0

Participant gender:
All

Summary

BACKGROUND Vitiligo is a common, often distressing condition. Many of the patients do not achieve sufficient effect from what is regarded as the treatment of choice at present, narrow band(NB)UVB(Tl01). There are reports on some patients partly successfully treated with Tacrolimus ointment. AIM OF THE STUDY We want to study whether Tacrolimus ointment may give an additive effect on symmetric vitiligo in combination with NB-UVB. METHODS This is a double blind left/right comparative study with 6 months treatment time. Patients are treated with whole body NB-UVB x 2 or x 3 weekly, in addition to Tacrolimus ointment versus placebo every night on affected half body sites. To measure effects we use photodocumentation in addition to morphometric registration of symmetric target lesions every 6 weeks.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Oslo University Hospital

Treatments:

Tacrolimus

Criteria

Inclusion Criteria:

- Patients aged at least 18 years with a stable, symmetric vitiligo

Exclusion Criteria:

- Patients with segmental vitiligo, aged < 18 years, known hypersensitivity to
Tacrolimus, pregnant or breastfeeding women