Vitiligo Treated With TL01 Combined With Tacrolimus Ointment Versus Placebo

Phase 3

Completed

• Conditions: Vitiligo

• Registration Number: NCT00807690
• Lead Sponsor: Oslo University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-11
• Study Completion: 2008-01
• Status Verified: 2008-12
• Study First Submitted: 2008-12-11
• Study First Submitted QC: 2008-12-11
• Last Update Submitted: 2008-12-11
• Study First Posted: 2008-12-12
• Last Update Posted: 2008-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL