Vitiligo Treated With TL01 Combined With Tacrolimus Ointment Versus Placebo

Vitiligo Clinical Trial

Official title:

Treatment of Vitiligo With Narrowband UVB (TL01) Combined With Tacrolimus (0.1%) Versus Placebo Ointment, a Randomized Right/Left Double Blind Comparative Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00807690
• Other study ID #: 182-04066
• Status: Completed
• Phase: Phase 3
• First received: December 11, 2008
• Last updated: December 11, 2008
• Start date: November 2005
• Est. completion date: January 2008

Study information

• Verified date: December 2008
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vitiligo

Intervention

Drug:
• Tacrolimus ointment
Tacrolimus ointment 0.1%every night for at least 3 months, half body side

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital