NCT00807690

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Nov 2005

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 12, 2008

Completed
Last Updated

December 12, 2008

Status Verified

December 1, 2008

First QC Date

December 11, 2008

Last Update Submit

December 11, 2008

Conditions

Vitiligo

Keywords

vitiligotacrolimus ointment 0.1%narrowband UVB (TL01)

Interventions

Tacrolimus ointmentDRUG

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

HypopigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Eli Johanne Nordal, MD

    Rikshospitalet HF, Dept. of Dermatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 11, 2008

First Posted

December 12, 2008

Study Start

November 1, 2005

Study Completion

January 1, 2008

Last Updated

December 12, 2008

Record last verified: 2008-12