Vitiligo Treated With TL01 Combined With Tacrolimus Ointment Versus Placebo

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2008-01-31

Brief Summary

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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

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Conditions

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Vitiligo

Keywords

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vitiligo tacrolimus ointment 0.1% narrowband UVB (TL01)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Tacrolimus ointment

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Rikshospitalet HF

Principal Investigators

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Eli Johanne Nordal, MD

Role: PRINCIPAL_INVESTIGATOR

Rikshospitalet HF, Dept. of Dermatology

Other Identifiers

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182-04066

Identifier Type: -

Identifier Source: org_study_id