Vitiligo Treated With TL01 Combined With Tacrolimus Ointment Versus Placebo

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.

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Key information

Conditions

Vitiligo Hypopigmentation Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tacrolimus ointment

Drug

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

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2005
Study completion: 2008
First posted: Dec 12, 2008
Registry last updated: Dec 12, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed