Vitiligo Treated With TL01 Combined With Tacrolimus Ointment Versus Placebo - Full Text View

Sponsored by:	Rikshospitalet HF
Information provided by:	Rikshospitalet HF
ClinicalTrials.gov Identifier:	NCT00807690

Purpose

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.

Condition	Intervention	Phase
Vitiligo	Drug: Tacrolimus ointment	Phase III

MedlinePlus related topics: Vitiligo

Drug Information available for: Tacrolimus Tacrolimus anhydrous

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
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

Further study details as provided by Rikshospitalet HF:

Study Start Date:	November 2005
Study Completion Date:	January 2008

Intervention Details:

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00807690

Sponsors and Collaborators

Rikshospitalet HF

Investigators

Principal Investigator:

Eli Johanne Nordal, MD

Rikshospitalet HF, Dept. of Dermatology

More Information

Responsible Party:	Rikshospitalet HF ( Eli Johanne Nordal/senior consultant )
Study ID Numbers:	182-04066
Study First Received:	December 11, 2008
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00807690
Health Authority:	Norway: The National Committees for Research Ethics in Norway

Keywords provided by Rikshospitalet HF:

vitiligo
tacrolimus ointment 0.1%
narrowband UVB (TL01)

Study placed in the following topic categories:

Hypopigmentation
Skin Diseases
Pigmentation Disorders

Hypomelanotic disorder
Tacrolimus
Vitiligo

Additional relevant MeSH terms:

Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009