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Vitiligo Treated With TL01 Combined With Tacrolimus Ointment Versus Placebo

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00807690
First Posted: December 12, 2008
Last Update Posted: December 12, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Oslo University Hospital
December 11, 2008
December 12, 2008
December 12, 2008
November 2005
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No Changes Posted
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Vitiligo Treated With TL01 Combined With Tacrolimus Ointment Versus Placebo
Treatment of Vitiligo With Narrowband UVB (TL01) Combined With Tacrolimus (0.1%) Versus Placebo Ointment, a Randomized Right/Left Double Blind Comparative Study

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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Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Vitiligo
Drug: Tacrolimus ointment
Tacrolimus ointment 0.1%every night for at least 3 months, half body side
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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January 2008
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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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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NCT00807690
182-04066
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Eli Johanne Nordal/senior consultant, Rikshospitalet HF
Oslo University Hospital
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Principal Investigator: Eli Johanne Nordal, MD Rikshospitalet HF, Dept. of Dermatology
Oslo University Hospital
December 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP