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Vitiligo Treated With TL01 Combined With Tacrolimus Ointment Versus Placebo

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. Identifier: NCT00807690
Recruitment Status : Completed
First Posted : December 12, 2008
Last Update Posted : December 12, 2008
Information provided by:
Oslo University Hospital

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.

Condition or disease Intervention/treatment Phase
Vitiligo Drug: Tacrolimus ointment Phase 3

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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
Study Start Date : November 2005
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Vitiligo
MedlinePlus related topics: Vitiligo
Drug Information available for: Tacrolimus

Intervention Details:
  • Drug: Tacrolimus ointment
    Tacrolimus ointment 0.1%every night for at least 3 months, half body side

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00807690

Sponsors and Collaborators
Oslo University Hospital
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Principal Investigator: Eli Johanne Nordal, MD Rikshospitalet HF, Dept. of Dermatology
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Responsible Party: Eli Johanne Nordal/senior consultant, Rikshospitalet HF Identifier: NCT00807690    
Other Study ID Numbers: 182-04066
First Posted: December 12, 2008    Key Record Dates
Last Update Posted: December 12, 2008
Last Verified: December 2008
Keywords provided by Oslo University Hospital:
tacrolimus ointment 0.1%
narrowband UVB (TL01)
Additional relevant MeSH terms:
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Pigmentation Disorders
Skin Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action