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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
  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 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Study Start Date: November 2005
Study Completion Date: January 2008
Intervention Details:
    Drug: Tacrolimus ointment
    Tacrolimus ointment 0.1%every night for at least 3 months, half body side
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT00807690


Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: Eli Johanne Nordal, MD Rikshospitalet HF, Dept. of Dermatology
  More Information

Responsible Party: Eli Johanne Nordal/senior consultant, Rikshospitalet HF
ClinicalTrials.gov Identifier: NCT00807690     History of Changes
Other Study ID Numbers: 182-04066
First Submitted: December 11, 2008
First Posted: December 12, 2008
Last Update Posted: December 12, 2008
Last Verified: December 2008

Keywords provided by Oslo University Hospital:
vitiligo
tacrolimus ointment 0.1%
narrowband UVB (TL01)

Additional relevant MeSH terms:
Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases
Tacrolimus
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action