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Vitiligo Treated With TL01 Combined With Tacrolimus Ointment Versus Placebo

This study has been completed.
Sponsor:
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00807690
First received: December 11, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
  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-Blind
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:

MedlinePlus related topics: Vitiligo
Drug Information available for: Tacrolimus
U.S. FDA Resources

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

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

No publications provided

Responsible Party: Eli Johanne Nordal/senior consultant, Rikshospitalet HF
ClinicalTrials.gov Identifier: NCT00807690     History of Changes
Other Study ID Numbers: 182-04066
Study First Received: December 11, 2008
Last Updated: December 11, 2008
Health Authority: Norway:National Committee for Medical and Health Research Ethics

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013