Back to resultsVitiligo Treated With TL01 Combined With Tacrolimus Ointment Versus Placebo
Primary Purpose
Vitiligo
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Tacrolimus ointment
Sponsored by
About this trial
This is an interventional treatment trial for Vitiligo focused on measuring vitiligo, tacrolimus ointment 0.1%, narrowband UVB (TL01)
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00807690
First Posted
December 11, 2008
Last Updated
December 11, 2008
Sponsor
Oslo University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00807690
Brief Title
Vitiligo Treated With TL01 Combined With Tacrolimus Ointment Versus Placebo
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 Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Oslo University Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo
Keywords
vitiligo, tacrolimus ointment 0.1%, narrowband UVB (TL01)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Tacrolimus ointment
Intervention Description
Tacrolimus ointment 0.1%every night for at least 3 months, half body side
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eli Johanne Nordal, MD
Organizational Affiliation
Rikshospitalet HF, Dept. of Dermatology
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Vitiligo Treated With TL01 Combined With Tacrolimus Ointment Versus Placebo
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