Vitiligo Treated With TL01 Combined With Tacrolimus Ointment Versus Placebo
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|ClinicalTrials.gov Identifier: NCT00807690|
Recruitment Status : Completed
First Posted : December 12, 2008
Last Update Posted : December 12, 2008
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|
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Parallel Assignment|
|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|
- Drug: Tacrolimus ointment
Tacrolimus ointment 0.1%every night for at least 3 months, half body side
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
|Principal Investigator:||Eli Johanne Nordal, MD||Rikshospitalet HF, Dept. of Dermatology|