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CompletedNCT00807690Updated Dec 12, 2008

Vitiligo Treated With TL01 Combined With Tacrolimus Ointment Versus Placebo

A Phase 3 interventional study of Tacrolimus ointment in Vitiligo, sponsored by Oslo University Hospital. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-12-12.

Sponsored by Oslo University Hospital · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Vitiligo

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Keywords

  • vitiligo
  • tacrolimus ointment 0.1%
  • narrowband UVB (TL01)
03

In context

Vitiligo

298 studies on the registry are indexed under Vitiligo; 69 are open to participants now.

Browse Vitiligo studies →

Lead sponsor

Oslo University Hospital is the lead sponsor of 810 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Patients aged at least 18 years with a stable, symmetric vitiligo

Exclusion criteria

Exclusion Criteria:

  • Patients with segmental vitiligo, aged \< 18 years, known hypersensitivity to Tacrolimus, pregnant or breastfeeding women
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double

Interventions

  • DrugTacrolimus ointment

    Tacrolimus ointment 0.1%every night for at least 3 months, half body side

06

Study locations

No study locations are listed for this record.

07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 12, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00807690
Lead sponsor
Oslo University Hospital
First posted
Dec 12, 2008
Start date
Nov 2005
Completion
Jan 2008
Last update
Dec 12, 2008

Study contacts

Eli Johanne Nordal, MD
principal investigator · Rikshospitalet HF, Dept. of Dermatology
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2008. You cannot join it, but the record below documents what was studied.

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