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CompletedNCT00372307Updated Dec 28, 2007

Efficacy and Safety of Pimecrolimus for the Treatment of Vitiligo Vulgaris

A Phase 2 interventional study of Application of pimecrolimus in Vitiligo Vulgaris, sponsored by University Hospital, Ghent. Completed at 1 site in Belgium. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2007-12-28.

Sponsored by University Hospital, Ghent · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
26
Allocation
Non-randomized
Ages
6 Years and older
Sex
All
01

Study summary

Patients with vitiligo vulgaris are treated with Pimecrolimus twice a day during 6 months. After a baseline visit, patient returns for a control visit after 3 and 6 months of treatment. One reference lesion is clinically evaluated with pictures.

02

Conditions studied

  • Vitiligo Vulgaris

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03

In context

Vitiligo

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

This study's enrollment of 26 is below the median of 32 across 235 interventional studies indexed under Vitiligo.

Browse Vitiligo studies →

Lead sponsor

University Hospital, Ghent is the lead sponsor of 685 studies on the registry; 158 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

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

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Active or stable vitiligo vulgaris
  • lesions at head or neck + maximum 10% lesions at the rest of the body

Exclusion criteria

Exclusion Criteria:

  • Topica during last 2 weeks
  • Photo(chemo)therapy during last 4 weeks
  • Segmentary vitiligo
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
26 participants

Interventions

  • DrugApplication of pimecrolimus
06

What researchers measure

Primary outcomes

  1. Repigmentation percentage of the reference lesion after 6 months.

Secondary outcomes

  1. Number of patients with repigmentation after 3 and 6 months.

  2. Repigmentation percentage of the reference lesion after 3 months.

  3. Adverse events (month 3 and 6).

07

Study locations

1 site
  • University Hospital Ghent
    Ghent, 9000, Belgium
08

References and documents

Publications

  • Boone B, Ongenae K, Van Geel N, Vernijns S, De Keyser S, Naeyaert JM. Topical pimecrolimus in the treatment of vitiligo. Eur J Dermatol. 2007 Jan-Feb;17(1):55-61. doi: 10.1684/ejd.2007.0093. Epub 2007 Feb 27. PubMed 17324829 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2004 and a completion of Nov 2004. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 4, 2006
First posted
Sep 6, 2006
Start
May 2004
CompletionActual
Nov 2004
Last update
Dec 28, 2007
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 28, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00372307
Lead sponsor
University Hospital, Ghent
Collaborators
Novartis
First posted
Sep 6, 2006
Start date
May 2004
Completion
Nov 2004
Last update
Dec 28, 2007

Study contacts

Jean-Marie Naeyaert, MD, PhD
principal investigator · University Hospital, Ghent

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2007. You cannot join it, but the record below documents what was studied.

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Discussion

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