Efficacy and Safety of Pimecrolimus for the Treatment of Vitiligo Vulgaris

Phase 2

Completed

• Conditions: Vitiligo Vulgaris

• Registration Number: NCT00372307
• Lead Sponsor: University Hospital, Ghent

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-05
• Study Completion: 2004-11
• Study First Submitted: 2006-09-04
• Study First Submitted QC: 2006-09-04
• Study First Posted: 2006-09-06
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-19
• Last Update Posted: 2007-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Repigmentation percentage of the reference lesion after 6 months.

Secondary Outcome Measures

Name	Time	Method
Number of patients with repigmentation after 3 and 6 months.
Repigmentation percentage of the reference lesion after 3 months.
Adverse events (month 3 and 6).

Trial Locations

Locations (1)

University Hospital Ghent; 🇧🇪 Ghent, Belgium