Efficacy and Safety of Pimecrolimus for the Treatment of Vitiligo Vulgaris

Vitiligo Vulgaris Clinical Trial

Official title:

Efficacy and Safety of Pimecrolimus for the Treatment of Vitiligo Vulgaris

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00372307
• Other study ID #: 2003/275
• Status: Completed
• Phase: Phase 2
• First received: September 4, 2006
• Last updated: December 19, 2007
• Start date: May 2004
• Est. completion date: November 2004

Study information

• Verified date: December 2007
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: November 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vitiligo
• Vitiligo Vulgaris

Intervention

Drug:
• Application of pimecrolimus

Locations

Country	Name	City	State
Belgium	University Hospital Ghent	Ghent

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Ghent	Novartis

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

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. Epub 2007 Feb 27. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Repigmentation percentage of the reference lesion after 6 months.
Secondary	Number of patients with repigmentation after 3 and 6 months.
Secondary	Repigmentation percentage of the reference lesion after 3 months.
Secondary	Adverse events (month 3 and 6).

External Links

•   Website of the University Hospital Ghent