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...
Date First Received: September 4, 2006
Last Updated: December 19, 2007
Verified by: University Hospital, Ghent, December 2007
Clinical Trial Phase: Phase 2 | Start Date: May 2004
Overall Status: Completed
Estimated Enrollment: 26
Brief Summary
Official Title: “Efficacy and Safety of Pimecrolimus for the Treatment of Vitiligo Vulgaris”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Intervention(s) in this Clinical Trial
- Drug: Application of pimecrolimus
Outcome Measures for this Clinical Trial
Primary Measures
- Repigmentation percentage of the reference lesion after 6 months.
Secondary Measures
- 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).
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 6 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: University Hospital, Ghent
Overall Clinical Trial Officials and Contacts
Jean-Marie Naeyaert, MD, PhD Principal Investigator University Hospital, Ghent
Related Publications
References
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.
Additional Information
Information obtained from ClinicalTrials.gov on August 28, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00372307
Study ID Number: 2003/275
ClinicalTrials.gov Identifier: NCT00372307
Health Authority: Belgium: Institutional Review Board
Clinical Trials Authorship and Review
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