Back to resultsEfficacy and Safety of Pimecrolimus for the Treatment of Vitiligo Vulgaris
Primary Purpose
Vitiligo Vulgaris
Status
Completed
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
Application of pimecrolimus
Sponsored by
About this trial
This is an interventional treatment trial for Vitiligo Vulgaris
Eligibility Criteria
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
Sites / Locations
- University Hospital Ghent
Outcomes
Primary Outcome Measures
Repigmentation percentage of the reference lesion after 6 months.
Secondary Outcome 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).
Full Information
NCT ID
NCT00372307
First Posted
September 4, 2006
Last Updated
December 19, 2007
Sponsor
University Hospital, Ghent
Collaborators
Novartis
1. Study Identification
Unique Protocol Identification Number
NCT00372307
Brief Title
Efficacy and Safety of Pimecrolimus for the Treatment of Vitiligo Vulgaris
Official Title
Efficacy and Safety of Pimecrolimus for the Treatment of Vitiligo Vulgaris
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Ghent
Collaborators
Novartis
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo Vulgaris
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
26 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Application of pimecrolimus
Primary Outcome Measure Information:
Title
Repigmentation percentage of the reference lesion after 6 months.
Secondary Outcome Measure Information:
Title
Number of patients with repigmentation after 3 and 6 months.
Title
Repigmentation percentage of the reference lesion after 3 months.
Title
Adverse events (month 3 and 6).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Marie Naeyaert, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
17324829
Citation
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.
Results Reference
background
Links:
URL
http://www.uzgent.be
Description
Website of the University Hospital Ghent
Learn more about this trial
Efficacy and Safety of Pimecrolimus for the Treatment of Vitiligo Vulgaris
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