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Efficacy and Safety of Pimecrolimus for the Treatment of Vitiligo Vulgaris

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00372307
Recruitment Status : Completed
First Posted : September 6, 2006
Last Update Posted : December 28, 2007
Sponsor:
Collaborator:
Novartis
Information provided by:
University Hospital, Ghent

Tracking Information
First Submitted Date  ICMJE September 4, 2006
First Posted Date  ICMJE September 6, 2006
Last Update Posted Date December 28, 2007
Study Start Date  ICMJE May 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 6, 2006)
Repigmentation percentage of the reference lesion after 6 months.
Original Primary Outcome Measures  ICMJE
 (submitted: September 4, 2006)
Repigmentation percentage of the reference laesie after 6 months.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 6, 2006)
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: September 4, 2006)
  • Number of patients with repigmentation after 3 and 6 months.
  • Repigmentation percentage of the reference laesie after 3 months.
  • Adverse events (month 3 and 6).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Pimecrolimus for the Treatment of Vitiligo Vulgaris
Official Title  ICMJE Efficacy and Safety of Pimecrolimus for the Treatment of Vitiligo Vulgaris
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Vitiligo Vulgaris
Intervention  ICMJE Drug: Application of pimecrolimus
Study Arms  ICMJE Not Provided
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. Epub 2007 Feb 27. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 4, 2006)
26
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00372307
Other Study ID Numbers  ICMJE 2003/275
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE University Hospital, Ghent
Collaborators  ICMJE Novartis
Investigators  ICMJE
Principal Investigator: Jean-Marie Naeyaert, MD, PhD University Hospital, Ghent
PRS Account University Hospital, Ghent
Verification Date December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP