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Efficacy and Safety of Pimecrolimus for the Treatment of Vitiligo Vulgaris

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00372307
First received: September 4, 2006
Last updated: December 19, 2007
Last verified: December 2007
History of Changes
  Purpose

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.


Condition Intervention Phase
Vitiligo Vulgaris
 Drug: Application of pimecrolimus
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Pimecrolimus for the Treatment of Vitiligo Vulgaris

Resource links provided by NLM:

MedlinePlus related topics: Vitiligo
U.S. FDA Resources

Further study details as provided by University Hospital, Ghent:

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).

Estimated Enrollment: 26
Study Start Date: May 2004
Study Completion Date: November 2004
  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00372307

Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Novartis
Investigators
Principal Investigator: Jean-Marie Naeyaert, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
Website of the University Hospital Ghent  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT00372307     History of Changes
Other Study ID Numbers: 2003/275
Study First Received: September 4, 2006
Last Updated: December 19, 2007
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases
Pimecrolimus
Tacrolimus
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 22, 2013