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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
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 October 19, 2014