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Efficacy and Safety of Pimecrolimus for the Treatment of Vitiligo Vulgaris

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00372307
First Posted: September 6, 2006
Last Update Posted: December 28, 2007
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.
Collaborator:
Novartis
Information provided by:
University Hospital, Ghent
  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
Intervention Model: Single Group Assignment
Masking: None (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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: September 4, 2006
First Posted: September 6, 2006
Last Update Posted: December 28, 2007
Last Verified: December 2007

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
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action