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Efficacy and Safety of Pimecrolimus for the Treatment of Vitiligo Vulgaris

This study has been completed.
Information provided by:
University Hospital, Ghent Identifier:
First received: September 4, 2006
Last updated: December 19, 2007
Last verified: December 2007
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

Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00372307

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

Additional Information:
Publications: Identifier: NCT00372307     History of Changes
Other Study ID Numbers: 2003/275
Study First Received: September 4, 2006
Last Updated: December 19, 2007

Additional relevant MeSH terms:
Pigmentation Disorders
Skin Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
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 processed this record on September 19, 2017