ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Vitiligo Vulgaris Drug: Application of pimecrolimus Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Interventional  (Clinical Trial)
Enrollment : 26 participants
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
Study Start Date : May 2004
Actual Study Completion Date : November 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitiligo

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Repigmentation percentage of the reference lesion after 6 months.

Secondary Outcome Measures :
  1. Number of patients with repigmentation after 3 and 6 months.
  2. Repigmentation percentage of the reference lesion after 3 months.
  3. Adverse events (month 3 and 6).

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
First Posted: September 6, 2006    Key Record Dates
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