Efficacy and Safety of Pimecrolimus for the Treatment of Vitiligo Vulgaris

NCT ID: NCT00372307

Last Updated: 2007-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2004-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Vitiligo Vulgaris

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Application of pimecrolimus

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role collaborator

University Hospital, Ghent

OTHER

Sponsor Role lead

Principal Investigators

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Jean-Marie Naeyaert, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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University Hospital Ghent

Ghent, , Belgium

Site Status

Countries

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Belgium

References

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Boone B, Ongenae K, Van Geel N, Vernijns S, De Keyser S, Naeyaert JM. Topical pimecrolimus in the treatment of vitiligo. Eur J Dermatol. 2007 Jan-Feb;17(1):55-61. doi: 10.1684/ejd.2007.0093. Epub 2007 Feb 27.

Reference Type BACKGROUND
PMID: 17324829 (View on PubMed)

Related Links

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http://www.uzgent.be

Website of the University Hospital Ghent

Other Identifiers

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2003/275

Identifier Type: -

Identifier Source: org_study_id