NCT00372307

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2004

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 4, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 6, 2006

Completed
Last Updated

December 28, 2007

Status Verified

December 1, 2007

First QC Date

September 4, 2006

Last Update Submit

December 19, 2007

Conditions

Vitiligo Vulgaris

Outcome Measures

Primary Outcomes (1)

  • Repigmentation percentage of the reference lesion after 6 months.

Secondary Outcomes (3)

  • 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).

Interventions

Application of pimecrolimusDRUG

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Active or stable vitiligo vulgaris
  • lesions at head or neck + maximum 10% lesions at the rest of the body

You may not qualify if:

  • Topica during last 2 weeks
  • Photo(chemo)therapy during last 4 weeks
  • Segmentary vitiligo

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 17324829BACKGROUND

Related Links

MeSH Terms

Conditions

Vitiligo

Condition Hierarchy (Ancestors)

HypopigmentationPigmentation DisordersSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jean-Marie Naeyaert, MD, PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 4, 2006

First Posted

September 6, 2006

Study Start

May 1, 2004

Study Completion

November 1, 2004

Last Updated

December 28, 2007

Record last verified: 2007-12

Locations

BE(1)