Vitiligo and the Koebner Phenomenon (Model of Vitiligo Induction and Therapy: a Clinical and Immunological Analysis) (Koebner)

December 7, 2022 updated by: University Hospital, Ghent
We will investigate the process of vitiligo induction and the influence of different commonly used cream treatments on this process. Studies comparing different treatments for vitiligo in the induction stage of the disease are still missing. The study hypothesis = cream treatment can stop actively spreading vitiligo lesions during the early induction stage of the disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Ghent, Belgium
        • University Hospital Ghent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female,
  • Age 18-70 years,
  • Extensive vitiligo (> 50% body surface area),
  • Patients asking for depigmenting therapy,
  • Not pregnant.

Exclusion Criteria:

  • Children,
  • Non extensive vitiligo (< 50% boy surface area),
  • Patients not asking for depigmenting therapies,
  • Pregnant.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: topical tacrolimus
Drug: topical tacrolimus treatment
4 applications (day 1,day 3, day 6 and day10)
Active Comparator: topical pimecrolimus
Drug: topical pimecrolimus treatment
4 applications (day 1, day 3, day 6 and day 10)
Active Comparator: local steroids
Drug: local mometasone furoate treatment
4 applications (day 1, day 3, day 6 and day 10)
Placebo Comparator: cold cream
Drug: cold cream
4 applications (day 1, day 3, day 6 and day 10)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
percentage of skin pigmentation in the treated area
Time Frame: after 1 day, 10 days, 30 days and 60 days
digital image analysis system for surface measurement
after 1 day, 10 days, 30 days and 60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Ghent

Investigators

  • Principal Investigator: Nanny Van Geel, MD, PhD, University Hospital, Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2010

Primary Completion (Actual)

September 15, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

February 26, 2010

First Submitted That Met QC Criteria

March 5, 2010

First Posted (Estimate)

March 8, 2010

Study Record Updates

Last Update Posted (Estimate)

December 8, 2022

Last Update Submitted That Met QC Criteria

December 7, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009/599

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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