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

Primary Purpose

Vitiligo

Status
Completed
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
topical tacrolimus treatment
topical pimecrolimus treatment
local mometasone furoate treatment
cold cream
Sponsored by
University Hospital, Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitiligo focused on measuring vitiligo

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital Ghent

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

topical tacrolimus

topical pimecrolimus

local steroids

cold cream

Arm Description

Outcomes

Primary Outcome Measures

percentage of skin pigmentation in the treated area
digital image analysis system for surface measurement

Secondary Outcome Measures

Full Information

First Posted
February 26, 2010
Last Updated
December 7, 2022
Sponsor
University Hospital, Ghent
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1. Study Identification

Unique Protocol Identification Number
NCT01082393
Brief Title
Vitiligo and the Koebner Phenomenon (Model of Vitiligo Induction and Therapy: a Clinical and Immunological Analysis)
Acronym
Koebner
Official Title
Vitiligo and the Koebner Phenomenon (Model of Vitiligo Induction and Therapy: a Clinical and Immunological Analysis)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
February 16, 2010 (Actual)
Primary Completion Date
September 15, 2015 (Actual)
Study Completion Date
December 1, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitiligo
Keywords
vitiligo

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
topical tacrolimus
Arm Type
Active Comparator
Arm Title
topical pimecrolimus
Arm Type
Active Comparator
Arm Title
local steroids
Arm Type
Active Comparator
Arm Title
cold cream
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
topical tacrolimus treatment
Intervention Description
4 applications (day 1,day 3, day 6 and day10)
Intervention Type
Drug
Intervention Name(s)
topical pimecrolimus treatment
Intervention Description
4 applications (day 1, day 3, day 6 and day 10)
Intervention Type
Drug
Intervention Name(s)
local mometasone furoate treatment
Intervention Description
4 applications (day 1, day 3, day 6 and day 10)
Intervention Type
Drug
Intervention Name(s)
cold cream
Intervention Description
4 applications (day 1, day 3, day 6 and day 10)
Primary Outcome Measure Information:
Title
percentage of skin pigmentation in the treated area
Description
digital image analysis system for surface measurement
Time Frame
after 1 day, 10 days, 30 days and 60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nanny Van Geel, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
Country
Belgium

12. IPD Sharing Statement

Links:
URL
http://www.uzgent.be
Description
website University Hospital Ghent

Learn more about this trial

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

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