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

NCT ID: NCT01082393

Last Updated: 2022-12-08

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

PHASE4

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-16

Study Completion Date

2015-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Vitiligo

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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topical tacrolimus

Group Type ACTIVE_COMPARATOR

topical tacrolimus treatment

Intervention Type DRUG

4 applications (day 1,day 3, day 6 and day10)

topical pimecrolimus

Group Type ACTIVE_COMPARATOR

topical pimecrolimus treatment

Intervention Type DRUG

4 applications (day 1, day 3, day 6 and day 10)

local steroids

Group Type ACTIVE_COMPARATOR

local mometasone furoate treatment

Intervention Type DRUG

4 applications (day 1, day 3, day 6 and day 10)

cold cream

Group Type PLACEBO_COMPARATOR

cold cream

Intervention Type DRUG

4 applications (day 1, day 3, day 6 and day 10)

Interventions

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topical tacrolimus treatment

4 applications (day 1,day 3, day 6 and day10)

Intervention Type DRUG

topical pimecrolimus treatment

4 applications (day 1, day 3, day 6 and day 10)

Intervention Type DRUG

local mometasone furoate treatment

4 applications (day 1, day 3, day 6 and day 10)

Intervention Type DRUG

cold cream

4 applications (day 1, day 3, day 6 and day 10)

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nanny Van Geel, 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

Related Links

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http://www.uzgent.be

website University Hospital Ghent

Other Identifiers

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2009/599

Identifier Type: -

Identifier Source: org_study_id

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