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Examination Of Vitiligo Skin Samples Before and After UVB Treatment

NCT ID: NCT00177034

Last Updated: 2012-07-10

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

TERMINATED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2005-12-31

Brief Summary

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The keratinocytes of lesional skin of vitiligo compared to normal and perilesional skin will differentially express genes correlating with melanocyte death. Narrow Band UVB should then hopefully reverse the pattern of gene expression back toward normal.

Detailed Description

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Vitiligo is a disease caused by the disappearance of melanocytes in the epidermis. The pathogenesis of vitiligo is multifactorial. Theories include autoimmunity, neural, apoptosis and cytotoxicity. The medical treatments for vitiligo are marginal with a 40-60% response rate which does not guarantee full repigmentation. Understanding the pathogenesis of vitiligo will allow better targets for treatment.

Previous analysis of skin biopsies have found several of the changes in gene expression occurred in immune regulation, DNA replication and repair, oncogenes, signal transducers and transcription factors. These results give us insight as to what happens in lesional vs nonlesional skin which contains the epidermis, dermis, fat, blood vessels and immune cells.

We have the technology today to study specific cell populations from tissue by the use of laser capture microdissection. We propose to use this technique to study the keratinocyte population in vitiligo skin because past evidence suggests that they may play a role. In addition, the role keratinocytes in vitiligo may be important for treatment as this would be the ideal target for therapy. Keratinocytes have been studied in vitiligo.

The aim of the study is to isolate keratinocytes from normal skin, perilesional and lesional skin in vitiligo patients by laser capture microdissection and characterize their gene expression profile by gene microarray analysis and to compare keratinocyte gene expression in normal, perilesional and lesional vitiligo skin before and after narrow band UVB treatment.

Conditions

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Vitiligo

Keywords

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Keratinocyte

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Narrow Band UVB Treatment

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Patients should have non-treated symmetrically active vitiligo for 3 months.

Exclusion Criteria

Less than 18 years old and older that 65, pregnant women, segmental or nonactive vitiligo, patients treated for vitiligo in past 3 month, patients on topical steroid medications, topical tacrolimus or elidel, patients receiving ultraviolet therapy including narrow band UVB, PUVA or tanning beds.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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American Skin Association

OTHER

Sponsor Role collaborator

Mimi Cho, MD

INDIV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mimi Cho, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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0310M52823

Identifier Type: -

Identifier Source: org_study_id