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Examination Of Vitiligo Skin Samples Before and After UVB Treatment

Primary Purpose

Vitiligo

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Narrow Band UVB Treatment
Sponsored by
Mimi Cho, MD
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Vitiligo focused on measuring Keratinocyte

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of Minnesota

Outcomes

Primary Outcome Measures

Once genes profiling in keratinocytes between lesional and nonlesional skin is accomplished, we would like to characterize these keratinocyte populations after therapy.

Secondary Outcome Measures

Keratinocytes have not been studied by gene expression analysis in this setting. The results from microarray analysis will be useful to see if the difference between lesional and nonlesional gene expression is reversed by therapy.

Full Information

First Posted
September 12, 2005
Last Updated
July 9, 2012
Sponsor
Mimi Cho, MD
Collaborators
American Skin Association
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1. Study Identification

Unique Protocol Identification Number
NCT00177034
Brief Title
Examination Of Vitiligo Skin Samples Before and After UVB Treatment
Official Title
Characterization of Keratinocyte Populations From Normal, Perilesional and Lesional Skin in Vitiligo Patients by Laser Capture Microdissection and Gene Array Analysis Before and After Narrow Band UVB Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Terminated
Study Start Date
November 2004 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mimi Cho, MD
Collaborators
American Skin Association

4. Oversight

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Narrow Band UVB Treatment
Primary Outcome Measure Information:
Title
Once genes profiling in keratinocytes between lesional and nonlesional skin is accomplished, we would like to characterize these keratinocyte populations after therapy.
Secondary Outcome Measure Information:
Title
Keratinocytes have not been studied by gene expression analysis in this setting. The results from microarray analysis will be useful to see if the difference between lesional and nonlesional gene expression is reversed by therapy.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mimi Cho, MD, PhD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

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Examination Of Vitiligo Skin Samples Before and After UVB Treatment

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