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Examination Of Vitiligo Skin Samples Before and After UVB Treatment

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ClinicalTrials.gov Identifier: NCT00177034
Recruitment Status : Terminated
First Posted : September 15, 2005
Last Update Posted : July 10, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Vitiligo Drug: Narrow Band UVB Treatment

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : November 2004
Primary Completion Date : December 2005
Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. 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 :
  1. 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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00177034


Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Mimi Cho, MD
American Skin Association
Investigators
Principal Investigator: Mimi Cho, MD, PhD University of Minnesota - Clinical and Translational Science Institute
More Information

Responsible Party: Mimi Cho, MD
ClinicalTrials.gov Identifier: NCT00177034     History of Changes
Other Study ID Numbers: 0310M52823
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: July 10, 2012
Last Verified: July 2012

Keywords provided by University of Minnesota - Clinical and Translational Science Institute ( Mimi Cho, MD ):
Keratinocyte

Additional relevant MeSH terms:
Vitiligo
Hypopigmentation
Pigmentation Disorders
Skin Diseases