Examination Of Vitiligo Skin Samples Before and After UVB Treatment

Vitiligo Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00177034
• Other study ID #: 0310M52823
• Status: Terminated
• Phase: N/A
• First received: September 12, 2005
• Last updated: July 9, 2012
• Start date: November 2004
• Est. completion date: December 2005

Study information

• Verified date: July 2012
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Vitiligo

Intervention

Drug:
• Narrow Band UVB Treatment

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mimi Cho, MD	American Skin Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Once genes profiling in keratinocytes between lesional and nonlesional skin is accomplished, we would like to characterize these keratinocyte populations after therapy.
Secondary	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.