Pilot Study of Protein Profiling of the Human Epidermal Cells After Ultraviolet Irradiation - Full Text View

Sponsored by:	University of Minnesota
Information provided by:	University of Minnesota
ClinicalTrials.gov Identifier:	NCT00397436

Purpose

The main focus of this pilot study is to construct a fairly complete protein profile of the epidermis. This will allow us to study how the epidermis responds to external stressors such as ultra-violet. We hypothesize that by using the cutting edge technology, proteomics, we will be able to construct a fairly complete profile of different epidermal cells (keratinocytes, epidermal nerve fibers (ENFs), melanocytes, Langerhans cell,...etc) of normal and ultraviolet (UV) irradiated skin.

Condition	Intervention	Phase
Proteomics	Procedure: UV Irradiation	Phase 0

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	Pilot Study of Protein Profiling of the Human Epidermal Cells After Ultraviolet Irradiation

Further study details as provided by University of Minnesota:

Primary Outcome Measures:

Ability to quantify protein changes at cytoplasmic and membrane protein levels of epidermal cells in normal vs. irradiated skin [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Obtain a profile of membrane integrated and cytoplasmic proteins of epidermal cell populations which will facilitate our understanding of biological responses to UV irradiation. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	February 2007
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Comparing irradiated skin to non irradiated skin.	Procedure: UV Irradiation UV irradiation

Detailed Description:

We will investigate the changes of the epidermal cell proteome after UV irradiation to the forearms of healthy young male volunteers. Knowledge of specific molecular markers may provide knowledge of basic biological systems and possibly targeted therapy of inflammation.

By using combined proteomic methodologies we will be able to quantify protein changes at cytoplasmic and membrane protein levels of epidermal cells in normal vs. irradiated skins.

This study may allow us to obtain fairly comprehensive profile of membrane integrated and cytoplasmic proteins of epidermal cell populations which will facilitate our understand of biological responses to UV irradiation.

Eligibility

Ages Eligible for Study:	18 Years to 30 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy Males age 18-30
Caucasian
No neurological disease

Exclusion Criteria:

Use of any medication that affects skin

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00397436

Contacts

Contact: George Wilcox, PhD

612-625-1474

george@umn.edu

Locations

United States, Minnesota
University of Minnesota	Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: George Wilcox 612-625-1474 george@umn.edu
Principal Investigator: George Wilcox

Sponsors and Collaborators

University of Minnesota

Investigators

Principal Investigator:

George Wilcox, PhD

University of Minnesota

More Information

Responsible Party:	University of Minnesota ( George Wilcox )
Study ID Numbers:	0506M70827
Study First Received:	November 7, 2006
Last Updated:	September 12, 2008
ClinicalTrials.gov Identifier:	NCT00397436
Health Authority:	United States: Institutional Review Board

ClinicalTrials.gov processed this record on January 14, 2009