NCT00397436

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Feb 2007

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2006

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2007

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

May 17, 2016

Status Verified

May 1, 2016

Enrollment Period

4.8 years

First QC Date

November 7, 2006

Last Update Submit

May 13, 2016

Conditions

Proteomics

Outcome Measures

Primary Outcomes (1)

  • Ability to quantify protein changes at cytoplasmic and membrane protein levels of epidermal cells in normal vs. irradiated skin

    1 year

Secondary Outcomes (1)

  • Obtain a profile of membrane integrated and cytoplasmic proteins of epidermal cell populations which will facilitate our understanding of biological responses to UV irradiation.

    1 year

Study Arms (1)

1

EXPERIMENTAL

Comparing irradiated skin to non irradiated skin.

Procedure: UV Irradiation

Interventions

UV IrradiationPROCEDURE

UV irradiation

Also known as: UV irradiation.
1

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy Males age 18-30
  • Caucasian
  • No neurological disease

You may not qualify if:

  • Use of any medication that affects skin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Study Officials

  • George Wilcox, PhD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2006

First Posted

November 9, 2006

Study Start

February 1, 2007

Primary Completion

November 1, 2011

Study Completion

December 1, 2015

Last Updated

May 17, 2016

Record last verified: 2016-05

Locations

US(1)