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Clinical Trials/NCT03932162
NCT03932162
Recruiting
Early Phase 1

Gene Expression Changes in Young and Geriatric Skin

Wright State University1 site in 1 country24 target enrollmentSeptember 6, 2019

Overview

Phase
Early Phase 1
Intervention
Insulin-Like Growth Factor 1
Conditions
UVB Phototherapy Burn
Sponsor
Wright State University
Enrollment
24
Locations
1
Primary Endpoint
Change in expression genes involved in protecting skin cells from UVB damage in younger skin and geriatric skin injected with IGF-1 from baseline
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

This study does not involve any particular diagnosis. The goal of this research study is to explore the effects of artificial sunlight (ultraviolet B radiation; UVB) on the skin of young adults versus geriatric adults. Sunlight exerts many effects on the body. There is evidence that in response to ultraviolet B radiation (UVB), which are the burning rays of sunlight, young adult skin responds differently than geriatric skin. In fact, researchers feel that this difference in how the skin reacts to UVB is why skin cancers are found in older skin. Researchers believe that a major difference between young adult and geriatric skin is that young skin has a lot of a protein called insulin-like growth factor-1 (IGF-1), whereas geriatric skin has very little. The current study will test how young adult versus geriatric skin responds to UVB, and if geriatric skin treated with an injection of small amount of IGF-1 drug will then act like young skin.

Registry
clinicaltrials.gov
Start Date
September 6, 2019
End Date
December 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Male/Female
  • White skin (Fitzpatrick types I and II)
  • Age 21-30 or 65 and older
  • Able to comprehend procedures/risks

Exclusion Criteria

  • Known photosensitivity
  • Currently on photosensitizing medications
  • Diabetes Mellitus
  • History of abnormal scarring
  • History of skin infections
  • Known allergy to lidocaine local anesthetic
  • Pregnancy or nursing
  • Other serious health issues

Arms & Interventions

Geriatric Adult

Four small areas will undergo injection of a small amount of IGF-1 drug and two will undergo injections with saline. Then the injected areas will be treated with a small amount of UVB.

Intervention: Insulin-Like Growth Factor 1

Young Adult

One small area of skin will undergo treatment with a small amount of UVB.

Intervention: No Insulin-Lie Growth Factor 1

Outcomes

Primary Outcomes

Change in expression genes involved in protecting skin cells from UVB damage in younger skin and geriatric skin injected with IGF-1 from baseline

Time Frame: 2 Days

Expression genes involved in protecting skin cells from UVB damage, including p21, xeroderma pigmentosum (XPC), and polymerase eta, will be higher following UVB exposure in younger skin and geriatric skin injected with IGF-1 than in geriatric skin injected with saline as a control.

Study Sites (1)

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