Gene Expression Changes In Young and Geriatric Skin

Sponsor

Wright State University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03932162

Collaborator

(none)

Enrollment

Location

Arms

45.8

Anticipated Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
UVB Phototherapy Burn Insulin-like Growth Factor 1 Aging	Drug: Insulin-Like Growth Factor 1 Other: No Insulin-Lie Growth Factor 1	Early Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Gene Expression Changes in Young and Geriatric Skin

Actual Study Start Date :

Sep 6, 2019

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Jul 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Young Adult One small area of skin will undergo treatment with a small amount of UVB.	Other: No Insulin-Lie Growth Factor 1 No Insulin-Like Growth Factor 1 will be given.
Active Comparator: 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.	Drug: Insulin-Like Growth Factor 1 Growth factor protein

Arm

Intervention/Treatment

Placebo Comparator: Young Adult

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

Other: No Insulin-Lie Growth Factor 1

No Insulin-Like Growth Factor 1 will be given.

Active Comparator: 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.

Drug: Insulin-Like Growth Factor 1

Growth factor protein

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Wright State Physicians	Fairborn	Ohio	United States	45324

Sponsors and Collaborators

Wright State University

Investigators

Principal Investigator: Jeffrey B Travers, MD, PhD, Wright State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wright State University

ClinicalTrials.gov Identifier:

NCT03932162

Other Study ID Numbers:

06694

First Posted:

Apr 30, 2019

Last Update Posted:

Mar 28, 2022

Last Verified:

Mar 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Insulin

Insulin, Globin Zinc

Mitogens

Study Results

No Results Posted as of Mar 28, 2022