Gene Expression Changes In Young and Geriatric Skin

Gene Expression Changes in Young and Geriatric Skin

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.

Study Overview

• Status: Recruiting
• Conditions: Aging; UVB Phototherapy Burn; Insulin-like Growth Factor 1
• Intervention / Treatment: Other: No Insulin-Lie Growth Factor 1; Drug: Insulin-Like Growth Factor 1

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Manager, Clinical Research Operations; Phone Number: 937-245-7500; Email: pturesearch@wrightstatephysicians.org
• Study Contact Backup: Name: Regulatory Specialist; Phone Number: 937-245-7500; Email: pturesearch@wrightstatephysicians.org

Study Locations

• United States
  • Ohio
    • Fairborn, Ohio, United States, 45324
      • Recruiting
      • Wright State Physicians

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in expression genes involved in protecting skin cells from UVB damage in younger skin and geriatric skin injected with IGF-1 from baseline	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.	2 Days

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2019
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: April 26, 2019
• First Submitted That Met QC Criteria: April 26, 2019
• First Posted (Actual): April 30, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 5, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hypoglycemic Agents; Mitosis Modulators; Insulin; Insulin, Globin Zinc; Mitogens
• Other Study ID Numbers: 06694

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes