Gene Expression Changes In Young and Geriatric Skin
Gene Expression Changes in Young and Geriatric Skin
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1
Started Sep 2019
Longer than P75 for early_phase_1
1 active site
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
April 26, 2019
CompletedFirst Posted
Study publicly available on registry
April 30, 2019
CompletedStudy Start
First participant enrolled
September 6, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedFebruary 6, 2025
February 1, 2025
6.2 years
April 26, 2019
February 5, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Young Adult
PLACEBO COMPARATOROne small area of skin will undergo treatment with a small amount of UVB.
Geriatric Adult
ACTIVE COMPARATORFour 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.
Interventions
Eligibility Criteria
You may qualify if:
- Male/Female
- White skin (Fitzpatrick types I and II)
- Age 21-30 or 65 and older
- Able to comprehend procedures/risks
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wright State Physicians
Fairborn, Ohio, 45324, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeffrey B Travers, MD, PhD
Wright State University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 26, 2019
First Posted
April 30, 2019
Study Start
September 6, 2019
Primary Completion
December 1, 2025
Study Completion
December 1, 2025
Last Updated
February 6, 2025
Record last verified: 2025-02