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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03932162
Other study ID # 06694
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date September 6, 2019
Est. completion date December 2025

Study information

Verified date January 2024
Source Wright State University
Contact Manager, Clinical Research Operations
Phone 937-245-7500
Email pturesearch@wrightstatephysicians.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 24
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Insulin-Like Growth Factor 1
Growth factor protein
Other:
No Insulin-Lie Growth Factor 1
No Insulin-Like Growth Factor 1 will be given.

Locations

Country Name City State
United States Wright State Physicians Fairborn Ohio

Sponsors (1)

Lead Sponsor Collaborator
Wright State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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