Gene Expression Changes In Young and Geriatric Skin

NCT ID: NCT03932162

Last Updated: 2025-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-06

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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UVB Phototherapy Burn Insulin-like Growth Factor 1 Aging

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Young Adult

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

Group Type PLACEBO_COMPARATOR

No Insulin-Lie Growth Factor 1

Intervention Type OTHER

No Insulin-Like Growth Factor 1 will be given.

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.

Group Type ACTIVE_COMPARATOR

Insulin-Like Growth Factor 1

Intervention Type DRUG

Growth factor protein

Interventions

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Insulin-Like Growth Factor 1

Growth factor protein

Intervention Type DRUG

No Insulin-Lie Growth Factor 1

No Insulin-Like Growth Factor 1 will be given.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wright State University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeffrey B Travers, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Wright State University

Locations

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Wright State Physicians

Fairborn, Ohio, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Manager, Clinical Research Operations

Role: CONTACT

937-245-7500

Regulatory Specialist

Role: CONTACT

937-245-7500

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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06694

Identifier Type: -

Identifier Source: org_study_id

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