Mechanisms for Laser-Induced Rejuvenation

NCT ID: NCT06489301

Last Updated: 2025-03-25

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-31

Study Completion Date

2028-12-31

Brief Summary

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It has shown that laser wounding of geriatric skin protects it against skin cancer. The purpose of this study is to determine the origin of cells called fibroblasts which are present after treatment with Fractionated Laser Resurfacing (FLR). These cells restore a youth-like ultraviolet B (UVB) response, but where they come from is currently unknown. The study recruits subjects who are scheduled to undergo abdominoplasties to investigate the origin of those cells stimulated by laser treatment.

Detailed Description

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Conditions

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Skin Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All subjects will receive fractionated laser resurfacing.
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Fractionated Laser Resurfacing

At 14 days prior to scheduled surgery a 5x5cm square on the left abdomen within the region of skin to be excised and treated with fractionated laser resurfacing. Then at 7 days prior to scheduled surgery a 5 cm diameter circle on the right abdomen within the region of skin to be excised, at least 10 cm away from the square, is treated with fractionated laser resurfacing.

Group Type EXPERIMENTAL

Fractionated Laser Resurfacing

Intervention Type DEVICE

A rejuvenating laser that makes tiny holes in the very superficial part of the skin.

Interventions

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Fractionated Laser Resurfacing

A rejuvenating laser that makes tiny holes in the very superficial part of the skin.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adult males and females 18 and older
* Able to comprehend procedures and risks
* Planning to undergo abdominoplasty surgery
* Minimum amount of skin to be removed is 50 x 20cm

Exclusion Criteria

* Medical history of not well-controlled diabetes. This is defined as a subject who needs high doses of insulin, recent history of hospitalization for diabetes-related complications, or poor wound health as evidenced by diabetic ulcers. Subjects who have been deemed healthy enough for abdominoplasty surgery would tend to suggest that their diabetes should not be an issue. However, if the subjects have diabetic complications as outlined above, they could affect the wound healing which is the object of this protocol so they would be excluded.
* Pregnant or nursing
* History of pathologically abnormal wound healing such as keloidal scars
* Existing tattoos on the abdomen that are so extensive that they could interfere with the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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 Travers, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Wright State University

Locations

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Wright State Physicians

Fairborn, Ohio, United States

Site Status

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

Other Identifiers

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2023-312

Identifier Type: -

Identifier Source: org_study_id

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