Mechanisms for Laser-Induced Rejuvenation

NCT06489301 | Not Yet Recruiting FDA Device

• 1 other identifier: 2023-312
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Skin Cancer

Outcome Measures

Primary Outcomes (2)

• To test if the new fibroblasts that develop in response to fractionated laser resurfacing (FLR) wounding are derived from blood-derived monocytes.

  Identify cells in the skin that have been wounded by FLR at 2 weeks and 1 week previously, for cells that co-express markers for both fibroblasts and monocytes by using single cell RNA-sequencing

  2 weeks prior to skin removal and 1 week prior to skin removal

• To test if possible cells transitioning from monocytes to fibroblasts are found in the top part of the dermis (papillary dermis).

  Using tissue RNA-seq, PI will define if co-expressing cells are in the papillary dermis.

  2 weeks prior to skin removal and 1 week prior to skin removal

Secondary Outcomes (3)

• To define the number and types of cells populating the skin following fractionated laser resurfacing (FLR) wounding

  2 weeks prior to skin removal and 1 week prior to skin removal

• To define the locations of the number of cells populating in the skin following fractionated laser resurfacing (FLR) wounding

  2 weeks prior to skin removal and 1 week prior to skin removal

• To define the locations of the types of cells populating in the skin following fractionated laser resurfacing (FLR) wounding

  2 weeks prior to skin removal and 1 week prior to skin removal

Study Arms (1)

Fractionated Laser Resurfacing

EXPERIMENTAL

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.

Device: Fractionated Laser Resurfacing

Interventions

Fractionated Laser Resurfacing DEVICE

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

Fractionated Laser Resurfacing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wright State University: lead

Study Sites (1)

Wright State Physicians

Fairborn, Ohio, 45324, United States

Location

MeSH Terms

Conditions

Skin Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jeffrey Travers, MD, PhD

  Wright State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manager, Clinical Research Operations

CONTACT

937-245-7500; pturesearch@wrightstatephysicians.org

Regulatory Specialist

CONTACT

937-245-7500; pturesearch@wrightstatephysicians.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All subjects will receive fractionated laser resurfacing.

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: July 5, 2024
• Study Start: July 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 25, 2025

Record last verified: 2025-03

Locations

US (1)