Clinical trial NCT06489301: Mechanisms for Laser-Induced Rejuvenation
Official title: Mechanisms for Laser-Induced Rejuvenation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Skin Cancer
Lead sponsor: Wright State University
Sponsor class: OTHER
First posted: 2024-07-05
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All subjects will receive fractionated laser resurfacing.
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: To test if the new fibroblasts that develop in response to fractionated laser resurfacing (FLR) wounding are derived from blood-derived monocytes.
timeFrame: 2 weeks prior to skin removal and 1 week prior to skin removal
measure: To test if possible cells transitioning from monocytes to fibroblasts are found in the top part of the dermis (papillary dermis).
timeFrame: 2 weeks prior to skin removal and 1 week prior to skin removal
Secondary outcomes:
measure: To define the number and types of cells populating the skin following fractionated laser resurfacing (FLR) wounding
timeFrame: 2 weeks prior to skin removal and 1 week prior to skin removal
measure: To define the locations of the number of cells populating in the skin following fractionated laser resurfacing (FLR) wounding
timeFrame: 2 weeks prior to skin removal and 1 week prior to skin removal
measure: To define the locations of the types of cells populating in the skin following fractionated laser resurfacing (FLR) wounding
timeFrame: 2 weeks prior to skin removal and 1 week prior to skin removal
Other outcomes:
Locations:
city: Fairborn
country: United States
facility: Wright State Physicians
state: Ohio
Study officials:
affiliation: Wright State University
name: Jeffrey Travers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: