Mechanisms for Laser-Induced Rejuvenation
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
Study Contact
- Name: Manager, Clinical Research Operations
- Phone Number: 937-245-7500
- Email: pturesearch@wrightstatephysicians.org
Study Contact Backup
- Name: Regulatory Specialist
- Phone Number: 937-245-7500
- Email: pturesearch@wrightstatephysicians.org
Study Locations
-
-
Ohio
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Fairborn, Ohio, United States, 45324
- Recruiting
- Pharmacology Translational Unit
-
Contact:
- Pharmacology Translational Unit
- Phone Number: 937-245-7500
- Email: pturesearch@wrightstatephysicians.org
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: 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.
|
A rejuvenating laser that makes tiny holes in the very superficial part of the skin.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To test if the new fibroblasts that develop in response to fractionated laser resurfacing (FLR) wounding are derived from blood-derived monocytes.
Time Frame: 2 weeks prior to skin removal and 1 week prior to skin removal
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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).
Time Frame: 2 weeks prior to skin removal and 1 week prior to skin removal
|
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 Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
To define the number and types of cells populating the skin following fractionated laser resurfacing (FLR) wounding
Time Frame: 2 weeks prior to skin removal and 1 week prior to skin removal
|
Define the number and types of cells following FLR wounding at 2 weeks and 1 week prior to skin removal by using single-cell RNA-seq.
|
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
Time Frame: 2 weeks prior to skin removal and 1 week prior to skin removal
|
Define the locations of the number cell following FLR wounding at 2 weeks and 1 week prior to skin removal by using tissue RNA-seq.
|
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
Time Frame: 2 weeks prior to skin removal and 1 week prior to skin removal
|
Define the locations of the different cell types following FLR wounding at 2 weeks and 1 week prior to skin removal by using tissue RNA-seq.
|
2 weeks prior to skin removal and 1 week prior to skin removal
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: Jeffrey Travers, MD, PhD, Wright State University
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 2023-312
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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