Histological Study of the Effects of a 2910 nm Fiber Laser Technology

The goal of this interventional clinical study is to conduct a comprehensive evaluation of the 2910 nm fiber laser focusing on its diverse energy settings. 2 subjects will be recruited for this 2 part histology study. The main This study will provide valuable insights into the device's capabilities and expand knowledge of its clinical utility. The first part of this study is intended to optimize treatment parameters based on observed effects at the molecular level. The second part will investigate the state of tissue at different timepoints following treatment.

Part 1 Pre-Clinical Study Procedure:

• 1 healthy adult (male or female)
• 18-75 years of age, who are scheduled to undergo an abdominoplasty (where abdominal skin will be excised) will be recruited.
• Informed consent will be obtained by a delegated member of the study staff prior to the day of surgery.
• On the day of the scheduled procedure, the laser device will be applied to the skin that will be removed as part of the surgery. The treatment will be completed after induction and prior to prepping for the surgical procedure.

Part 2 Clinical Study Procedure:

• 1 healthy adult (male or female)
• 18-75 years of age, who are scheduled to undergo an abdominoplasty (where abdominal skin will be excised) will be recruited.
• Informed consent will be obtained by a delegated member of the study staff prior to the day of surgery.
• The study team will utilize the specific setting based off the results of Part 1.
• Subject will be asked to return to the site on days -30, -3, -2, -1 before their procedure.
• At each visit, subjects will receive a single pulse treatment in areas that will be marked by the study team.
• On the day of their procedure, a member of the study team will administer 1 final pulse immediately post-surgery and all 5 timepoints will be harvested for analysis.

Study Overview

• Status: Enrolling by invitation
• Conditions: Skin Laxity
• Intervention / Treatment: Device: 2910 nm Fiber Laser Treatment; Pre-Clinical Histology Evaluation; Device: 2910 nm Fiber Laser Treatment; Part 2 Histology Evaluation

• Study Type: Interventional
• Enrollment (Estimated): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • UT Soutwestern Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Healthy male and female adults between 18-75 years of age.
• Subjects who can read, understand, and sign the Informed Consent Form.
• Subjects willing and able to comply with all study requirements.
• Fitzpatrick skin types I-IV.
• Subjects who have pre-scheduled a body or facial contouring procedure.

Exclusion Criteria:

• Subjects with active localized or systemic infections
• Immunocompromised subjects
• Subjects with coagulation disorder
• History of radiation therapy to treatment area
• Subject with a history of lidocaine or ester-based local anesthetics
• Pacemaker or internal defibrillator
• Superficial or metal implants in the area
• Current or history of skin cancer, as well as any other type of cancer, or pre-malignant moles.
• Severe concurrent conditions, such as cardiac disorders
• Pregnancy and nursing
• Impaired immune system due to immunosuppressive diseases such as AIDS and HIV, or use of immunosuppressive medications.
• Diseases which may be stimulated by light at the wavelengths used, such as history of Systemic Lupus Erythematosus, Porphyria, and Epilepsy.
• Patients with a history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regime.
• Any active condition in the treatment area, such as sores, psoriasis eczema, and rash.
• History of skin disorders, keloids, abnormal wound healing, as well as very dry and fragile skin.
• History of bleeding coagulopathies or use of anticoagulants.
• Use of medication and herbs known to induce photosensitivity to light exposure at the wavelengths used, such as Isotretinoin (Accutane) within the last 6 months, tetracyclines, or St. John's Wort within the last two weeks.
• Any surgical procedure in the treatment area within the last 3 months or before complete healing.
• Tattoo or permanent makeup in the treatment area.
• Excessively tanned skin from sun, tanning beds or tanning creams within last the two weeks.
• As per the practitioner's discretion, refrain from treating any condition which might make it unsafe for the patient

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1 Pre-Clinical Procedure; 1 healthy adult (male or female); 18-75 years of age, who are scheduled to undergo an abdominoplasty (where abdominal skin will be excised) will be recruited.; Informed consent will be obtained by a delegated member of the study staff prior to the day of surgery.; On the day of the scheduled procedure, the laser device will be applied to the skin that will be removed as part of the surgery. The treatment will be completed after induction and prior to prepping for the surgical procedure.	Device: 2910 nm Fiber Laser Treatment; Pre-Clinical Histology Evaluation; Treatment with 2910 nm fiber laser focusing on its diverse energy settings and histological evaluation post abdominoplasty.
Experimental: Part 2 Clinical Study Procedure; 1 healthy adult (male or female); 18-75 years of age, who are scheduled to undergo an abdominoplasty (where abdominal skin will be excised) will be recruited.; Informed consent will be obtained by a delegated member of the study staff prior to the day of surgery.; The study team will utilize the specific setting based off the results of Part 1.; Subject will be asked to return to the site on days -30, -3, -2, -1 before their procedure.; At each visit, subjects will receive a single pulse treatment in areas that will be marked by the study team.; On the day of their procedure, a member of the study team will administer 1 final pulse immediately post-surgery and all 5 timepoints will be harvested for analysis.	Device: 2910 nm Fiber Laser Treatment; Part 2 Histology Evaluation; Healing Progression: Treatment with 2910 nm fiber laser focusing on its diverse energy settings and histological evaluation post abdominoplasty.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TUNEL Staining	Terminal deoxynucleotidyl transferase-mediated dUTP nick end labeling (TUNEL) is a robust technique for detecting apoptosis or cell death. Fluorescence intensity of the TUNEL positive cells in the treatment groups compare to control (untreated) will be measured. The data is given as fold change or percentage.	Up to 30 days
Mason's Trichrome	The structural analysis using Trichrome will be observational to demonstrate any deviation from the normal skin structure (descriptive tool).	Up to 30 days

Collaborators and Investigators

• Sponsor: FA Corporation
• Collaborators: University of Texas Southwestern Medical Center
• Investigators: Study Director: Shlomo Assa, President FACorp, FA Corporation; Principal Investigator: Jeffrey Kenkel, MD, UT Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2024
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: January 30, 2024
• First Submitted That Met QC Criteria: March 12, 2024
• First Posted (Actual): March 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Histology; 2910 nm Fiber Laser; Ablative Fractional Laser
• Additional Relevant MeSH Terms: Skin Diseases; Genetic Diseases, Inborn; Connective Tissue Diseases; Skin Diseases, Genetic; Cutis Laxa
• Other Study ID Numbers: UC 20-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We are unsure of the current publication plan for this clinical study data. Due to IP and confidentiality we would like to request this filing remain private.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes