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

NCT06317766 | Enrolling By Invitation FDA Device

• 1 other identifier: UC 20-2023
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Skin Laxity

Keywords

Histology; 2910 nm Fiber Laser; Ablative Fractional Laser

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Part 1 Pre-Clinical Procedure

EXPERIMENTAL

* 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

Part 2 Clinical Study Procedure

EXPERIMENTAL

* 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

Interventions

2910 nm Fiber Laser Treatment; Pre-Clinical Histology Evaluation DEVICE

Treatment with 2910 nm fiber laser focusing on its diverse energy settings and histological evaluation post abdominoplasty.

Part 1 Pre-Clinical Procedure

2910 nm Fiber Laser Treatment; Part 2 Histology Evaluation DEVICE

Healing Progression: Treatment with 2910 nm fiber laser focusing on its diverse energy settings and histological evaluation post abdominoplasty.

Part 2 Clinical Study Procedure

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• FA Corporation: lead
• University of Texas Southwestern Medical Center: collaborator

Study Sites (1)

UT Soutwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Shlomo Assa, President FACorp

  FA Corporation

  STUDY DIRECTOR

• Jeffrey Kenkel, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: March 19, 2024
• Study Start: February 5, 2024
• Primary Completion: April 1, 2024
• Study Completion: May 1, 2024
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)