Skin LaxityNCT06317766
Histological Study of the Effects of a 2910 nm Fiber Laser Technology
A study testing 2910 nm Fiber Laser Treatment; Pre-Clinical Histology Evaluation and 2910 nm Fiber Laser Treatment; Part 2 Histology Evaluation in people with Skin Laxity, run by FA Corporation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Skin Laxity
- What is being tested?
- 2910 nm Fiber Laser Treatment; Pre-Clinical Histology Evaluation and 2910 nm Fiber Laser Treatment; Part 2 Histology Evaluation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Feb 2024to May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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:
Read more
- 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
- Being tested
- 2910 nm Fiber Laser Treatment; Pre-Clinical Histology Evaluation, 2910 nm Fiber Laser Treatment; Part 2 Histology Evaluation
- Keywords
- Histology, 2910 nm Fiber Laser, Ablative Fractional Laser
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2910 nm Fiber Laser Treatment; Pre-Clinical Histology EvaluationDevice
Treatment with 2910 nm fiber laser focusing on its diverse energy settings and histological evaluation post abdominoplasty.
2910 nm Fiber Laser Treatment; Part 2 Histology EvaluationDevice
Healing Progression: Treatment with 2910 nm fiber laser focusing on its diverse energy settings and histological evaluation post abdominoplasty.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: 2910 nm Fiber Laser Treatment; Part 2 Histology Evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start5 Feb 2024
- Primary completionApr 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin LaxityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FA Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Texas Southwestern Medical Center
- Responsible party
- Sponsor
- Investigators
- Shlomo Assa, President FACorp, Study director, FA CorporationJeffrey Kenkel, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06317766
- Sponsor's protocol ID
- UC 20-2023
- Status last verified
- Mar 2024
- First submitted
- 30 Jan 2024
- Last updated
- 19 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histological Study of the Effects of a 2910 nm Fiber Laser Technology
- ClinicalTrials.gov ID
- NCT06317766
- Acronym / sponsor ID
- UC 20-2023
- Conditions
- Skin Laxity
- Keywords
- Histology, 2910 nm Fiber Laser, Ablative Fractional Laser
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- FA CorporationIndustry (pharma, biotech, devices)
- Collaborators
- University of Texas Southwestern Medical Center
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 19 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 Pre-Clinical Procedure | Experimental | Device: 2910 nm Fiber Laser Treatment; Pre-Clinical Histology Evaluation* 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 | Experimental | Device: 2910 nm Fiber Laser Treatment; Part 2 Histology Evaluation* 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2910 nm Fiber Laser Treatment; Pre-Clinical Histology EvaluationTreatment with 2910 nm fiber laser focusing on its diverse energy settings and histological evaluation post abdominoplasty. | Device | Part 1 Pre-Clinical Procedure |
| 2910 nm Fiber Laser Treatment; Part 2 Histology EvaluationHealing Progression: Treatment with 2910 nm fiber laser focusing on its diverse energy settings and histological evaluation post abdominoplasty. | Device | Part 2 Clinical Study Procedure |
Primary outcome
TUNEL Staining
Time frame: Up to 30 days
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.
Mason's Trichrome
Time frame: Up to 30 days
The structural analysis using Trichrome will be observational to demonstrate any deviation from the normal skin structure (descriptive tool).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shlomo Assa, President FACorp study director
FA Corporation
Jeffrey Kenkel, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2910 nm Fiber Laser Treatment; Pre-Clinical Histology Evaluation and 2910 nm Fiber Laser Treatment; Part 2 Histology Evaluation in people with Skin Laxity, run by FA Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TUNEL Staining (time frame: Up to 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2024.