Skin Laxity Clinical Trial
Official title:
Histological Evaluation of Human Skin Biopsies to Assess the Effects of Renuvion APR Treatment as an Adjunct Procedure in Facelift Surgery
Verified date | June 2024 |
Source | Apyx Medical |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this prospective, single-arm clinical study is to gather quantifiable data on Renuvion's impact on skin elasticity and hydration, indicators of skin quality and estimate the biological skin age using DNA methylation in males and females between 18 and 75 years of age who plan to receive a lower facelift surgery. The main purpose is to quantify the effect of the Renuvion device on skin elasticity (collagen density, elastin, fibrillin-1), hydration (aquaporin-3, acidic glycosaminoglycans, HA), and DNA methylation to estimate the biological age of the skin. Participants will receive a lower facelift surgery per the Investigator's standard clinical practice and treatment with the Renuvion APR System.
Status | Active, not recruiting |
Enrollment | 10 |
Est. completion date | December 31, 2024 |
Est. primary completion date | November 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Male or female subjects, ages 18 - 75 years old. - ASA Physical Status Classification System Class I and Class II subjects. - Planning to undergo a lower facelift procedure, with or without a neck lift, at the investigator's site. - Understands and accepts the obligation not to undergo any other procedures or treatments in the areas to be treated during study participation. - Absence of physical conditions unacceptable to the investigator. - Females of childbearing potential who are sexually active must be willing to use an approved method of birth control during study participation. - Willing and able to comply with protocol requirements, including study-required images/photos, assessments/measurements, and returning for follow-up visits. - Willing to release rights for the use of study photos, including in publication. - Able to read, understand, sign, and date the informed consent. - Able to communicate with the site via video and/or photographs, in the event of a virtual follow-up visit. Exclusion Criteria: - Subjects presenting with ASA Physical Status Classification System Classes III or higher. - Pregnant, lactating, or plans to become pregnant during study participation. - Known hypersensitivity or allergy to tumescent anesthetic (lidocaine/ epinephrine). - Known hypersensitivity or allergy to ibuprofen or other NSAIDS. - Active systemic or local skin disease that may alter wound healing. - Significant or uncontrolled medical condition that in the opinion of the investigator participation in the study may compromise the patient's health. - History of autoimmune disease (excluding Hashimoto's thyroiditis). - Known susceptibility to keloid formation or hypertrophic scarring. - Cancerous or pre-cancerous lesions in the area to be treated. - Possesses a surgically implanted electronic device (i.e. pacemaker). - Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years. - Participation in any other investigational study within 30 days prior to consent and throughout study participation. - Subject who, in the opinion of the investigator, is not an appropriate candidate for the study. - Subject who has had a prior facelift, neck lift, or Renuvion treatment in the face/neck area |
Country | Name | City | State |
---|---|---|---|
United States | LA Plastic Surgery and Dermatology | Bradenton | Florida |
United States | Holcomb & Kreithen Plastic Surgery and MedSpa | Sarasota | Florida |
Lead Sponsor | Collaborator |
---|---|
Apyx Medical |
United States,
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* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Analysis of Elasticity (collagen density, elastin, & fibrillin-1) | To assess Elasticity (collagen density, elastin, & fibrillin-1) evaluation will be based on the qualitative microscopic observation of the stained sections comparing baseline samples to follow-up samples. Histology and immunohistochemistry (IHC) part of the study will be assessed semi-quantitatively. Thus, there will not be units of measurement e.g., weight and height for these evaluations.
Semi-quantitative scoring for any microscopic changes (H&E staining) and enhancing collagen production (e.g., trichrome staining). Four-point Severity Scale Semi-Quantitative Grading of Changes in Histology Samples Description - Definition Normal - Tissue is considered to be normal Minimal - The amount of change present barely exceeds normal limits. Mild (Slight) - The amount of change is easily identified but limited severity. Moderate - The amount of change is prominent, but significant potential for increased severity. Severe - The degree of change is as complete as possible |
Baseline, Day 180 | |
Primary | Analysis of Hydration (aquaporin-3, acidic glycosaminoglycans (GAGs), hyaluronic acid (HA)) | To assess Hydration (aquaporin-3, GAGs, HA), evaluation will be based on the qualitative microscopic observation of the stained sections comparing baseline samples to follow-up samples. Histology and immunohistochemistry (IHC) part of the study will be assessed semi-quantitatively. Thus, there will not be units of measurement e.g., weight and height for these kinds of evaluations.
Semi-quantitative scoring for any microscopic changes (H&E staining) and enhancing collagen production (e.g., trichrome staining). Four-point Severity Scale Semi-Quantitative Grading of Changes in Histology Samples Description - Definition Normal - Tissue is considered to be normal Minimal - The amount of change present barely exceeds normal limits. Mild (Slight) - The amount of change is easily identified but limited severity. Moderate - The amount of change is prominent, but significant potential for increased severity. Severe - The degree of change is as complete as possible |
Baseline, Day 180 | |
Primary | Analysis of Adverse Events | Analysis of adverse events through the 180-day post-treatment visit. | Treatment, Day 1, 7, 14, 45, 90, 180 | |
Primary | Analyzing days of duration for Bruising, Swelling | Analysis days of duration of bruising and swelling post-treatment through the 180-day visit. | Post-Treatment, Day 1, 7, 14, 45, 90, 180 | |
Primary | Days to healed percentage | Analysis average number of days to healed profile post-procedure through the 180-day post-treatment visit through Case Report Forms through percentage healed at each follow-up. | Post-Treatment, Day 1, 7, 14, 45, 90, 180 | |
Primary | Bleeding | Analysis of bleeding during surgery measured in cubic centimeter. | During Procedure (Day 0) | |
Primary | The Principal Investigator will complete a PGAIS assessing overall aesthetic improvement in the treatment area at day 45, 90, and 180 post-treatment. | Global Aesthetic Improvement Scale Evaluation (PGAIS) rating by investigator [Very much improved, Much improved, Improved, No change, Worse, Much Worse, Very much Worse] | Day 45, 90 and180 | |
Primary | The subject will complete a SGAIS assessing overall aesthetic improvement in the treatment area at day 45, 90, and 180 post-treatment. | Subject Global Aesthetic Improvement Scale Evaluation (SGAIS) rating by subject [Very much improved, Much improved, Improved, No change, Worse, Much Worse, Very much Worse] | Day 45, 90 and180 | |
Primary | Patient Satisfaction | The subject will complete a Patient Satisfaction Questionnaire (PSQ) while referring to their image in a mirror and current post-treatment photos compared to baseline photos to rate how satisfied they are, and if they note any improvement in the treatment area. | Day 180 | |
Primary | Estimated biological age by DNA methylation. | DNA methylation (DNAm) will be used to measure the tissue samples to estimate the biological age of the skin. A highly accurate skin-specific age algorithm will analyze these modifications related to human skin health and molecular aging - quantifying the skin health/skin age of the tissue beyond the chronological age of the subject. Hallmarks of aging include genomic instability, telomere attrition, epigenetic alterations, loss of proteostasis, deregulated nutrient sensing, mitochondrial dysfunction, cellular senescence, stem cell exhaustion, and altered intercellular communication. | Baseline, Day 180 |
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