Histological Evaluation of Human Skin Biopsies to Assess the Effects of Renuvion APR Treatment as an Adjunct Procedure in Facelift Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Apyx Medical
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Bleeding
研究概览
简要总结
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.
详细描述
The purpose of this 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.
This study is a prospective, single-arm clinical study to be conducted at up to three clinical sites in the US. Up to 10 subjects will be enrolled and treated if they meet the inclusion/exclusion criteria and provide written informed consent.
Enrolled subjects meeting all entrance criteria and confirmed eligible for study treatment will be asked to participate. Subjects will receive a lower facelift surgery per the Investigator's standard clinical practice and treatment with the Renuvion APR System. The mid/upper-face area will not be treated with Renuvion and the lower face/neck area will be treated with Renuvion. Treatment will consist of subdermal coagulation of soft tissue using the Renuvion APR handpiece.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Bleeding
时间窗: During Procedure (Day 0)
Analysis of bleeding during surgery measured in cubic centimeter. The reported data is for the lower face treatment area only; the control area was not evaluated for bleeding.
Patient Satisfaction
时间窗: Day 180
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. The reported data is for the lower face treatment area only; the control area was not evaluated for PSQ as it was not treated.
Analysis of Elasticity (Collagen & Elastin)
时间窗: Baseline, Day 180
To assess Elasticity (collagen \& elastin) evaluation will be based on the qualitative histology in samples at baseline and Day 180 follow-up. Two samples from each time period were analyses - control and treatment area. The H\&E, trichrome, and van Gieson-stained slides were evaluated via light microscopy for any abnormalities and extracellular matrix changes. The results of histopathological assessment were scored using the industry standard 5-point scoring system. 0=Normal, 1=Minimal, 2=Mild, 3=Moderate, 4=Severe.
Analyzing Days of Duration for Bruising, Swelling
时间窗: Post-Treatment, Day 1, 7, 14, 45, 90, 180
Analysis days of duration of overall facial bruising and swelling post-treatment through the 180-day visit. The reported data is for the lower face treatment area only; the control area was not evaluated for bruising/swelling.
Percentage of Lower Face Area Healed
时间窗: Post-Treatment, Day 1, 7, 14, 45, 90, 180
Percentage of the lower facial treatment area assessed as healed at each post-treatment time frame (Days 1, 7, 14, 45, 90 \& 180) based on investigator clinical evaluation documented in Case Report Forms. The reported data is for the lower face treatment area only; the control untreated mid/upper-face area was not evaluated for healing.
The Principal Investigator Will Complete a PGAIS Assessing Overall Aesthetic Improvement in the Treatment Area at Day 180 Post-treatment.
时间窗: Day 180
Global Aesthetic Improvement Scale Evaluation (PGAIS) rating by investigator \[Very much improved, Much improved, Improved, No change, Worse, Much Worse, Very much Worse\]. The reported data is for the lower face treatment area only; the control area was not evaluated for GAIS as it was not treated.
The Subject Will Complete a SGAIS Assessing Overall Aesthetic Improvement in the Treatment Area at Day 180 Post-treatment.
时间窗: Day 180
Subject Global Aesthetic Improvement Scale Evaluation (SGAIS) rating by subject \[Very much improved, Much improved, Improved, No change, Worse, Much Worse, Very much Worse\]. The reported data is for the lower face treatment area only; the control area was not evaluated for GAIS as it was not treated.
次要结局
未报告次要终点