Renuvion APR Device to Improve the Appearance of Lax Tissue in the Neck and Submental Region

NCT04146467 | Completed Results FDA Device

• 1 other identifier: VP-1902
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 6

Brief Summary

This is a prospective, multi-center, multi-phase, evaluator-blinded study of subjects undergoing a procedure with the Renuvion APR Device to improve the appearance of lax tissue in the neck and submental region.

Conditions

Lax Skin

Keywords

Submental, Neck

Outcome Measures

Primary Outcomes (2)

• Day 180 Number of Participants With Improvement Measured By Independent Photographic Review

  Improvement in the appearance of lax tissue in the neck and submental region at 6 months as determined by qualitative 2D photography assessment by blinded Independent Photographic Reviewers. Three experienced, blinded photographic reviewers performed a qualitative analysis/review of the pre-treatment and post-treatment sets of images of each subject in a blinded and randomized order. Each blinded reviewer chose which image was the post-treatment image. Success was correct post-treatment image selection by at least 2 of the 3 reviewers. The percentage of subjects with a correct post-treatment image selection was calculated.

  180-Day

• Subject Reported Pain - None to Moderate

  The primary safety endpoint is the level of pain and discomfort after treatment as reported by the subject on an 11-point Numeric Rating Scale (NRS) through the 7-day follow-up visit where 0 is no pain and 10 is the most pain. Pain scores are classified as scores of 0 being no pain, 1 - 5 is minor pain, 6 - 7 is moderate pain, and 8 - 10 is severe pain. The primary safety objective is to demonstrate that the proportion of subjects with none-to- moderate pain exceeds the performance goal (PG). The performance goal is 55%.

  Day 7

Other Outcomes (12)

• Day 90 Number of Participants With Improvement Measured By Independent Photographic Review

  90-Day

• Subject Modified Global Aesthetic Improvement Scale (GAIS)

  90-Day

• Subject Modified Global Aesthetic Improvement Scale (GAIS)

  180-Day

Study Arms (2)

Study Phase I

EXPERIMENTAL

Subjects will be treated with the Renuvion APR device in the neck and submental region.

Device: Renuvion APR Device

Study Phase II

EXPERIMENTAL

Subjects will be treated with the Renuvion APR device in the neck and submental region.

Device: Renuvion APR Device

Interventions

Renuvion APR Device DEVICE

The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.

Study Phase I; Study Phase II

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects 35-65 years of age (inclusive).
• Healthy as determined by the investigator examining the subject.
• Seeking improvement of the appearance of lax tissue in the neck and submental region.
• 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 obtaining study-required images/photos and assessments, and returning for follow-up visits.
• Willing to release rights for the use of study photos, including in potential publication.
• Understands and accepts the obligation not to have significant weight loss or weight gain (≥8 pounds) post the treatment, and for the duration of participation in the study.
• Willing to abstain from the use of blood thinners (including, but not limited to, Coumadin, NSAIDS, Ibuprofen, vitamin K, other) for 2 weeks (14 days) prior to the procedure.
• Willing to abstain from smoking, vaping, or the use of e-cigarettes for 1 year prior to and for the entire duration of participation in the study.
• Willing to abstain from the use of marijuana for 2 weeks prior to and for the duration of participation in the study.
• Able to read, understand, sign and date the informed consent document (English only).

You may not qualify if:

• Pregnant or lactating.
• Pregnancy within 12 months prior to screening.
• Use within 24 hours preceding surgery of ibuprofen, acetaminophen, any other analgesics, anti-inflammatory products, or any products including herbals and supplements that could interfere with the clinical assessments of this study (other than drugs used for anesthesia).
• Allergy to tumescent anesthetic (lidocaine/epinephrine).
• Excessive subcutaneous fat in the treatment area (as determined by the treating investigator).
• 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.
• Severe solar elastosis.
• History of autoimmune disease (excluding Hashimoto's thyroiditis).
• Known hypersensitivity or adverse reaction to anesthetics.
• Known susceptibility to keloid formation or hypertrophic scarring.
• Cancerous or pre-cancerous lesions in the area to be treated.
• History or current diagnosis of cancer of any type (excluding skin cancer).
• History of uncontrolled cardiovascular disease (i.e. myocardial infarction, hypertension, hypercholesterolemia, peripheral vascular disease, other).
• History, or current bleeding disorders (i.e. hemophilia or von Willebrand disease), or anticipated treatment with prescription anticoagulants.

Sponsors & Collaborators

• Apyx Medical: lead

Study Sites (6)

Faces+ Plastic Surgery

San Diego, California, 92121, United States

Location

West End Plastic Surgery

Washington D.C., District of Columbia, 20037, United States

Location

New Jersey Clinical Research Center

Montclair, New Jersey, 07042, United States

Location

Luxurgery

New York, New York, 10021, United States

Location

H/K/B Cosmetic Surgery

Huntersville, North Carolina, 28078, United States

Location

Facial Plastic & Aesthetic Laser Center

Youngstown, Ohio, 44512, 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

Limitations and Caveats

Limitations of this study was the pandemic that occurred in the middle of the study and caused study visits to be more challenging for all subjects enrolled.

Results Point of Contact

• Title: Kari Larson, MBA, Sr. Director, Clinical Affairs
• Organization: Apyx Medical

kari.larson@apyxmedical.com

8012440058

Study Officials

• Paul G Ruff IV, MD

  West End Plastic Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: October 29, 2019
• First Posted: October 31, 2019
• Study Start: November 26, 2019
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: July 20, 2022
• Results First Posted: July 8, 2022

Record last verified: 2022-07

Locations

US (6)