Renuvion Dermal System for Dermal Resurfacing

NCT04185909 | Completed Results FDA Device

• 1 other identifier: VP-1909
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 4

Brief Summary

This is a multi-center, single arm, evaluator-blind prospective study of up to 55 study subjects who are seeking a procedure to reduce the appearance of wrinkles and rhytides.

Conditions

Wrinkle; Rhytides

Outcome Measures

Primary Outcomes (1)

• Independent Photo Reviewer Fitzpatrick Wrinkle and Elastosis Scale (FWS)

  The FWS is a clinically validated assessment tool used to assess skin wrinkle severity and elastosis on a scale from 1 through 9, where the lower the value, the better the outcome. Three Independent Photographic Reviewers were blinded to the study subject's visit (Day 90 follow-up visit) and performed photographic assessments of each subject's wrinkle depth in the treated zones.

  90-day

Other Outcomes (8)

• Independent Photographic Reviewer Masked Assessment

  90-day

• Investigator Fitzpatrick Wrinkle and Elastosis Scale

  Baseline, 90-day Change, 180-day Change

• Subject Global Aesthetic Improvement Scale

  90-day

Study Arms (1)

All Subjects

EXPERIMENTAL

Subjects will be treated with the Renuvion Dermal System.

Device: Renuvion Dermal System

Interventions

Renuvion Dermal System DEVICE

The Renuvion® Dermal System consists of an electrosurgical generator unit, a handpiece with detachable standoffs, and a supply of helium gas. Radio Frequency (RF) energy is delivered to the handpiece by the electrosurgical generator unit and used to energize an electrode. When helium gas is passed over the energized electrode, a helium plasma is generated which allows for conduction of the RF energy from the electrode to the subject in the form of a precise helium plasma beam.

All Subjects

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects ≥30 years of age.
• Subject is seeking improvement of facial appearance by reducing facial wrinkles and rhytides.
• Subject with a facial wrinkle score rating of at least 4 on the FWS.
• Subject with a Fitzpatrick Skin Scale score ≤III.
• Subjects who are willing and able to take protocol allowed medications prescribed at investigator discretion which may include Keflex or Z-pack as an antibiotic, Acyclovir or Valtrex as an antiviral, Diflucan as an antifungal, Ativan or Valium for anxiety during treatment, Norco or Ultram for pain control during or post-procedure, Gabapentin, Tylenol with Codeine or NSAIDS for post-procedure pain control, and/or Antihistamines for itching during healing.
• Subjects who are willing to have polycarbonate eye shields placed for study treatment.
• Subject is willing and able to provide written informed consent.
• Subject is willing and able to comply with protocol requirements, including obtaining study-required images/photos and assessments, post-care instructions, and returning for follow-up visits.
• Subject is willing to maintain baseline skin care regimen during study participation with the exception when protocol specified ointments, moisturizers, and cleansers are required during healing stage (through approximately the 30-day follow-up). Sunblock is required throughout the study starting on approximately day 10.
• Subject is willing to release rights to study Sponsor for the use of the photos, including in potential publication.
• Subject is willing to abstain from other facial cosmetic procedures through the 6-month follow-up visit; examples include, but are not limited to, laser or chemical re-surfacing, dermabrasion, neuromodulator and/or filler injections, aesthetic facial surgery, etc.

You may not qualify if:

• Subject with a Fitzpatrick Skin Scale score ≥IV.
• Subject is pregnant or lactating.
• Active HSV-1 or diabetes mellitus.
• Active cut, wound, or infection on the skin of the face.
• Subject has used, within 30 days prior to screening or plans to use during study participation, Accutane, Retinol, or any medication that can cause dermal hypersensitivity.
• Subject has used, within 10 days prior to study treatment, aspirin or NSAIDs.
• Subject has a history of autoimmune disease (excluding Hashimoto's thyroiditis).
• Subject with a known bleeding disorder or who is on blood thinning medication that may be at risk for bleeding.
• Subject has a known adverse reaction to lidocaine and/or epinephrine.
• Subjects with active skin disease of the facial area or known connective tissue disease.
• Subjects with known susceptibility to keloid formation or hypertrophic scarring.
• Subjects with present cancerous or pre-cancerous lesions in the area to be treated.
• Subject who, for any reason, suspects that they will not be able to complete the prescribed follow-up assessment(s).
• Subject has had concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety and effectiveness of the study treatment method.
• Subject is not willing to release rights to study Sponsor for the use of the photos, including in potential publication.

Sponsors & Collaborators

• Apyx Medical: lead

Study Sites (4)

Michael Lin, MD

Sherman Oaks, California, 91403, United States

Location

Contemporary Plastic Surgery

Jacksonville, Florida, 32216, United States

Location

Holcomb-Kreithen Plastic Surgery and MedSpa, PLLC

Sarasota, Florida, 34237, United States

Location

Aesthetic Revolution Las Vegas

Las Vegas, Nevada, 89148, United States

Location

Related Publications (1)

• Holcomb JD, Doolabh V, Lin M, Zimmerman E. High energy, double pass helium plasma dermal resurfacing: A prospective, multicenter, single-arm clinical study. Lasers Surg Med. 2022 Jul;54(5):648-662. doi: 10.1002/lsm.23524. Epub 2022 Feb 16.

  PMID: 35170772 DERIVED

Limitations and Caveats

Limitations of this study include the lack of an ideal internal control as is typically the case in facial skin resurfacing studies and in single-arm studies, inability to precisely control energy density across study sites and between subjects, inability to ensure uniformity of aftercare measures employed by subjects as well as limited post-treatment follow-up of just 6 months.

Results Point of Contact

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

kari.larson@apyxmedical.com

8012440058

Study Officials

• Edward Zimmerman, MD

  Aesthetic Revolution Las Vegas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 4, 2019
• Study Start: December 30, 2019
• Primary Completion: March 23, 2021
• Study Completion: May 13, 2021
• Last Updated: June 22, 2022
• Results First Posted: June 3, 2022

Record last verified: 2022-06

Locations

US (4)