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Renuvion Dermal System for Dermal Resurfacing | Clinical Trials | Clareo Health

COMPLETEDNA

Renuvion Dermal System for Dermal Resurfacing

A Prospective, Multicenter, Single Arm Clinical Study Evaluating the Use of the Renuvion Dermal System for Dermal Resurfacing

NCT04185909•Apyx Medical

View on ClinicalTrials.gov

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.

Detailed Description

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. All study subjects will be treated with the Renuvion Dermal System. The study population will consist of males and females, 30 years of age or older, requesting a procedure for the purpose of improving facial appearance by reducing facial wrinkles and rhytides. Those subjects who meet eligibility criteria and agree to provide written informed consent will be invited to participate.

Eligibility

Age

30 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Male or female subjects ≥30 years of age.
•2. Subject is seeking improvement of facial appearance by reducing facial wrinkles and rhytides.
•3. Subject with a facial wrinkle score rating of at least 4 on the FWS.
•4. Subject with a Fitzpatrick Skin Scale score ≤III.
•5. 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.
•6. Subjects who are willing to have polycarbonate eye shields placed for study treatment.
•7. Subject is willing and able to provide written informed consent.
•8. 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.
•9. 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.
•10. Subject is willing to release rights to study Sponsor for the use of the photos, including in potential publication.
+1 more criteria

Exclusion Criteria

•1. Subject with a Fitzpatrick Skin Scale score ≥IV.
•2. Subject is pregnant or lactating.
•3. Active HSV-1 or diabetes mellitus.
•4. Active cut, wound, or infection on the skin of the face.
•5. 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.
•6. Subject has used, within 10 days prior to study treatment, aspirin or NSAIDs.
•7. Subject has a history of autoimmune disease (excluding Hashimoto's thyroiditis).
•8. Subject with a known bleeding disorder or who is on blood thinning medication that may be at risk for bleeding.
•9. Subject has a known adverse reaction to lidocaine and/or epinephrine.
•10. Subjects with active skin disease of the facial area or known connective tissue disease.
+14 more criteria

Locations (4)

Michael Lin, MD

Sherman Oaks, California, United States

Contemporary Plastic Surgery

Jacksonville, Florida, United States

Holcomb-Kreithen Plastic Surgery and MedSpa, PLLC

Sarasota, Florida, United States

Aesthetic Revolution Las Vegas

Las Vegas, Nevada, United States

Key Dates

Start Date

December 30, 2019

Primary Completion Date

March 23, 2021

Completion Date

May 13, 2021

Last Updated

June 22, 2022

Enrollment

ACTUAL participants

Conditions

WrinkleRhytides

Interventions

Renuvion Dermal System

DEVICE

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WrinkleLax Skin+1 more

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 22, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Renuvion Dermal System for Dermal Resurfacing

Inclusion Criteria

Exclusion Criteria

A Prospective Controlled Study to Evaluate the Safety and Effectiveness of Thermage® FLX Radiofrequency Treatment

Evaluation of Facial HA Dermal Fillers in Real-Life Conditions

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