Renuvion Dermal System for Dermal Resurfacing

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Wrinkle, Rhytides

Intervention / Treatment
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* Device: Renuvion Dermal System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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. Subject is enrolled in another investigational (drug or device) clinical trial that can interfere with this study's assessments. Subject has undergone a facelift procedure within 12 months prior to the screening visit. Subject has received IPL, microneedling, or chemical peels within 3 months prior to the screening visit. Subject has received microneedling with RF or any facial treatment with an energy-based device within 6 months prior to the screening visit. Subject has received facial injections with BOTOX® or other toxins within 6 months prior to the screening visit. Subject has received hyaluronic acid or calcium hydroxylapatite fillers within 4 months prior to the screening visit. Subject who is a family member or employee of the investigator or sponsor. Participation in any other investigational study within 30 days prior to consent. Subject who, in the opinion of the investigator, is not an appropriate candidate for the study.

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All Subjects<br>Subjects will be treated with the Renuvion Dermal System. | Device: Renuvion Dermal System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |