Renuvion Dermal System for Dermal Resurfacing | NCT04185909

NCT04185909

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Label	Type	Description	Intervention Names
All Subjects	Experimental	Subjects will be treated with the Renuvion Dermal System.	Device: Renuvion Dermal System

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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

Other Outcomes

Measure	Description	Time Frame
Independent Photographic Reviewer Masked Assessment	At least 2 out of 3 blinded Independent Photographic Reviewers (IPRs) correctly identify the 90-day image of a subject from the pair of baseline and 90-day images.	90-day
Investigator Fitzpatrick Wrinkle and Elastosis Scale

Eligibility Module

Eligibility Criteria

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.

Name	Affiliation	Role
Edward Zimmerman, MD	Aesthetic Revolution Las Vegas	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Michael Lin, MD		Sherman Oaks	California	91403	United States
Contemporary Plastic Surgery

PubMed Identifier	Type	Citation	Retractions
35170772	Derived	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.

Arm/Group Information

ID	Title	Description
FG000	Full-face Renuvion Dermal System Treatment	Perioral, Forehead, Nose, and Cheek zones were treated with two (2) passes of the plasma beam at 40% power and 4 liters/minute helium flow utilizing the appropriate standoff with one pass done horizontally and the other pass done perpendicular. The Periorbital zone was treated with one (1) or two (2) passes, based on the investigator's discretion, 20% power and 4 liters/minute helium flow utilizing the appropriate standoff (spacer) with up to 2 passes done horizontally or only in one direction. The Jawline/Mandibular Border was treated with one (1) or two (2) passes, based on the investigator's discretion, at 20% - 40% power and 4 liters/minute helium flow using the appropriate standoff and a treatment pattern in a variable motion to achieve blending. For areas that were treated with a 2nd pass, the eschar was wiped away entirely prior to start of the 2nd pass.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Full-face Renuvion Dermal System Treatment	Perioral, Forehead, Nose, and Cheek zones were treated with two (2) passes of the plasma beam at 40% power and 4 liters/minute helium flow utilizing the appropriate standoff with one pass done horizontally and the other pass done perpendicular. The Periorbital zone was treated with one (1) or two (2) passes, based on the investigator's discretion, 20% power and 4 liters/minute helium flow utilizing the appropriate standoff (spacer) with up to 2 passes done horizontally or only in one direction. The Jawline/Mandibular Border was treated with one (1) or two (2) passes, based on the investigator's discretion, at 20% - 40% power and 4 liters/minute helium flow using the appropriate standoff and a treatment pattern in a variable motion to achieve blending. For areas that were treated with a 2nd pass, the eschar was wiped away entirely prior to start of the 2nd pass.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Customized			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

Posted

Count of Participants

Participants

90-day

ID	Title	Description
OG000	Full-face Renuvion Dermal System Treatment	Perioral, Forehead, Nose, and Cheek zones were treated with two (2) passes of the plasma beam at 40% power and 4 liters/minute helium flow utilizing the appropriate standoff with one pass done horizontally and the other pass done perpendicular. The Periorbital zone was treated with one (1) or two (2) passes, based on the investigator's discretion, 20% power and 4 liters/minute helium flow utilizing the appropriate standoff (spacer) with up to 2 passes done horizontally or only in one direction. The Jawline/Mandibular Border was treated with one (1) or two (2) passes, based on the investigator's discretion, at 20% - 40% power and 4 liters/minute helium flow using the appropriate standoff and a treatment pattern in a variable motion to achieve blending. For areas that were treated with a 2nd pass, the eschar was wiped away entirely prior to start of the 2nd pass.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Full-face Renuvion Dermal System Treatment	Perioral, Forehead, Nose, and Cheek zones were treated with two (2) passes of the plasma beam at 40% power and 4 liters/minute helium flow utilizing the appropriate standoff with one pass done horizontally and the other pass done perpendicular. The Periorbital zone was treated with one (1) or two (2) passes, based on the investigator's discretion, 20% power and 4 liters/minute helium flow utilizing the appropriate standoff (spacer) with up to 2 passes done horizontally or only in one direction. The Jawline/Mandibular Border was treated with one (1) or two (2) passes, based on the investigator's discretion, at 20% - 40% power and 4 liters/minute helium flow using the appropriate standoff and a treatment pattern in a variable motion to achieve blending. For areas that were treated with a 2nd pass, the eschar was wiped away entirely prior to start of the 2nd pass.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Bowel Obstruction	Gastrointestinal disorders		Non-systematic Assessment	The subject was admitted to the hospital for bowel obstruction. After Investigator review, this event was identified to be secondary to prior bowel cancer that was not reported by subject at baseline. This is not related to study device or procedure.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Erythema/skin inflammation/ focal skin congestion (Expected Treatment Effect)	Skin and subcutaneous tissue disorders		Systematic Assessment

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	May 11, 2020	Mar 15, 2022	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Dec 10, 2019	Mar 15, 2022	SAP_001.pdf