WrinkleNCT04185909

Renuvion Dermal System for Dermal Resurfacing

A study testing Renuvion Dermal System in people with Wrinkle and Rhytides, run by Apyx Medical at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 30 years and olderHealthy volunteers can take part
Conditions the study is for: Wrinkle, Rhytides
What is being tested?: Renuvion Dermal System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 55 participants
Where: 4 sitesUnited States
Study dates: 30 Dec 2019to 13 May 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

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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.

Who cannot join

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.

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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.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Contemporary Plastic Surgery
Jacksonville, Florida, 32216
Aesthetic Revolution Las Vegas
Las Vegas, Nevada, 89148
Holcomb-Kreithen Plastic Surgery and MedSpa, PLLC
Sarasota, Florida, 34237
Michael Lin, MD
Sherman Oaks, California, 91403

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Wrinkle, Rhytides
Being tested: Renuvion Dermal System

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Renuvion Dermal SystemDevice
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.

Study groups in NCT04185909
Study group	Role	What they receive
All Subjects	Experimental	Subjects will be treated with the Renuvion Dermal System. Receives: Device: Renuvion Dermal System

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 90-day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Dec 201913 May 2021

First posted4 Dec 2019
Study start30 Dec 2019
Primary completion23 Mar 2021
Study completion13 May 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for WrinkleStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04185909
Sponsor's protocol ID: VP-1909
Status last verified: Jun 2022
First submitted: 3 Dec 2019
Last updated: 22 Jun 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

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.
PubMed 35170772

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multicenter, Single Arm Clinical Study Evaluating the Use of the Renuvion Dermal System for Dermal Resurfacing
ClinicalTrials.gov ID: NCT04185909
Acronym / sponsor ID: VP-1909
Conditions: Wrinkle, Rhytides
Study type: Interventional
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: Apyx MedicalIndustry (pharma, biotech, devices)
Study start: 30 Dec 2019 (actual)
Primary completion: 23 Mar 2021 (actual)
Study completion: 13 May 2021 (actual)
First posted: 4 Dec 2019 (actual)
Results: Posted 3 Jun 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
All Subjects	Experimental	Device: Renuvion Dermal SystemSubjects will be treated with the Renuvion Dermal System.

Who may qualify

Ages: 30 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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.

Key exclusion criteria (24 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Renuvion Dermal SystemThe 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.	Device	All Subjects

Primary outcome

Independent Photo Reviewer Fitzpatrick Wrinkle and Elastosis Scale (FWS)
Time frame: 90-day
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.

Results and safety

Results posted to the registry on 3 Jun 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Full-face Renuvion Dermal System Treatment	55	54

Primary outcome: Independent Photo Reviewer Fitzpatrick Wrinkle and Elastosis Scale (FWS)

Time frame: 90-day. Count of participants. Unit: Participants

Measure	Full-face Renuvion Dermal System Treatment n = 55
Value	55

Full-face Renuvion Dermal System Treatment: p <.0001, Fisher Exact

Adverse events

Time frame: Through 6 month follow-up visit for all enrolled subjects.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Full-face Renuvion Dermal System Treatment	1 of 55 (1.8%)	55 of 55 (100%)	0 of 55

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35170772Holcomb 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Edward Zimmerman, MD principal investigator

Aesthetic Revolution Las Vegas

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Renuvion Dermal System in people with Wrinkle and Rhytides, run by Apyx Medical at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Independent Photo Reviewer Fitzpatrick Wrinkle and Elastosis Scale (FWS) (time frame: 90-day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04185909, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2022.