Lax SkinNCT04146467
Renuvion APR Device to Improve the Appearance of Lax Tissue in the Neck and Submental Region
A study testing Renuvion APR Device in people with Lax Skin, run by Apyx Medical at 6 sites in United States.
Trial summary
This is a prospective, multi-center, multi-phase, evaluator-blinded study of subjects undergoing a procedure with the Renuvion APR Device to improve the appearance of lax tissue in the neck and submental region. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Lax Skin
- What is being tested?
- Renuvion APR Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 6 sitesUnited States
- Study dates
- 26 Nov 2019to 28 Feb 2022
- 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 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female subjects 35-65 years of age (inclusive).
- Healthy as determined by the investigator examining the subject.
- Seeking improvement of the appearance of lax tissue in the neck and submental region.
- Females of childbearing potential who are sexually active must be willing to use an approved method of birth control during study participation.
- Willing and able to comply with protocol requirements, including obtaining study-required images/photos and assessments, and returning for follow-up visits.
- Willing to release rights for the use of study photos, including in potential publication.
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- Understands and accepts the obligation not to have significant weight loss or weight gain (≥8 pounds) post the treatment, and for the duration of participation in the study.
- Willing to abstain from the use of blood thinners (including, but not limited to, Coumadin, NSAIDS, Ibuprofen, vitamin K, other) for 2 weeks (14 days) prior to the procedure.
- Willing to abstain from smoking, vaping, or the use of e-cigarettes for 1 year prior to and for the entire duration of participation in the study.
- Willing to abstain from the use of marijuana for 2 weeks prior to and for the duration of participation in the study.
- Able to read, understand, sign and date the informed consent document (English only).
Who cannot join
- Pregnant or lactating.
- Pregnancy within 12 months prior to screening.
- Use within 24 hours preceding surgery of ibuprofen, acetaminophen, any other analgesics, anti-inflammatory products, or any products including herbals and supplements that could interfere with the clinical assessments of this study (other than drugs used for anesthesia).
- Allergy to tumescent anesthetic (lidocaine/epinephrine).
- Excessive subcutaneous fat in the treatment area (as determined by the treating investigator).
- Active systemic or local skin disease that may alter wound healing.
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- Significant or uncontrolled medical condition that, in the opinion of the investigator, participation in the study may compromise the patient's health.
- Severe solar elastosis.
- History of autoimmune disease (excluding Hashimoto's thyroiditis).
- Known hypersensitivity or adverse reaction to anesthetics.
- Known susceptibility to keloid formation or hypertrophic scarring.
- Cancerous or pre-cancerous lesions in the area to be treated.
- History or current diagnosis of cancer of any type (excluding skin cancer).
- History of uncontrolled cardiovascular disease (i.e. myocardial infarction, hypertension, hypercholesterolemia, peripheral vascular disease, other).
- History, or current bleeding disorders (i.e. hemophilia or von Willebrand disease), or anticipated treatment with prescription anticoagulants.
- Possesses a surgically implanted electronic device (i.e. pacemaker).
- History of AIDs/HIV.
- Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years.
- Chronic hypoxia or dependence on supplemental oxygen.
- Participation in any other investigational study within 30 days prior to consent.
- Any surgical or transdermal neck/submental aesthetic procedures or plans to undergo any other aesthetic procedure during study participation. Such procedures include, but are not limited to, submentoplasty, liposuction, ultrasound, cryolipolysis, radiofrequency, and laser.
- History of or current injury to the head and neck or any area of the body being treated as a part of this study.
- Presence of more than mild platysmal banding as per the Geister, et al Validated Assessment Scale for Platysmal Bands.
- Subject requiring removal of adipose tissue prior index procedure.
- A family member of the investigator or sponsor; an employee of the investigator or sponsor.
- Subject who, in the opinion of the investigator, is not an appropriate candidate for the study.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
H/K/B Cosmetic Surgery
Huntersville, North Carolina, 28078
New Jersey Clinical Research Center
Montclair, New Jersey, 07042
Luxurgery
New York, New York, 10021
Faces+ Plastic Surgery
San Diego, California, 92121
West End Plastic Surgery
Washington D.C., District of Columbia, 20037
Facial Plastic & Aesthetic Laser Center
Youngstown, Ohio, 44512
About this study
Official title: A Prospective, Multi-Center, Evaluator-Blinded Study Evaluating the Safety and Effectiveness of the Renuvion APR Device to Improve the Appearance of Lax Tissue in the Neck and Submental Region
This is a prospective, multi-center, multi-phase, evaluator-blinded study of subjects undergoing a procedure with the Renuvion APR Device to improve the appearance of lax tissue in the neck and submental region.
Read the detailed description
This is a prospective, multi-center, multi-phase, evaluator-blinded study of subjects undergoing a procedure to improve the appearance of lax tissue in the neck and submental region. All study subjects will be treated with the Renuvion APR Device.
Phase I (n=17) of this study will be conducted primarily to provide safety data, however, effectiveness data will also be collected at the above stated timepoints through 6 months post-procedure.
Phase II (n=65) of this study is the expansion of the study to a pivotal study.
- Conditions
- Lax Skin
- Being tested
- Renuvion APR Device
- Keywords
- Submental, Neck
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renuvion APR DeviceDevice
The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.
| Study group | Role | What they receive |
|---|---|---|
| Study Phase I | Experimental | Subjects will be treated with the Renuvion APR device in the neck and submental region. Receives: Device: Renuvion APR Device |
| Study Phase II | Experimental | Subjects will be treated with the Renuvion APR device in the neck and submental region. Receives: Device: Renuvion APR Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Day 180 Number of Participants With Improvement Measured By Independent Photographic Review
Improvement in the appearance of lax tissue in the neck and submental region at 6 months as determined by qualitative 2D photography assessment by blinded Independent Photographic Reviewers. Three experienced, blinded photographic reviewers performed a qualitative analysis/review of the pre-treatment and post-treatment sets of images of each subject in a blinded and randomized order. Each blinded reviewer chose which image was the post-treatment image. Success was correct post-treatment image selection by at least 2 of the 3 reviewers. The percentage of subjects with a correct post-treatment image selection was calculated.
Measured: 180-Day
Subject Reported Pain - None to Moderate
The primary safety endpoint is the level of pain and discomfort after treatment as reported by the subject on an 11-point Numeric Rating Scale (NRS) through the 7-day follow-up visit where 0 is no pain and 10 is the most pain. Pain scores are classified as scores of 0 being no pain, 1 - 5 is minor pain, 6 - 7 is moderate pain, and 8 - 10 is severe pain.
The primary safety objective is to demonstrate that the proportion of subjects with none-to- moderate pain exceeds the performance goal (PG). The performance goal is 55%.
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start26 Nov 2019
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
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.
- Other trials for Lax SkinStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apyx Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul G Ruff IV, MD, Principal investigator, West End Plastic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04146467
- Sponsor's protocol ID
- VP-1902
- Status last verified
- Jul 2022
- First submitted
- 29 Oct 2019
- Last updated
- 20 Jul 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center, Evaluator-Blinded Study Evaluating the Safety and Effectiveness of the Renuvion APR Device to Improve the Appearance of Lax Tissue in the Neck and Submental Region
- ClinicalTrials.gov ID
- NCT04146467
- Acronym / sponsor ID
- VP-1902
- Conditions
- Lax Skin
- Keywords
- Submental, Neck
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Apyx MedicalIndustry (pharma, biotech, devices)
- Study start
- 26 Nov 2019 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 31 Oct 2019 (actual)
- Results
- Posted 8 Jul 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 prospective, multi-center, multi-phase, evaluator-blinded study of subjects undergoing a procedure with the Renuvion APR Device to improve the appearance of lax tissue in the neck and submental region.
Detailed description
This is a prospective, multi-center, multi-phase, evaluator-blinded study of subjects undergoing a procedure to improve the appearance of lax tissue in the neck and submental region. All study subjects will be treated with the Renuvion APR Device.
Phase I (n=17) of this study will be conducted primarily to provide safety data, however, effectiveness data will also be collected at the above stated timepoints through 6 months post-procedure.
Phase II (n=65) of this study is the expansion of the study to a pivotal study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Phase I | Experimental | Device: Renuvion APR DeviceSubjects will be treated with the Renuvion APR device in the neck and submental region. |
| Study Phase II | Experimental | Device: Renuvion APR DeviceSubjects will be treated with the Renuvion APR device in the neck and submental region. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female subjects 35-65 years of age (inclusive).
- Healthy as determined by the investigator examining the subject.
- Seeking improvement of the appearance of lax tissue in the neck and submental region.
- Females of childbearing potential who are sexually active must be willing to use an approved method of birth control during study participation.
- Willing and able to comply with protocol requirements, including obtaining study-required images/photos and assessments, and returning for follow-up visits.
Key exclusion criteria (26 listed)
- Pregnant or lactating.
- Pregnancy within 12 months prior to screening.
- Use within 24 hours preceding surgery of ibuprofen, acetaminophen, any other analgesics, anti-inflammatory products, or any products including herbals and supplements that could interfere with the clinical assessments of this study (other than drugs used for anesthesia).
- Allergy to tumescent anesthetic (lidocaine/epinephrine).
- Excessive subcutaneous fat in the treatment area (as determined by the treating investigator).
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 APR DeviceThe Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma. | Device | Study Phase I, Study Phase II |
Primary outcome
Day 180 Number of Participants With Improvement Measured By Independent Photographic Review
Time frame: 180-Day
Improvement in the appearance of lax tissue in the neck and submental region at 6 months as determined by qualitative 2D photography assessment by blinded Independent Photographic Reviewers. Three experienced, blinded photographic reviewers performed a qualitative analysis/review of the pre-treatment and post-treatment sets of images of each subject in a blinded and randomized order. Each blinded reviewer chose which image was the post-treatment image. Success was correct post-treatment image selection by at least 2 of the 3 reviewers. The percentage of subjects with a correct post-treatment image selection was calculated.
Subject Reported Pain - None to Moderate
Time frame: Day 7
The primary safety endpoint is the level of pain and discomfort after treatment as reported by the subject on an 11-point Numeric Rating Scale (NRS) through the 7-day follow-up visit where 0 is no pain and 10 is the most pain. Pain scores are classified as scores of 0 being no pain, 1 - 5 is minor pain, 6 - 7 is moderate pain, and 8 - 10 is severe pain. The primary safety objective is to demonstrate that the proportion of subjects with none-to- moderate pain exceeds the performance goal (PG). The performance goal is 55%.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Paul G Ruff IV, MD principal investigator
West End Plastic Surgery
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Renuvion APR Device in people with Lax Skin, run by Apyx Medical at 6 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 26 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 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 8 Jul 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?
Day 180 Number of Participants With Improvement Measured By Independent Photographic Review (time frame: 180-Day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2022.