Clinical trial NCT04146467: Renuvion APR Device to Improve the Appearance of Lax Tissue in the Neck and Submental Region
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lax Skin
Keywords: Submental, Neck
Lead sponsor: Apyx Medical
Sponsor class: INDUSTRY
First posted: 2019-10-31
Enrollment: 82
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Male or female subjects 35-65 years of age (inclusive).
2. Healthy as determined by the investigator examining the subject.
3. Seeking improvement of the appearance of lax tissue in the neck and submental region.
4. Females of childbearing potential who are sexually active must be willing to use an approved method of birth control during study participation.
5. Willing and able to comply with protocol requirements, including obtaining study-required images/photos and assessments, and returning for follow-up visits.
6. Willing to release rights for the use of study photos, including in potential publication.
7. 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.
8. 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.
9. 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.
10. Willing to abstain from the use of marijuana for 2 weeks prior to and for the duration of participation in the study.
11. Able to read, understand, sign and date the informed consent document (English only).

Exclusion Criteria:

1. Pregnant or lactating.
2. Pregnancy within 12 months prior to screening.
3. 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).
4. Allergy to tumescent anesthetic (lidocaine/epinephrine).
5. Excessive subcutaneous fat in the treatment area (as determined by the treating investigator).
6. Active systemic or local skin disease that may alter wound healing.
7. Significant or uncontrolled medical condition that, in the opinion of the investigator, participation in the study may compromise the patient's health.
8. Severe solar elastosis.
9. History of autoimmune disease (excluding Hashimoto's thyroiditis).
10. Known hypersensitivity or adverse reaction to anesthetics.
11. Known susceptibility to keloid formation or hypertrophic scarring.
12. Cancerous or pre-cancerous lesions in the area to be treated.
13. History or current diagnosis of cancer of any type (excluding skin cancer).
14. History of uncontrolled cardiovascular disease (i.e. myocardial infarction, hypertension, hypercholesterolemia, peripheral vascular disease, other).
15. History, or current bleeding disorders (i.e. hemophilia or von Willebrand disease), or anticipated treatment with prescription anticoagulants.
16. Possesses a surgically implanted electronic device (i.e. pacemaker).
17. History of AIDs/HIV.
18. Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years.
19. Chronic hypoxia or dependence on supplemental oxygen.
20. Participation in any other investigational study within 30 days prior to consent.
21. 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.
22. History of or current injury to the head and neck or any area of the body being treated as a part of this study.
23. Presence of more than mild platysmal banding as per the Geister, et al Validated Assessment Scale for Platysmal Bands.
24. Subject requiring removal of adipose tissue prior index procedure.
25. A family member of the investigator or sponsor; an employee of the investigator or sponsor.
26. Subject who, in the opinion of the investigator, is not an appropriate candidate for the study.

Primary outcomes:
measure: Day 180 Number of Participants With Improvement Measured By Independent Photographic Review
timeFrame: 180-Day
measure: Subject Reported Pain - None to Moderate
timeFrame: Day 7
Secondary outcomes:
Other outcomes:
measure: Day 90 Number of Participants With Improvement Measured By Independent Photographic Review
timeFrame: 90-Day
measure: Subject Modified Global Aesthetic Improvement Scale (GAIS)
timeFrame: 90-Day
measure: Subject Modified Global Aesthetic Improvement Scale (GAIS)
timeFrame: 180-Day
measure: Investigator Modified Global Aesthetics Improvement Scale (GAIS)
timeFrame: 90-Day
measure: Investigator Modified Global Aesthetic Improvement Scale (GAIS)
timeFrame: 180-Day
measure: Day 180 Patient Satisfaction Questionnaire (PSQ) of Procedure
timeFrame: 180-Day
measure: Quantitative Improvement in Overall Lift of the Neck and Submental Area
timeFrame: 180-Day
measure: Quantitative Improvement in Submental Volume
timeFrame: 180-Day
measure: Average Pain at Day 7 Reported by Subject
timeFrame: 7-Day
measure: Median Pain Reported by Subject at Day 7
timeFrame: 7-Day
measure: Average Pain Reported by Subject at Day 30
timeFrame: 30-Day
measure: Median Pain Reported by Subject at Day 30
timeFrame: 30-Day
Locations:
city: San Diego
country: United States
facility: Faces+ Plastic Surgery
state: California
city: Washington
country: United States
facility: West End Plastic Surgery
state: District of Columbia
city: Montclair
country: United States
facility: New Jersey Clinical Research Center
state: New Jersey
city: New York
country: United States
facility: Luxurgery
state: New York
city: Huntersville
country: United States
facility: H/K/B Cosmetic Surgery
state: North Carolina
city: Youngstown
country: United States
facility: Facial Plastic & Aesthetic Laser Center
state: Ohio
Study officials:
affiliation: West End Plastic Surgery
name: Paul G Ruff IV, MD
role: PRINCIPAL_INVESTIGATOR
References: