Clinical trial NCT04185909: Renuvion Dermal System for Dermal Resurfacing
Official title: A Prospective, Multicenter, Single Arm Clinical Study Evaluating the Use of the Renuvion Dermal System for Dermal Resurfacing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wrinkle
Rhytides
Lead sponsor: Apyx Medical
Sponsor class: INDUSTRY
First posted: 2019-12-04
Enrollment: 55
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Male or female subjects ≥30 years of age.
2. Subject is seeking improvement of facial appearance by reducing facial wrinkles and rhytides.
3. Subject with a facial wrinkle score rating of at least 4 on the FWS.
4. Subject with a Fitzpatrick Skin Scale score ≤III.
5. 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.
6. Subjects who are willing to have polycarbonate eye shields placed for study treatment.
7. Subject is willing and able to provide written informed consent.
8. 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.
9. 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.
10. Subject is willing to release rights to study Sponsor for the use of the photos, including in potential publication.
11. 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:

1. Subject with a Fitzpatrick Skin Scale score ≥IV.
2. Subject is pregnant or lactating.
3. Active HSV-1 or diabetes mellitus.
4. Active cut, wound, or infection on the skin of the face.
5. 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.
6. Subject has used, within 10 days prior to study treatment, aspirin or NSAIDs.
7. Subject has a history of autoimmune disease (excluding Hashimoto's thyroiditis).
8. Subject with a known bleeding disorder or who is on blood thinning medication that may be at risk for bleeding.
9. Subject has a known adverse reaction to lidocaine and/or epinephrine.
10. Subjects with active skin disease of the facial area or known connective tissue disease.
11. Subjects with known susceptibility to keloid formation or hypertrophic scarring.
12. Subjects with present cancerous or pre-cancerous lesions in the area to be treated.
13. Subject who, for any reason, suspects that they will not be able to complete the prescribed follow-up assessment(s).
14. 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.
15. Subject is not willing to release rights to study Sponsor for the use of the photos, including in potential publication.
16. Subject is enrolled in another investigational (drug or device) clinical trial that can interfere with this study's assessments.
17. Subject has undergone a facelift procedure within 12 months prior to the screening visit.
18. Subject has received IPL, microneedling, or chemical peels within 3 months prior to the screening visit.
19. Subject has received microneedling with RF or any facial treatment with an energy-based device within 6 months prior to the screening visit.
20. Subject has received facial injections with BOTOX® or other toxins within 6 months prior to the screening visit.
21. Subject has received hyaluronic acid or calcium hydroxylapatite fillers within 4 months prior to the screening visit.
22. Subject who is a family member or employee of the investigator or sponsor.
23. Participation in any other investigational study within 30 days prior to consent.
24. Subject who, in the opinion of the investigator, is not an appropriate candidate for the study.

Primary outcomes:
measure: Independent Photo Reviewer Fitzpatrick Wrinkle and Elastosis Scale (FWS)
timeFrame: 90-day
Secondary outcomes:
Other outcomes:
measure: Independent Photographic Reviewer Masked Assessment
timeFrame: 90-day
measure: Investigator Fitzpatrick Wrinkle and Elastosis Scale
timeFrame: Baseline, 90-day Change, 180-day Change
measure: Subject Global Aesthetic Improvement Scale
timeFrame: 90-day
measure: Investigator Global Aesthetic Improvement Scale
timeFrame: 90-day
measure: Patient Satisfaction Questionnaire
timeFrame: 90-day
measure: Pain and Discomfort
timeFrame: Baseline to Day 10
measure: Percentage of Subjects With Achievement of Re-Epithelialization
timeFrame: 10-day, 30-day, 90-day
measure: Comfortable in Public
timeFrame: 10-day
Locations:
city: Sherman Oaks
country: United States
facility: Michael Lin, MD
state: California
city: Jacksonville
country: United States
facility: Contemporary Plastic Surgery
state: Florida
city: Sarasota
country: United States
facility: Holcomb-Kreithen Plastic Surgery and MedSpa, PLLC
state: Florida
city: Las Vegas
country: United States
facility: Aesthetic Revolution Las Vegas
state: Nevada
Study officials:
affiliation: Aesthetic Revolution Las Vegas
name: Edward Zimmerman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.