Renuvion Dermal System for Dermal Resurfacing

Wrinkle Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04185909
• Other study ID #: VP-1909
• Status: Completed
• Phase: N/A
• Start date: December 30, 2019
• Est. completion date: May 13, 2021

Study information

• Verified date: June 2022
• Source: Apyx Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: May 13, 2021
• Est. primary completion date: March 23, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Rhytides
• Wrinkle

Intervention

Device:
• Renuvion Dermal System
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.

Locations

Country	Name	City	State
United States	Contemporary Plastic Surgery	Jacksonville	Florida
United States	Aesthetic Revolution Las Vegas	Las Vegas	Nevada
United States	Holcomb-Kreithen Plastic Surgery and MedSpa, PLLC	Sarasota	Florida
United States	Michael Lin, MD	Sherman Oaks	California

Sponsors (1)

Lead Sponsor	Collaborator
Apyx Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Investigator Fitzpatrick Wrinkle and Elastosis Scale	Magnitude of improvement measured by the mean change in FWS from baseline, 90-day, 180-day visit as determined by Investigators. Scale ranges from 1 (no wrinkles) to 9 (most wrinkles).	Baseline, 90-day Change, 180-day Change
Other	Subject Global Aesthetic Improvement Scale	Subject rated GAIS: Very much improved, much improved, improved, no change, worse, much worse, very much worse	90-day
Other	Investigator Global Aesthetic Improvement Scale	Investigator rated GAIS: Very much improved, much improved, improved, no change, worse, much worse, very much worse	90-day
Other	Patient Satisfaction Questionnaire	5 questions pertaining to satisfaction with results, would you recommend to a friend, would you have the procedure done again, any changes noticed, and any improvement in quality of life.	90-day
Other	Pain and Discomfort	Evaluation of the change in pain and discomfort after treatment (baseline, within 60 minutes following the procedure) as reported by the subject on a visual analog scale (VAS)experienced in the period up to the 10-day follow-up visit. Any pain or discomfort will be recorded daily by each participant in a diary using an 11-point Visual Analogue Scale (VAS) where 0 is no pain and 10 is most pain.	Baseline to Day 10
Other	Percentage of Subjects With Achievement of Re-Epithelialization	Achievement of re-epithelialization by facial zone and across all facial zones as reported by the investigator.	10-day, 30-day, 90-day
Other	Comfortable in Public	Mean duration until study subject feels comfortable going in public after treatment as reported by the study subject. Willing to go out in public by the 10-day visit.	10-day
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.	90-day