Clinical trial NCT03286283: The Use of J-Plasma® for Dermal Resurfacing
Official title: A Prospective, Multicenter, Single Arm Clinical Study Evaluating the Use of J-Plasma® for Dermal Resurfacing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Facial Wrinkles
Rhytides
Keywords: Rhytides
Wrinkle Reduction
J-Plasma
Dermal Resurfacing
Lead sponsor: Apyx Medical
Sponsor class: INDUSTRY
First posted: 2017-09-18
Enrollment: 55
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a multi-center, single arm, evaluator-blind prospective study of 55 study subjects who are seeking a procedure to reduce the appearance of wrinkles and rhytides. Enrolled study subjects will receive one procedure with J-Plasma at enrollment. Wrinkle severity will be assessed using the Fitzpatrick Wrinkle and Elastosis Scale (FWS) at baseline and at each follow-up time point. Scores at each follow-up time point will be compared to the scores at baseline for each enrolled subject.
Primary purpose: TREATMENT

Brief summary: This study evaluates the safety and effectiveness of J-Plasma in the reduction of facial wrinkles and rhytides. It is a multi-center, single arm, evaluator-blind prospective study of 55 study subjects who are seeking a procedure to reduce the appearance of wrinkles and rhytides and will be conducted at up to 5 investigational centers in the United States. Each study subject will receive one procedure with J-Plasma at enrollment. Follow-up will occur immediately following the procedure, at 10 days, 1, 3, and 6 months after enrollment.

Detailed description: The study objective is to demonstrate the safety and efficacy of the J-Plasma system for use in dermal skin resurfacing.

This is a multi-center, single arm, evaluator-blind prospective study of 55 study subjects who are seeking a procedure to reduce the appearance of wrinkles and rhytides at up to 5 investigational centers in the United States.

Study subjects that meet study eligibility criteria and have provided informed consent will be enrolled in the study. During the procedure, the investigators will use J-Plasma on applicable facial zones to reduce wrinkles and rhytides.

Study subjects will be followed immediately following the procedure, at 10 days, 1, 3, and 6 months post-procedure for study assessments.

Study enrollment is expected to occur over 3-6 months. Imaging and study assessments will continue through 6 months post-procedure. Total study duration is expected to be approximately 9-12 months.

Primary study endpoints will be assessed at 3 months following the procedure.

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 2 on the FWS as determined by the investigator.
4. Subject with a Fitzpatrick Skin Scale score ≤III.
5. Subject is willing and able to provide written informed consent.
6. Subject is willing and able to comply with protocol requirements, including obtaining study-required images/photos and assessments, and returning for follow-up visits.
7. Subject is willing to release rights to study Sponsor for the use of the photos, including in potential publication.
8. 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 \>III.
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 the past 30 days, Accutane or any medication that can cause dermal hypersensitivity.
6. Subject has a history of autoimmune disease.
7. Subject with a bleeding disorder or who is on blood thinning medication that may be at risk for bleeding.
8. Subject has a known adverse reaction to anesthetics.
9. Subjects with active skin disease of the facial area or known connective tissue disease.
10. Subjects with known susceptibility to keloid formation or hypertrophic scarring.
11. Subjects with present cancerous or pre-cancerous lesions in the area to be treated.
12. Subject who, for any reason, suspects that they will not be able to complete the prescribed follow-up assessment(s);
13. Subject has had concurrent therapy that, in the investigator's opinion, would interfere with the evaluation of the safety and efficacy of the study treatment method.
14. Subject is not willing to release rights to study Sponsor for the use of the photos, including in potential publication.
15. Subject is enrolled in another investigational (drug or device) clinical trial that can interfere with this study's assessments.
16. Subject has undergone a facelift procedure or received facial injections within the past year.

Primary outcomes:
measure: Improvement in Fitzpatrick Wrinkle and Elastosis Scale (FWS) Score
timeFrame: Baseline to 3 months
measure: Adverse Event Rate and Duration
timeFrame: Up to 3 months
Secondary outcomes:
measure: Number of Participants With a ≥ 1-score Improvement on the Fitzpatrick Wrinkle and Elastosis Scale (FWS) and at Least an "Improved" Rating on the Modified Global Aesthetic Improvement Scale (GAIS) at the 3-month Visit.
timeFrame: Baseline to 3 months
measure: Evaluation of Pain and Discomfort
timeFrame: Baseline to 3 months
Other outcomes:
measure: Number of Participants With an Improvement on the FWS (as Scored by Independent Reviewers) and Modified GAIS Scale (as Scored by Participants) at 3 Months
timeFrame: Baseline to 3 months
measure: Mean Change in Fitzpatrick Wrinkle and Elastosis Scale (FWS) From Baseline to 3-month Follow-up Visit
timeFrame: Baseline to 3 months
measure: Study Subject Satisfaction at 3-month Visit
timeFrame: 3 Months
measure: Achievement of Re-epithelialization - 10 Days
timeFrame: 10 Days
measure: Achievement of Re-epithelialization - 1 Month
timeFrame: 1 Month
measure: Achievement of Re-epithelialization - 3 Months
timeFrame: 3 Months
measure: Mean Duration for Study Subject to Feel Comfortable in Public After Treatment
timeFrame: Up to 3 months
measure: Study Subject - Pain/Discomfort Daily 10-point Visual Analog Scale (VAS) Pre-procedure, Post-procedure, and Daily Through the 10 Day Follow-up Visit (10d FUV Visit Window: 9-14 Days)
timeFrame: Pre-procedure, post-procedure and Daily through 10 Day Follow-up Visit, approximately 9-14 days
measure: Proportion of Subjects With Correct Identification of 3-month Images
timeFrame: Baseline to 3 months
Locations:
city: Miami
country: United States
facility: Miami Plastic Surgery
state: Florida
city: Sarasota
country: United States
facility: Institute for Integrated Aesthetics
state: Florida
city: Alpharetta
country: United States
facility: Atlanta Dermatology, Vein & Research Center
state: Georgia
Study officials:
affiliation: Apyx Medical (formerly Bovie Medical Corporation)
name: Cindy Ponce, BS(ACS)
role: STUDY_DIRECTOR
References:
citation: Holcomb JD, Kelly M, Hamilton TK, DeLozier JB 3rd. A Prospective Study Evaluating the Use of Helium Plasma for Dermal Resurfacing. Lasers Surg Med. 2020 Dec;52(10):940-951. doi: 10.1002/lsm.23257. Epub 2020 Apr 29.