The Use of J-Plasma® for Dermal Resurfacing

Facial Wrinkles Clinical Trial

Official title:

A Prospective, Multicenter, Single Arm Clinical Study Evaluating the Use of J-Plasma® for Dermal Resurfacing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03286283
• Other study ID #: VP-1558
• Status: Completed
• Phase: N/A
• Start date: January 22, 2018
• Est. completion date: November 16, 2018

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: November 16, 2018
• Est. primary completion date: August 20, 2018
• Accepts healthy volunteers: No
• 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 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.

Related Conditions & MeSH terms

• Facial Wrinkles
• Rhytides

Intervention

Device:
• J-Plasma
Dermal resurfacing procedure with J-Plasma.

Locations

Country	Name	City	State
United States	Atlanta Dermatology, Vein & Research Center	Alpharetta	Georgia
United States	Miami Plastic Surgery	Miami	Florida
United States	Institute for Integrated Aesthetics	Sarasota	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Apyx Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Fitzpatrick Wrinkle and Elastosis Scale (FWS) = 1-score improvement and = 75% agreement with at least an "improved" rating by the subject on the modified Global Aesthetic Improvement Scale (GAIS) at 3 months compared to baseline. FWS Scale: Min=1, Max=9, where 1 is best and 9 is worst. The larger the difference between the baseline and 3 month scores, the greater the improvement. Modified GAIS Scale ratings: "Very much improved," "Much improved," "Improved," "No change," "Worse," "Much worse," and "Very much worse." An "improvement" on the modified GAIS includes "Improved," "Much improved," or "Very much improved."	Baseline to 3 months
Other	Mean Change in Fitzpatrick Wrinkle and Elastosis Scale (FWS) From Baseline to 3-month Follow-up Visit	Magnitude of improvement measured by the mean change in Fitzpatrick Wrinkle and Elastosis Scale (FWS) from baseline to 3-month visit. Scale of 1 to 9 where 1 represents the lowest severity of wrinkles and 9 represents the greatest severity of wrinkles. Negative change value represents aesthetic improvement.	Baseline to 3 months
Other	Study Subject Satisfaction at 3-month Visit	Evaluation of the subject satisfaction as reported by the subject on a visual analog scale (VAS). VAS scale ranges 0-10, 0 = best possible level of satisfaction, 10= worst possible level of satisfaction	3 Months
Other	Achievement of Re-epithelialization - 10 Days	Achievement of re-epithelialization by facial zone and across facial zones after treatment	10 Days
Other	Achievement of Re-epithelialization - 1 Month	Achievement of re-epithelialization by facial zone and across facial zones after treatment	1 Month
Other	Achievement of Re-epithelialization - 3 Months	Achievement of re-epithelialization by facial zone and across facial zones after treatment	3 Months
Other	Mean Duration for Study Subject to Feel Comfortable in Public After Treatment	Mean duration for study subject to feel comfortable in public after treatment as reported by the subject	Up to 3 months
Other	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)	Daily 10-point Visual Analog Scale (VAS) pain assessments following treatment through the 10 day follow-up visit by diary day with a change from the VAS pain score at baseline. The 10 day follow-up visit window was 9-14 days. Not all participants recorded their VAS score every day on the daily diary; daily diary was collected from each participant at their 10 day follow-up visit (visit window: 9-14 days).	Pre-procedure, post-procedure and Daily through 10 Day Follow-up Visit, approximately 9-14 days
Other	Proportion of Subjects With Correct Identification of 3-month Images	The proportion of subjects (i.e. percentage of treatment responders) with correct identification of 3-month images, in comparison to baseline, as determined by at least 2 out of 3 blinded Independent Photographic Reviewers.	Baseline to 3 months
Primary	Improvement in Fitzpatrick Wrinkle and Elastosis Scale (FWS) Score	The comparison of the proportion of subjects (i.e. percentage of treatment responders) with a = 1-score improvement on the FWS at the 3-month visit, as compared to baseline as determined by at least 2 out of 3 blinded Independent Photographic Reviewers. Min=1, Max=9, where 1 is best and 9 is worst. The larger the difference between the baseline and 3 month scores, the greater the improvement.	Baseline to 3 months
Primary	Adverse Event Rate and Duration	Adverse event rates, categorized by duration	Up to 3 months
Secondary	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.	Assessment of modified Global Aesthetic Improvement Scale (GAIS) at the 3-month visit compared to baseline as assessed by the investigator. Scale ratings: "Very much improved," "Much improved," "Improved," "No change," "Worse," "Much worse," and "Very much worse." An "improvement" on the modified GAIS includes "Improved," "Much improved," or "Very much improved."	Baseline to 3 months
Secondary	Evaluation of Pain and Discomfort	The evaluation of the pain and discomfort after treatment as reported by the subject on a 10-point visual analog scale (VAS). Mean change in VAS from baseline to 3 months. 0 = best possible level of pain and discomfort, 10= worst possible level of pain and discomfort.	Baseline to 3 months