Trial Outcomes & Findings for The Use of J-Plasma® for Dermal Resurfacing (NCT NCT03286283)

NCT ID: NCT03286283

Last Updated: 2022-07-27

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 55 participants
• Primary outcome timeframe: Baseline to 3 months
• Results posted on: 2022-07-27

Participant Flow

All participants who were enrolled were assigned to a/the treatment group.

Participant milestones

Measure	J-Plasma Each study subject will receive one procedure with J-Plasma at enrollment. J-Plasma: Dermal resurfacing procedure with J-Plasma.
Overall Study STARTED	55
Overall Study COMPLETED	55
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Use of J-Plasma® for Dermal Resurfacing

Baseline characteristics by cohort

Measure	J-Plasma n=55 Participants Each study subject received one procedure with J-Plasma at enrollment. J-Plasma: Dermal resurfacing procedure with J-Plasma.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	37 Participants n=5 Participants
Age, Categorical >=65 years	18 Participants n=5 Participants
Age, Continuous	61.5 years n=5 Participants
Sex: Female, Male Female	51 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race/Ethnicity, Customized American Indian/Alaskan Native	1 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	10 Participants n=5 Participants
Race/Ethnicity, Customized White	48 Participants n=5 Participants
Region of Enrollment United States	55 participants n=5 Participants
Fitzpatrick Wrinkle and Elastosis Scale (FWS) Score Baseline FWS Score = 1	1 Participants n=5 Participants
Fitzpatrick Wrinkle and Elastosis Scale (FWS) Score Baseline FWS Score = 2	2 Participants n=5 Participants
Fitzpatrick Wrinkle and Elastosis Scale (FWS) Score Baseline FWS Score = 3	1 Participants n=5 Participants
Fitzpatrick Wrinkle and Elastosis Scale (FWS) Score Baseline FWS Score = 4	10 Participants n=5 Participants
Fitzpatrick Wrinkle and Elastosis Scale (FWS) Score Baseline FWS Score = 5	4 Participants n=5 Participants
Fitzpatrick Wrinkle and Elastosis Scale (FWS) Score Baseline FWS Score = 6	1 Participants n=5 Participants
Fitzpatrick Wrinkle and Elastosis Scale (FWS) Score Baseline FWS Score = 7	8 Participants n=5 Participants
Fitzpatrick Wrinkle and Elastosis Scale (FWS) Score Baseline FWS Score = 8	20 Participants n=5 Participants
Fitzpatrick Wrinkle and Elastosis Scale (FWS) Score Baseline FWS Score = 9	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 3 months

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.

Outcome measures

Measure	J-Plasma n=55 Participants Each study subject received one procedure with J-Plasma at enrollment. J-Plasma: Dermal resurfacing procedure with J-Plasma.
Improvement in Fitzpatrick Wrinkle and Elastosis Scale (FWS) Score	51 Participants

PRIMARY outcome

Timeframe: Up to 3 months

Adverse event rates, categorized by duration

Outcome measures

Measure	J-Plasma n=55 Participants Each study subject received one procedure with J-Plasma at enrollment. J-Plasma: Dermal resurfacing procedure with J-Plasma.
Adverse Event Rate and Duration Percentage of Serious Adverse Events	0 percentage of adverse events
Adverse Event Rate and Duration Percentage of Adverse Events Resolved in 7 Days	41.8 percentage of adverse events
Adverse Event Rate and Duration Percentage Adverse Events Resolved in 14 Days	58 percentage of adverse events

SECONDARY outcome

Timeframe: Baseline to 3 months

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."

Outcome measures

Measure	J-Plasma n=55 Participants Each study subject received one procedure with J-Plasma at enrollment. J-Plasma: Dermal resurfacing procedure with J-Plasma.
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.	53 Participants

SECONDARY outcome

Timeframe: Baseline to 3 months

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.

Outcome measures

Measure	J-Plasma n=55 Participants Each study subject received one procedure with J-Plasma at enrollment. J-Plasma: Dermal resurfacing procedure with J-Plasma.
Evaluation of Pain and Discomfort	-3.8 score on a scale Standard Deviation 3.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 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."

Outcome measures

Measure	J-Plasma n=55 Participants Each study subject received one procedure with J-Plasma at enrollment. J-Plasma: Dermal resurfacing procedure with J-Plasma.
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	50 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 3 months

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.

Outcome measures

Measure	J-Plasma n=55 Participants Each study subject received one procedure with J-Plasma at enrollment. J-Plasma: Dermal resurfacing procedure with J-Plasma.
Mean Change in Fitzpatrick Wrinkle and Elastosis Scale (FWS) From Baseline to 3-month Follow-up Visit	-2.13 units on a scale Standard Deviation 1.02

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 Months

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

Outcome measures

Measure	J-Plasma n=55 Participants Each study subject received one procedure with J-Plasma at enrollment. J-Plasma: Dermal resurfacing procedure with J-Plasma.
Study Subject Satisfaction at 3-month Visit	2.5 score on a scale Standard Deviation 3.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 10 Days

Achievement of re-epithelialization by facial zone and across facial zones after treatment

Outcome measures

Measure	J-Plasma n=55 Participants Each study subject received one procedure with J-Plasma at enrollment. J-Plasma: Dermal resurfacing procedure with J-Plasma.
Achievement of Re-epithelialization - 10 Days	96.8 percentage of re-epithelialization Standard Deviation 5.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 Month

Achievement of re-epithelialization by facial zone and across facial zones after treatment

Outcome measures

Measure	J-Plasma n=55 Participants Each study subject received one procedure with J-Plasma at enrollment. J-Plasma: Dermal resurfacing procedure with J-Plasma.
Achievement of Re-epithelialization - 1 Month	100 percentage of re-epithelialization Standard Deviation 0.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 3 Months

Population: Data were not collected at 3 months since all subjects had reported 100% re-epithelization prior to 3 months.

Achievement of re-epithelialization by facial zone and across facial zones after treatment

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 3 months

Mean duration for study subject to feel comfortable in public after treatment as reported by the subject

Outcome measures

Measure	J-Plasma n=55 Participants Each study subject received one procedure with J-Plasma at enrollment. J-Plasma: Dermal resurfacing procedure with J-Plasma.
Mean Duration for Study Subject to Feel Comfortable in Public After Treatment	8.5 days Standard Deviation 2.5

OTHER_PRE_SPECIFIED outcome

Timeframe: Pre-procedure, post-procedure and Daily through 10 Day Follow-up Visit, approximately 9-14 days

Population: Pain scores on the Visual Analog Scale (VAS) were recorded on a daily diary and analyzed out to the 10 day follow-up visit, with a visit window of 9-14 days. Not all participants recorded a VAS score for each day on the daily diary. Participants' diaries were collected at their 10 day follow-up visit.

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).

Outcome measures

Measure	J-Plasma n=55 Participants Each study subject received one procedure with J-Plasma at enrollment. J-Plasma: Dermal resurfacing procedure with J-Plasma.
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) Pre-procedure 10-point Visual Analog Scale (VAS)	0.1 score on a scale Standard Deviation 0.4
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) Immediately Post-Procedure 10-point Visual Analog	4.3 score on a scale Standard Deviation 2.6
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) Day 0 10-point Visual Analog Scale (VAS)	3.7 score on a scale Standard Deviation 3.2
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) Day 1 10-point Visual Analog Scale (VAS)	2.6 score on a scale Standard Deviation 2.6
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) Day 2 10-point Visual Analog Scale (VAS)	2.9 score on a scale Standard Deviation 2.4
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) Day 3 10-point Visual Analog Scale (VAS)	2.7 score on a scale Standard Deviation 2.2
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) Day 4 10-point Visual Analog Scale (VAS)	3.1 score on a scale Standard Deviation 2.5
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) Day 5 10-point Visual Analog Scale (VAS)	3.1 score on a scale Standard Deviation 2.6
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) Day 6 10-point Visual Analog Scale (VAS)	2.8 score on a scale Standard Deviation 2.6
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) Day 7 10-point Visual Analog Scale (VAS)	2.4 score on a scale Standard Deviation 2.2
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) Day 8 10-point Visual Analog Scale (VAS)	2.1 score on a scale Standard Deviation 2.2
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) Day 9 10-point Visual Analog Scale (VAS)	1.9 score on a scale Standard Deviation 2.3
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) Day 10 10-point Visual Analog Scale (VAS)	1.6 score on a scale Standard Deviation 2.4
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) Day 11 10-point Visual Analog Scale (VAS)	1.6 score on a scale Standard Deviation 2.5
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) Day 12 10-point Visual Analog Scale (VAS)	1.4 score on a scale Standard Deviation 2.7
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) Day 13 10-point Visual Analog Scale (VAS)	1.3 score on a scale Standard Deviation 2.5
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) Day 14 10-point Visual Analog Scale (VAS)	1.8 score on a scale Standard Deviation 3.6

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to 3 months

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.

Outcome measures

Measure	J-Plasma n=55 Participants Each study subject received one procedure with J-Plasma at enrollment. J-Plasma: Dermal resurfacing procedure with J-Plasma.
Proportion of Subjects With Correct Identification of 3-month Images	54 Participants

Adverse Events

J-Plasma

Serious events: 0 serious events

Other events: 39 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	J-Plasma n=55 participants at risk Each study subject received one procedure with J-Plasma at enrollment. J-Plasma: Dermal resurfacing procedure with J-Plasma.
Skin and subcutaneous tissue disorders Acne	9.1% 5/55 • Number of events 5 • Through 6 month follow-up visit for all enrolled subjects.
Skin and subcutaneous tissue disorders Hypersensitivity to the treatment (resulting in erythema, swelling, induration, and/or urticaria)	47.3% 26/55 • Number of events 29 • Through 6 month follow-up visit for all enrolled subjects.
Skin and subcutaneous tissue disorders Itching	7.3% 4/55 • Number of events 4 • Through 6 month follow-up visit for all enrolled subjects.
Skin and subcutaneous tissue disorders Pain	5.5% 3/55 • Number of events 3 • Through 6 month follow-up visit for all enrolled subjects.
Skin and subcutaneous tissue disorders Post-inflammatory hyperpigmentation	14.5% 8/55 • Number of events 8 • Through 6 month follow-up visit for all enrolled subjects.
Skin and subcutaneous tissue disorders Prolonged wound healing	7.3% 4/55 • Number of events 4 • Through 6 month follow-up visit for all enrolled subjects.
Skin and subcutaneous tissue disorders Sensitivity to topical care	5.5% 3/55 • Number of events 3 • Through 6 month follow-up visit for all enrolled subjects.

Additional Information

Shawn Roman/Vice President of Research and Development

Apyx Medical (formerly Bovie Medical Corporation)

Phone: 1-727-384-2323

Email: shawn.roman@apyxmedical.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place