An interventional study of J-Plasma in Facial Wrinkles and Rhytides, sponsored by Apyx Medical. Completed at 3 sites in United States. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2022-07-27.
Sponsored by Apyx Medical · Not applicable, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Each study subject will receive one procedure with J-Plasma at enrollment.
Device: J-Plasma
Dermal resurfacing procedure with J-Plasma.
Also known as: Cold Helium Plasma
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.
Time frame: Baseline to 3 months
Adverse Event Rate and Duration
Adverse event rates, categorized by duration
Time frame: Up to 3 months
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."
Time frame: Baseline to 3 months
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.
Time frame: Baseline to 3 months
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."
Time frame: Baseline to 3 months
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.
Time frame: Baseline to 3 months
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
Time frame: 3 Months
Achievement of Re-epithelialization - 10 Days
Achievement of re-epithelialization by facial zone and across facial zones after treatment
Time frame: 10 Days
Achievement of Re-epithelialization - 1 Month
Achievement of re-epithelialization by facial zone and across facial zones after treatment
Time frame: 1 Month
Achievement of Re-epithelialization - 3 Months
Achievement of re-epithelialization by facial zone and across facial zones after treatment
Time frame: 3 Months
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
Time frame: Up to 3 months
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).
Time frame: Pre-procedure, post-procedure and Daily through 10 Day Follow-up Visit, approximately 9-14 days
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.
Time frame: Baseline to 3 months
| Milestone | J-Plasma |
|---|---|
| Started | 55 |
| Completed | 55 |
| Not completed | 0 |
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.
| Participants | J-Plasma |
|---|---|
| Improvement in Fitzpatrick Wrinkle and Elastosis Scale (FWS) Score | 51 |
Adverse event rates, categorized by duration
| percentage of adverse events | J-Plasma |
|---|---|
| Percentage of Serious Adverse Events | 0 |
| Percentage of Adverse Events Resolved in 7 Days | 41.8 |
| Percentage Adverse Events Resolved in 14 Days | 58 |
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."
| Participants | 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 |
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.
| score on a scale | J-Plasma |
|---|---|
| Evaluation of Pain and Discomfort | -3.8 ± 3.0 |
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."
| Participants | 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 |
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.
| units on a scale | J-Plasma |
|---|---|
| Mean Change in Fitzpatrick Wrinkle and Elastosis Scale (FWS) From Baseline to 3-month Follow-up Visit | -2.13 ± 1.02 |
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
| score on a scale | J-Plasma |
|---|---|
| Study Subject Satisfaction at 3-month Visit | 2.5 ± 3.0 |
Achievement of re-epithelialization by facial zone and across facial zones after treatment
| percentage of re-epithelialization | J-Plasma |
|---|---|
| Achievement of Re-epithelialization - 10 Days | 96.8 ± 5.7 |
Achievement of re-epithelialization by facial zone and across facial zones after treatment
| percentage of re-epithelialization | J-Plasma |
|---|---|
| Achievement of Re-epithelialization - 1 Month | 100 ± 0.0 |
Achievement of re-epithelialization by facial zone and across facial zones after treatment
No measurements were reported for this outcome.
Mean duration for study subject to feel comfortable in public after treatment as reported by the subject
| days | J-Plasma |
|---|---|
| Mean Duration for Study Subject to Feel Comfortable in Public After Treatment | 8.5 ± 2.5 |
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).
| score on a scale | J-Plasma |
|---|---|
| Pre-procedure 10-point Visual Analog Scale (VAS) | 0.1 ± 0.4 |
| Immediately Post-Procedure 10-point Visual Analog | 4.3 ± 2.6 |
| Day 0 10-point Visual Analog Scale (VAS) | 3.7 ± 3.2 |
| Day 1 10-point Visual Analog Scale (VAS) | 2.6 ± 2.6 |
| Day 2 10-point Visual Analog Scale (VAS) | 2.9 ± 2.4 |
| Day 3 10-point Visual Analog Scale (VAS) | 2.7 ± 2.2 |
| Day 4 10-point Visual Analog Scale (VAS) | 3.1 ± 2.5 |
| Day 5 10-point Visual Analog Scale (VAS) | 3.1 ± 2.6 |
| Day 6 10-point Visual Analog Scale (VAS) | 2.8 ± 2.6 |
| Day 7 10-point Visual Analog Scale (VAS) | 2.4 ± 2.2 |
| Day 8 10-point Visual Analog Scale (VAS) | 2.1 ± 2.2 |
| Day 9 10-point Visual Analog Scale (VAS) | 1.9 ± 2.3 |
| Day 10 10-point Visual Analog Scale (VAS) | 1.6 ± 2.4 |
| Day 11 10-point Visual Analog Scale (VAS) | 1.6 ± 2.5 |
| Day 12 10-point Visual Analog Scale (VAS) | 1.4 ± 2.7 |
| Day 13 10-point Visual Analog Scale (VAS) | 1.3 ± 2.5 |
| Day 14 10-point Visual Analog Scale (VAS) | 1.8 ± 3.6 |
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.
| Participants | J-Plasma |
|---|---|
| Proportion of Subjects With Correct Identification of 3-month Images | 54 |
Collected over Through 6 month follow-up visit for all enrolled subjects.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| J-Plasma | 0/55 (0%) | 0/55 (0%) | 39/55 (70.9%) |
| Event | J-Plasma |
|---|---|
| Hypersensitivity to the treatment (resulting in erythema, swelling, induration, and/or urticaria)Skin and subcutaneous tissue disorders | 26/55 |
| Post-inflammatory hyperpigmentationSkin and subcutaneous tissue disorders | 8/55 |
| AcneSkin and subcutaneous tissue disorders | 5/55 |
| ItchingSkin and subcutaneous tissue disorders | 4/55 |
| Prolonged wound healingSkin and subcutaneous tissue disorders | 4/55 |
| PainSkin and subcutaneous tissue disorders | 3/55 |
| Sensitivity to topical careSkin and subcutaneous tissue disorders | 3/55 |
| Age, Categorical(Participants) | J-Plasma |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 37 |
| >=65 years | 18 |
| Age, Continuous(years) | J-Plasma |
|---|---|
| Mean | 61.5 (31 to 82) |
| Sex: Female, Male(Participants) | J-Plasma |
|---|---|
| Female | 51 |
| Male | 4 |
| Race/Ethnicity, Customized(Participants) | J-Plasma |
|---|---|
| American Indian/Alaskan Native | 1 |
| Hispanic or Latino | 10 |
| White | 48 |
| Region of Enrollment(participants) | J-Plasma |
|---|---|
| United States | 55 |
| Fitzpatrick Wrinkle and Elastosis Scale (FWS) Score(Participants) | J-Plasma |
|---|---|
| Baseline FWS Score = 1 | 1 |
| Baseline FWS Score = 2 | 2 |
| Baseline FWS Score = 3 | 1 |
| Baseline FWS Score = 4 | 10 |
| Baseline FWS Score = 5 | 4 |
| Baseline FWS Score = 6 | 1 |
| Baseline FWS Score = 7 | 8 |
| Baseline FWS Score = 8 | 20 |
| Baseline FWS Score = 9 | 8 |
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Plan to share: No — The Sponsor does not plan to make individual participant data (IPD) available to other researchers.
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