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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| J-Plasma | Experimental | Each study subject will receive one procedure with J-Plasma at enrollment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| J-Plasma | Device | Dermal resurfacing procedure with J-Plasma. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Adverse Event Rate and Duration | Adverse event rates, categorized by duration | Up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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." |
| Measure | Description | Time Frame |
|---|---|---|
| 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." |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cindy Ponce, BS(ACS) | Apyx Medical (formerly Bovie Medical Corporation) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami Plastic Surgery | Miami | Florida | 33176 | United States | ||
| Institute for Integrated Aesthetics |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32350901 | Derived | 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. |
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The Sponsor does not plan to make individual participant data (IPD) available to other researchers.
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All participants who were enrolled were assigned to a/the treatment group.
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| ID | Title | Description |
|---|---|---|
| FG000 | J-Plasma | Each study subject will receive one procedure with J-Plasma at enrollment. J-Plasma: Dermal resurfacing procedure with J-Plasma. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | J-Plasma | Each study subject received one procedure with J-Plasma at enrollment. J-Plasma: Dermal resurfacing procedure with J-Plasma. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Adults 30 years of age or older who provided informed consent and who met the inclusion/exclusion criteria. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | Baseline to 3 months |
|
|
Through 6 month follow-up visit for all enrolled subjects.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | J-Plasma | Each study subject received one procedure with J-Plasma at enrollment. J-Plasma: Dermal resurfacing procedure with J-Plasma. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acne | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shawn Roman/Vice President of Research and Development | Apyx Medical (formerly Bovie Medical Corporation) | 1-727-384-2323 | shawn.roman@apyxmedical.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 5, 2018 | May 28, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 28, 2018 | Jul 10, 2019 | SAP_001.pdf |
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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.
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This is a single-arm study in which investigators are not blinded. However, blinded Independent Photographic Reviewers (IPR) will be utilized to review all images (baseline and all follow-up time points) and assign FWS scores.
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| 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. | Baseline to 3 months |
| 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. | 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 | 3 Months |
| Achievement of Re-epithelialization - 10 Days | Achievement of re-epithelialization by facial zone and across facial zones after treatment | 10 Days |
| Achievement of Re-epithelialization - 1 Month | Achievement of re-epithelialization by facial zone and across facial zones after treatment | 1 Month |
| Achievement of Re-epithelialization - 3 Months | Achievement of re-epithelialization by facial zone and across facial zones after treatment | 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 | 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). | 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. | Baseline to 3 months |
| Sarasota |
| Florida |
| 34237 |
| United States |
| Atlanta Dermatology, Vein & Research Center | Alpharetta | Georgia | 30022 | United States |
| Count of Participants |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Race/Ethnicity are not mutually exclusive categories. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Fitzpatrick Wrinkle and Elastosis Scale (FWS) Score | Participants' Average Fitzpatrick Wrinkle and Elastosis Scale (FWS) score at baseline as determined by Independent Photographic Reviewers; the FWS is a scale of 1 to 9 where 9 represents the highest severity of wrinkles and rhytides and 1 represents the lowest severity of wrinkles and rhytides. | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| Primary | Adverse Event Rate and Duration | Adverse event rates, categorized by duration | Posted | Number | percentage of adverse events | 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." | Posted | Count of Participants | Participants | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 3 months |
|
|
|
| Other Pre-specified | 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." | Posted | Count of Participants | Participants | Baseline to 3 months |
|
|
|
| Other Pre-specified | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline to 3 months |
|
|
|
| Other Pre-specified | 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 | Posted | Mean | Standard Deviation | score on a scale | 3 Months |
|
|
|
| Other Pre-specified | Achievement of Re-epithelialization - 10 Days | Achievement of re-epithelialization by facial zone and across facial zones after treatment | Posted | Mean | Standard Deviation | percentage of re-epithelialization | 10 Days |
|
|
|
| Other Pre-specified | Achievement of Re-epithelialization - 1 Month | Achievement of re-epithelialization by facial zone and across facial zones after treatment | Posted | Mean | Standard Deviation | percentage of re-epithelialization | 1 Month |
|
|
|
| Other Pre-specified | Achievement of Re-epithelialization - 3 Months | Achievement of re-epithelialization by facial zone and across facial zones after treatment | Data were not collected at 3 months since all subjects had reported 100% re-epithelization prior to 3 months. | Posted | 3 Months |
|
|
| Other Pre-specified | 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 | Posted | Mean | Standard Deviation | days | Up to 3 months |
|
|
|
| Other Pre-specified | 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). | 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. | Posted | Mean | Standard Deviation | score on a scale | Pre-procedure, post-procedure and Daily through 10 Day Follow-up Visit, approximately 9-14 days |
|
|
|
| Other Pre-specified | 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. | Posted | Count of Participants | Participants | Baseline to 3 months |
|
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|
| 0 |
| 55 |
| 0 |
| 55 |
| 39 |
| 55 |
| Hypersensitivity to the treatment (resulting in erythema, swelling, induration, and/or urticaria) | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Pain | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Post-inflammatory hyperpigmentation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Prolonged wound healing | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Sensitivity to topical care | Skin and subcutaneous tissue disorders | Systematic Assessment |
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