The Use of J-Plasma® for Dermal Resurfacing

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Facial Wrinkles, Rhytides

Intervention / Treatment
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* Device: J-Plasma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects ≥30 years of age. Subject is seeking improvement of facial appearance by reducing facial wrinkles and rhytides. Subject with a facial wrinkle score rating of at least 2 on the FWS as determined by the investigator. Subject with a Fitzpatrick Skin Scale score ≤III. Subject is willing and able to provide written informed consent. Subject is willing and able to comply with protocol requirements, including obtaining study-required images/photos and assessments, and returning for follow-up visits. Subject is willing to release rights to study Sponsor for the use of the photos, including in potential publication. 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: Subject with a Fitzpatrick Skin Scale score >III. Subject is pregnant or lactating. Active HSV-1 or diabetes mellitus. Active cut, wound, or infection on the skin of the face. Subject has used, within the past 30 days, Accutane or any medication that can cause dermal hypersensitivity. Subject has a history of autoimmune disease. Subject with a bleeding disorder or who is on blood thinning medication that may be at risk for bleeding. Subject has a known adverse reaction to anesthetics. Subjects with active skin disease of the facial area or known connective tissue disease. Subjects with known susceptibility to keloid formation or hypertrophic scarring. Subjects with present cancerous or pre-cancerous lesions in the area to be treated. Subject who, for any reason, suspects that they will not be able to complete the prescribed follow-up assessment(s); 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. Subject is not willing to release rights to study Sponsor for the use of the photos, including in potential publication. Subject is enrolled in another investigational (drug or device) clinical trial that can interfere with this study's assessments. Subject has undergone a facelift procedure or received facial injections within the past year.

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: J-Plasma<br>Each study subject will receive one procedure with J-Plasma at enrollment. | Device: J-Plasma<br>* Dermal resurfacing procedure with J-Plasma.<br>* Other names: Cold Helium Plasma;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rhytides, Wrinkle Reduction, J-Plasma, Dermal Resurfacing