- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03286283
The Use of J-Plasma® for Dermal Resurfacing
A Prospective, Multicenter, Single Arm Clinical Study Evaluating the Use of J-Plasma® for Dermal Resurfacing
Study Overview
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Florida
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Miami, Florida, United States, 33176
- Miami Plastic Surgery
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Sarasota, Florida, United States, 34237
- Institute for Integrated Aesthetics
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Georgia
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Alpharetta, Georgia, United States, 30022
- Atlanta Dermatology, Vein & Research Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: J-Plasma
Each study subject will receive one procedure with J-Plasma at enrollment.
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Dermal resurfacing procedure with J-Plasma.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement in Fitzpatrick Wrinkle and Elastosis Scale (FWS) Score
Time Frame: 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.
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Baseline to 3 months
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Adverse Event Rate and Duration
Time Frame: Up to 3 months
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Adverse event rates, categorized by duration
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Up to 3 months
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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.
Time Frame: 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."
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Baseline to 3 months
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Evaluation of Pain and Discomfort
Time Frame: Baseline to 3 months
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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.
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Baseline to 3 months
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Other Outcome Measures
Outcome Measure |
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
Time Frame: Baseline to 3 months
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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."
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Baseline to 3 months
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Mean Change in Fitzpatrick Wrinkle and Elastosis Scale (FWS) From Baseline to 3-month Follow-up Visit
Time Frame: Baseline to 3 months
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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.
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Baseline to 3 months
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Study Subject Satisfaction at 3-month Visit
Time Frame: 3 Months
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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
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3 Months
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Achievement of Re-epithelialization - 10 Days
Time Frame: 10 Days
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Achievement of re-epithelialization by facial zone and across facial zones after treatment
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10 Days
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Achievement of Re-epithelialization - 1 Month
Time Frame: 1 Month
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Achievement of re-epithelialization by facial zone and across facial zones after treatment
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1 Month
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Achievement of Re-epithelialization - 3 Months
Time Frame: 3 Months
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Achievement of re-epithelialization by facial zone and across facial zones after treatment
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3 Months
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Mean Duration for Study Subject to Feel Comfortable in Public After Treatment
Time Frame: Up to 3 months
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Mean duration for study subject to feel comfortable in public after treatment as reported by the subject
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Up to 3 months
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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)
Time Frame: Pre-procedure, post-procedure and Daily through 10 Day Follow-up Visit, approximately 9-14 days
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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).
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Pre-procedure, post-procedure and Daily through 10 Day Follow-up Visit, approximately 9-14 days
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Proportion of Subjects With Correct Identification of 3-month Images
Time Frame: Baseline to 3 months
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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.
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Baseline to 3 months
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Cindy Ponce, BS(ACS), Apyx Medical (formerly Bovie Medical Corporation)
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- VP-1558
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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