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The Use of J-Plasma® for Dermal Resurfacing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03286283
Recruitment Status : Completed
First Posted : September 18, 2017
Results First Posted : August 7, 2019
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
Apyx Medical

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Facial Wrinkles Rhytides Device: J-Plasma Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Intervention Model: Single Group Assignment
Intervention 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)
Masking Description: 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.
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Single Arm Clinical Study Evaluating the Use of J-Plasma® for Dermal Resurfacing
Actual Study Start Date : January 22, 2018
Actual Primary Completion Date : August 20, 2018
Actual Study Completion Date : November 16, 2018

Arm Intervention/treatment
Experimental: J-Plasma
Each study subject will receive one procedure with J-Plasma at enrollment.
Device: J-Plasma
Dermal resurfacing procedure with J-Plasma.
Other Name: Cold Helium Plasma




Primary Outcome Measures :
  1. 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.

  2. Adverse Event Rate and Duration [ Time Frame: Up to 3 months ]
    Adverse event rates, categorized by duration


Secondary Outcome Measures :
  1. 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."

  2. Evaluation of Pain and Discomfort [ Time Frame: 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.


Other Outcome Measures:
  1. 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 ]
    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."

  2. Mean Change in Fitzpatrick Wrinkle and Elastosis Scale (FWS) From Baseline to 3-month Follow-up Visit [ Time Frame: 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.

  3. Study Subject Satisfaction at 3-month Visit [ Time Frame: 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

  4. Achievement of Re-epithelialization - 10 Days [ Time Frame: 10 Days ]
    Achievement of re-epithelialization by facial zone and across facial zones after treatment

  5. Achievement of Re-epithelialization - 1 Month [ Time Frame: 1 Month ]
    Achievement of re-epithelialization by facial zone and across facial zones after treatment

  6. Achievement of Re-epithelialization - 3 Months [ Time Frame: 3 Months ]
    Achievement of re-epithelialization by facial zone and across facial zones after treatment

  7. Mean Duration for Study Subject to Feel Comfortable in Public After Treatment [ Time Frame: Up to 3 months ]
    Mean duration for study subject to feel comfortable in public after treatment as reported by the subject

  8. 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 ]
    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).

  9. Proportion of Subjects With Correct Identification of 3-month Images [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female subjects ≥30 years of age.
  2. Subject is seeking improvement of facial appearance by reducing facial wrinkles and rhytides.
  3. Subject with a facial wrinkle score rating of at least 2 on the FWS as determined by the investigator.
  4. Subject with a Fitzpatrick Skin Scale score ≤III.
  5. Subject is willing and able to provide written informed consent.
  6. Subject is willing and able to comply with protocol requirements, including obtaining study-required images/photos and assessments, and returning for follow-up visits.
  7. Subject is willing to release rights to study Sponsor for the use of the photos, including in potential publication.
  8. 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:

  1. Subject with a Fitzpatrick Skin Scale score >III.
  2. Subject is pregnant or lactating.
  3. Active HSV-1 or diabetes mellitus.
  4. Active cut, wound, or infection on the skin of the face.
  5. Subject has used, within the past 30 days, Accutane or any medication that can cause dermal hypersensitivity.
  6. Subject has a history of autoimmune disease.
  7. Subject with a bleeding disorder or who is on blood thinning medication that may be at risk for bleeding.
  8. Subject has a known adverse reaction to anesthetics.
  9. Subjects with active skin disease of the facial area or known connective tissue disease.
  10. Subjects with known susceptibility to keloid formation or hypertrophic scarring.
  11. Subjects with present cancerous or pre-cancerous lesions in the area to be treated.
  12. Subject who, for any reason, suspects that they will not be able to complete the prescribed follow-up assessment(s);
  13. 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.
  14. Subject is not willing to release rights to study Sponsor for the use of the photos, including in potential publication.
  15. Subject is enrolled in another investigational (drug or device) clinical trial that can interfere with this study's assessments.
  16. Subject has undergone a facelift procedure or received facial injections within the past year.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03286283


Locations
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United States, Florida
Miami Plastic Surgery
Miami, Florida, United States, 33176
Institute for Integrated Aesthetics
Sarasota, Florida, United States, 34237
United States, Georgia
Atlanta Dermatology, Vein & Research Center
Alpharetta, Georgia, United States, 30022
Sponsors and Collaborators
Apyx Medical
Investigators
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Study Director: Cindy Ponce, BS(ACS) Apyx Medical (formerly Bovie Medical Corporation)
  Study Documents (Full-Text)

Documents provided by Apyx Medical:
Study Protocol  [PDF] November 5, 2018
Statistical Analysis Plan  [PDF] March 28, 2018


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Responsible Party: Apyx Medical
ClinicalTrials.gov Identifier: NCT03286283     History of Changes
Other Study ID Numbers: VP-1558
First Posted: September 18, 2017    Key Record Dates
Results First Posted: August 7, 2019
Last Update Posted: August 7, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The Sponsor does not plan to make individual participant data (IPD) available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Keywords provided by Apyx Medical:
Rhytides
Wrinkle Reduction
J-Plasma
Dermal Resurfacing