The Use of J-Plasma® for Dermal Resurfacing

NCT03286283 | Completed Results FDA Device

• 1 other identifier: VP-1558
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 3

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.

Conditions

Facial Wrinkles; Rhytides

Keywords

Rhytides; Wrinkle Reduction; J-Plasma; Dermal Resurfacing

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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.

  Baseline to 3 months

• Evaluation of Pain and Discomfort

  Baseline to 3 months

Other Outcomes (9)

• 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

  Baseline to 3 months

• Mean Change in Fitzpatrick Wrinkle and Elastosis Scale (FWS) From Baseline to 3-month Follow-up Visit

  Baseline to 3 months

• Study Subject Satisfaction at 3-month Visit

  3 Months

Study Arms (1)

J-Plasma

EXPERIMENTAL

Each study subject will receive one procedure with J-Plasma at enrollment.

Device: J-Plasma

Interventions

J-Plasma DEVICE

Dermal resurfacing procedure with J-Plasma.

Also known as: Cold Helium Plasma

J-Plasma

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Apyx Medical: lead

Study Sites (3)

Miami Plastic Surgery

Miami, Florida, 33176, United States

Location

Institute for Integrated Aesthetics

Sarasota, Florida, 34237, United States

Location

Atlanta Dermatology, Vein & Research Center

Alpharetta, Georgia, 30022, United States

Location

Related Publications (1)

• 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.

  PMID: 32350901 DERIVED

Results Point of Contact

• Title: Shawn Roman/Vice President of Research and Development
• Organization: Apyx Medical (formerly Bovie Medical Corporation)

shawn.roman@apyxmedical.com

1-727-384-2323

Study Officials

• Cindy Ponce, BS(ACS)

  Apyx Medical (formerly Bovie Medical Corporation)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 15, 2017
• First Posted: September 18, 2017
• Study Start: January 22, 2018
• Primary Completion: August 20, 2018
• Study Completion: November 16, 2018
• Last Updated: July 27, 2022
• Results First Posted: August 7, 2019

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)