The Use of J-Plasma® for Dermal Resurfacing

Completed · Not applicable

Conditions studied: Facial Wrinkles, Rhytides

In brief

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.

Key facts

Study ID

NCT03286283

Run by

Apyx Medical

People needed

55

Starts

2018-01-22

Expected to finish

2018-11-16

Last updated by the study team

2022-07-27

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

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.
• Subject has undergone a facelift procedure or received facial injections within the past year.

Where it is running

• Miami Plastic Surgery — Miami, Florida, United States
• Institute for Integrated Aesthetics — Sarasota, Florida, United States
• Atlanta Dermatology, Vein & Research Center — Alpharetta, Georgia, United States

Full record on ClinicalTrials.gov

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