Status:
COMPLETED
The Use of J-Plasma® for Dermal Resurfacing
Lead Sponsor:
Apyx Medical
Conditions:
Facial Wrinkles
Rhytides
Eligibility:
All Genders
30+ years
Phase:
NA
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...
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 st...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 16 2018
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT03286283
Start Date
January 22 2018
End Date
November 16 2018
Last Update
July 27 2022
Active Locations (3)
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1
Miami Plastic Surgery
Miami, Florida, United States, 33176
2
Institute for Integrated Aesthetics
Sarasota, Florida, United States, 34237
3
Atlanta Dermatology, Vein & Research Center
Alpharetta, Georgia, United States, 30022