The Use of J-Plasma® for Dermal Resurfacing

NCT ID: NCT03286283

Last Updated: 2022-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-22
• Study Completion Date: 2018-11-16

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.

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.

Conditions

Facial Wrinkles; Rhytides

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

J-Plasma

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

Group Type: EXPERIMENTAL

J-Plasma

Intervention Type: DEVICE

Dermal resurfacing procedure with J-Plasma.

Interventions

J-Plasma

Dermal resurfacing procedure with J-Plasma.

Intervention Type: DEVICE

Other Intervention Names

Cold Helium Plasma

Eligibility 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.

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Apyx Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cindy Ponce, BS(ACS)

Role: STUDY_DIRECTOR

Apyx Medical (formerly Bovie Medical Corporation)

Locations

Miami Plastic Surgery

Miami, Florida, United States

Institute for Integrated Aesthetics

Sarasota, Florida, United States

Atlanta Dermatology, Vein & Research Center

Alpharetta, Georgia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 32350901 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

VP-1558

Identifier Type: -

Identifier Source: org_study_id