Facial WrinklesNCT03286283

The Use of J-Plasma® for Dermal Resurfacing

A study testing J-Plasma in people with Facial Wrinkles and Rhytides, run by Apyx Medical at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 30 years and older
Conditions the study is for: Facial Wrinkles, Rhytides
What is being tested?: J-Plasma
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 55 participants
Where: 3 sitesUnited States
Study dates: 22 Jan 2018to 16 Nov 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 30 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 16Show fewer

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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Atlanta Dermatology, Vein & Research Center
Alpharetta, Georgia, 30022
Miami Plastic Surgery
Miami, Florida, 33176
Institute for Integrated Aesthetics
Sarasota, Florida, 34237

Other trials in United States

About this study

Official title: A Prospective, Multicenter, Single Arm Clinical Study Evaluating the Use of J-Plasma® for Dermal Resurfacing

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.

Read the 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
Being tested: J-Plasma
Keywords: Rhytides, Wrinkle Reduction, J-Plasma, Dermal Resurfacing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

J-PlasmaDevice
Also called Cold Helium Plasma
Dermal resurfacing procedure with J-Plasma.

Study groups in NCT03286283
Study group	Role	What they receive
J-Plasma	Experimental	Each study subject will receive one procedure with J-Plasma at enrollment. Receives: Device: J-Plasma

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline to 3 months
Adverse Event Rate and Duration
Adverse event rates, categorized by duration
Measured: 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.
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."
Measured: Baseline to 3 months
Evaluation of Pain and Discomfort
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.
Measured: Baseline to 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Jan 201816 Nov 2018

First posted18 Sep 2017
Study start22 Jan 2018
Primary completion20 Aug 2018
Study completion16 Nov 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Facial WrinklesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
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)
Enrolment: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03286283
Sponsor's protocol ID: VP-1558
Status last verified: Jul 2022
First submitted: 15 Sep 2017
Last updated: 27 Jul 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No: The Sponsor does not plan to make individual participant data (IPD) available to other researchers.

Publications

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.
PubMed 32350901

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multicenter, Single Arm Clinical Study Evaluating the Use of J-Plasma® for Dermal Resurfacing
ClinicalTrials.gov ID: NCT03286283
Acronym / sponsor ID: VP-1558
Conditions: Facial Wrinkles, Rhytides
Keywords: Rhytides, Wrinkle Reduction, J-Plasma, Dermal Resurfacing
Study type: Interventional
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: Apyx MedicalIndustry (pharma, biotech, devices)
Study start: 22 Jan 2018 (actual)
Primary completion: 20 Aug 2018 (actual)
Study completion: 16 Nov 2018 (actual)
First posted: 18 Sep 2017 (actual)
Results: Posted 7 Aug 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The study objective is to demonstrate the safety and efficacy of the J-Plasma system for use in dermal skin resurfacing.

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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
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.

Arm	Type	Receives
J-Plasma	Experimental	Device: J-PlasmaEach study subject will receive one procedure with J-Plasma at enrollment.

Who may qualify

Ages: 30 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (16 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
J-PlasmaAlso: Cold Helium PlasmaDermal resurfacing procedure with J-Plasma.	Device	J-Plasma

Primary outcome

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.
Adverse Event Rate and Duration
Time frame: Up to 3 months
Adverse event rates, categorized by duration

2 secondary outcomes

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
Evaluation of Pain and Discomfort
Time frame: Baseline to 3 months

Results and safety

Results posted to the registry on 7 Aug 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
J-Plasma	55	55

Primary outcome: Improvement in Fitzpatrick Wrinkle and Elastosis Scale (FWS) Score

Time frame: Baseline to 3 months. Count of participants. Unit: Participants

Measure	J-Plasma n = 55
Value	51

Primary outcome: Adverse Event Rate and Duration

Time frame: Up to 3 months. Number. Unit: percentage of adverse events

Measure	J-Plasma n = 55
Percentage of Serious Adverse Events	0
Percentage of Adverse Events Resolved in 7 Days	41.8
Percentage Adverse Events Resolved in 14 Days	58

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Through 6 month follow-up visit for all enrolled subjects.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
J-Plasma	0 of 55 (0%)	39 of 55 (70.9%)	0 of 55

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32350901Holcomb 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.
Individual participant dataSharing planned: No. The Sponsor does not plan to make individual participant data (IPD) available to other researchers.

Related trials for Facial Wrinkles

Active, not recruiting
Clinical Study to Evaluate the Efficacy and Safety of Matrix Pro Treatment
Skin Laxity, Wrinkle
Not yet recruiting
Effects of Probiotics on Skin Health in Healthy Women
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Not yet recruiting
Evaluation of MD60002 Device for Facial Skin Aging
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Cindy Ponce, BS(ACS) study director

Apyx Medical (formerly Bovie Medical Corporation)

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing J-Plasma in people with Facial Wrinkles and Rhytides, run by Apyx Medical at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement in Fitzpatrick Wrinkle and Elastosis Scale (FWS) Score (time frame: Baseline to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03286283, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2022.