WrinkleNCT05097157

Study To Assess A Radiofrequency Microneedling Device For Dermatologic Conditions

A study testing Potenza in people with Wrinkle and Fine Lines, run by Cynosure, Inc. at 4 sites in United States.

Completed

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

Trial summary

Subjects are to be enrolled in this clinical study if they are 18 - 55 years old. Up to 120 subjects will be enrolled at multiple study centers. Subjects may receive up to 5 treatments for a wide array of dermatologic conditions in which electrocoagulation and hemostasis is a viable mechanism for means of improvement. Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Wrinkle, Fine Lines, Crepey Skin
What is being tested?: Potenza
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 79 participants
Where: 4 sitesUnited States
Study dates: 3 Sep 2019to 21 Jun 2021
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 18 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

A healthy, non-smoking male or female between the age of 18-55 years old.
Fitzpatrick skin type I to VI.
Understands and accepts obligation not to receive any other procedures on the treatment area through the length of the study.
Understands and accepts the obligation and is logistically able to be present for all visits.
Is willing to comply with all requirements of the study and sign the informed consent document.

Who cannot join

Is pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the study.
The subject is currently enrolled in an investigational drug or device trial or has received an investigational drug or been treated with an investigational device within in the area to be treated 6 months prior to entering this study.
The subject has physical problems such as cardiovascular disorders.
The subject has a pacemaker.
The subject had previous use of gold thread skin rejuvenation.
The subject has skin infections.

Show all 13Show fewer

The subject has any of the following conditions:
Diabetes
Epilepsy
Acute disease
Dermatitis
Subjects with electronic implants such as cardiac defibrillator. It may interfere with operation of electronic implants or damage the implants, causing risks.
The subject has any condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound study results or may interfere significantly with the subject's participation.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Maryland Dermatology Laser, Skin, & Vein Institute, LLC.
Hunt Valley, Maryland, 21030
Center for Dermatology and Laser Surgery
Sacramento, California, 95819
McDaniel Institute of Anti-Aging Research
Virginia Beach, Virginia, 23462
Cynosure
Westford, Massachusetts, 01886

Other trials in United States

About this study

Official title: Feasibility Study To Assess A Radiofrequency Microneedling Device For Electrocoagulation And Hemostasis Of Soft Tissues For Dermatologic Conditions

Conditions: Wrinkle, Fine Lines, Crepey Skin, Acne Scars, Acne, Enlarged Pores
Being tested: Potenza
Medical subject headings: Acne Vulgaris, Striae Distensae, Cutis Laxa

What participants receive

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

PotenzaDevice
Subjects are treated with the Potenza™ device if they present with conditions such as, but not limited to: wrinkles, fine lines, crepey skin, acne scars, active acne, enlarged pores, stretch marks, or loose skin on the face, neck and/or body.

Study groups in NCT05097157
Study group	Role	What they receive
Treatment with Device	Experimental	Subjects received up to 5 treatments with the device, spaced 4 weeks apart. Receives: Device: Potenza

What is being measured

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

Subject Satisfaction
Subjects were asked to grade their satisfaction with the results of the treatment as either extremely dissatisfied, dissatisfied, slightly dissatisfied, slightly satisfied, satisfied, or extremely satisfied.
Measured: 30 day follow up
Global Aesthetic Improvement Scale Assessment (GAIS) Assessment
The Clinical Global Aesthetic Improvement Scale (CGAIS) ranging from "worse" to "very much improved" is be used to judge the improvement as seen by the treating Investigator. The Investigator compared the baseline (pre-treatment) photographs to the follow up photographs to determine if the follow up image looks worse, if there is no change, if there is improvement, if there is much improvement, or if there is very much improvement in the follow up image when compared to the baseline image.
Measured: 30 day follow up
Subject Satisfaction
Subjects were asked to grade their satisfaction with the results of the treatment as either extremely dissatisfied, dissatisfied, slightly dissatisfied, slightly satisfied, satisfied, or extremely satisfied.
Measured: 90 day follow up
Global Aesthetic Improvement Scale Assessment (GAIS) Assessment
The Clinical Global Aesthetic Improvement Scale (CGAIS) ranging from "worse" to "very much improved" is be used to judge the improvement as seen by the treating Investigator. The Investigator compared the baseline (pre-treatment) photographs to the follow up photographs to determine if the follow up image looks worse, if there is no change, if there is improvement, if there is much improvement, or if there is very much improvement in the follow up image when compared to the baseline image.
Measured: 90 day follow up

Timeline

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

3 Sep 201921 Jun 2021

First posted28 Oct 2021
Study start3 Sep 2019
Primary completion12 Apr 2021
Study completion21 Jun 2021

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 WrinkleStudies 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
Masking: None (open label)
Enrolment: 79 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05097157
Sponsor's protocol ID: CYN19-RF-MN-01
Status last verified: May 2022
First submitted: 15 Oct 2021
Last updated: 9 Jun 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Gupta V, Sharma VK. Skin typing: Fitzpatrick grading and others. Clin Dermatol. 2019 Sep-Oct;37(5):430-436. doi: 10.1016/j.clindermatol.2019.07.010. Epub 2019 Jul 17.
PubMed 31896400

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?

See locations

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All Wrinkle trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feasibility Study To Assess A Radiofrequency Microneedling Device For Electrocoagulation And Hemostasis Of Soft Tissues For Dermatologic Conditions
ClinicalTrials.gov ID: NCT05097157
Acronym / sponsor ID: CYN19-RF-MN-01
Conditions: Wrinkle, Fine Lines, Crepey Skin, Acne Scars, Acne, Enlarged Pores
Study type: Interventional
Recruitment status: Completed
Enrolment: 79 participants (actual)
Lead sponsor: Cynosure, Inc.Industry (pharma, biotech, devices)
Study start: 3 Sep 2019 (actual)
Primary completion: 12 Apr 2021 (actual)
Study completion: 21 Jun 2021 (actual)
First posted: 28 Oct 2021 (actual)
Results: Posted 9 Jun 2022

Clinical summary

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

Study design

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

Arm	Type	Receives
Treatment with Device	Experimental	Device: PotenzaSubjects received up to 5 treatments with the device, spaced 4 weeks apart.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

A healthy, non-smoking male or female between the age of 18-55 years old.
Fitzpatrick skin type I to VI.
Understands and accepts obligation not to receive any other procedures on the treatment area through the length of the study.
Understands and accepts the obligation and is logistically able to be present for all visits.
Is willing to comply with all requirements of the study and sign the informed consent document.

Key exclusion criteria (13 listed)

Is pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the study.
The subject is currently enrolled in an investigational drug or device trial or has received an investigational drug or been treated with an investigational device within in the area to be treated 6 months prior to entering this study.
The subject has physical problems such as cardiovascular disorders.
The subject has a pacemaker.
The subject had previous use of gold thread skin rejuvenation.

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
PotenzaSubjects are treated with the Potenza™ device if they present with conditions such as, but not limited to: wrinkles, fine lines, crepey skin, acne scars, active acne, enlarged pores, stretch marks, or loose skin on the face, neck and/or body.	Device	Treatment with Device

Primary outcome

Subject Satisfaction
Time frame: 30 day follow up
Subjects were asked to grade their satisfaction with the results of the treatment as either extremely dissatisfied, dissatisfied, slightly dissatisfied, slightly satisfied, satisfied, or extremely satisfied.
Global Aesthetic Improvement Scale Assessment (GAIS) Assessment
Time frame: 30 day follow up
The Clinical Global Aesthetic Improvement Scale (CGAIS) ranging from "worse" to "very much improved" is be used to judge the improvement as seen by the treating Investigator. The Investigator compared the baseline (pre-treatment) photographs to the follow up photographs to determine if the follow up image looks worse, if there is no change, if there is improvement, if there is much improvement, or if there is very much improvement in the follow up image when compared to the baseline image.
Subject Satisfaction
Time frame: 90 day follow up
Subjects were asked to grade their satisfaction with the results of the treatment as either extremely dissatisfied, dissatisfied, slightly dissatisfied, slightly satisfied, satisfied, or extremely satisfied.
Global Aesthetic Improvement Scale Assessment (GAIS) Assessment
Time frame: 90 day follow up
The Clinical Global Aesthetic Improvement Scale (CGAIS) ranging from "worse" to "very much improved" is be used to judge the improvement as seen by the treating Investigator. The Investigator compared the baseline (pre-treatment) photographs to the follow up photographs to determine if the follow up image looks worse, if there is no change, if there is improvement, if there is much improvement, or if there is very much improvement in the follow up image when compared to the baseline image.

Results and safety

Results posted to the registry on 9 Jun 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment With Device	79	56

Primary outcome: Subject Satisfaction

Time frame: 30 day follow up. Count of participants. Unit: Participants

Measure	Treatment With Device n = 50
Extremely Satisfied	7
Satisfied	21
Slightly Satisfied	15
Slightly Dissatisfied	4
Dissatisfied	2
Extremely Dissatisfied	1

Population analysed: 6 subjects were considered complete but did not have satisfaction information from their 30 day follow up.

Primary outcome: Global Aesthetic Improvement Scale Assessment (GAIS) Assessment

Time frame: 30 day follow up. Count of participants. Unit: Participants

Measure	Treatment With Device n = 44
Very Much Improved	1
Much Improved	8
Improved	27
No Change	8
Worsened	0

Population analysed: 12 subjects were considered complete but did not have satisfaction information from their 30 day follow up.

Primary outcome: Subject Satisfaction

Time frame: 90 day follow up. Number. Unit: treatment areas

Measure	Treatment With Device n = 15
Extremely Satisfied	4
Satisfied	5
Slightly Satisfied	5
Slightly Dissatisfied	1
Dissatisfied	0
Extremely Dissatisfied	1

Population analysed: 40 subjects did not complete the 90 day follow up for the subject satisfaction However, subjects who completed at least their 30 day follow up were considered complete. 1 subject had 2 different treatment areas treated and had a satisfaction score taken for both treatment areas.

Primary outcome: Global Aesthetic Improvement Scale Assessment (GAIS) Assessment

Time frame: 90 day follow up. Number. Unit: treatment areas

Measure	Treatment With Device n = 15
Very Much Improved	0
Much Improved	5
Improved	10
No Change	1
Worsened	0

Population analysed: 41 subjects did not complete the 90 day follow up for the CGAIS. However, subjects who completed at least their 30 day follow up were considered complete. 1 subject had 2 different treatment areas treated and had a CGAIS taken for both treatment areas.

Adverse events

Time frame: Subject data was collected throughout subject participation in the study, approximately 9 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment With Device	0 of 79 (0%)	37 of 79 (46.8%)	0 of 79

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 31896400Gupta V, Sharma VK. Skin typing: Fitzpatrick grading and others. Clin Dermatol. 2019 Sep-Oct;37(5):430-436. doi: 10.1016/j.clindermatol.2019.07.010. Epub 2019 Jul 17.
Individual participant dataSharing planned: No

Related trials for Wrinkle

Active, not 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.

Jennifer Civiok study director

Cynosure, Inc.

Sean Doherty principal investigator

Cynosure, Inc.

Robert Weiss principal investigator

Maryland Dermatology Laser, Skin, & Vein Institute, LLC

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

Questions about this trial

What is this clinical trial studying?

A study testing Potenza in people with Wrinkle and Fine Lines, run by Cynosure, Inc. at 4 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 5 inclusion and 13 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 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 9 Jun 2022). 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?

Subject Satisfaction (time frame: 30 day follow up). The study lists 4 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 NCT05097157, 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 9 Jun 2022.