Prospective Clinical Study to Assess Safety and to Collect Data on Radiofrequency Microneedling Device(s) For the Purpose of Evaluating Treatment on Skin

The goal of the Radiofrequency microneedling devices (Potenza and Morpheus) used in this study is to collect clinical data for dermatologic conditions in which electrocoagulation and hemostasis is a viable mechanism for means of improvement.

Study Overview

• Status: Completed
• Conditions: Dermatologic Conditions
• Intervention / Treatment: Device: Potenza; Device: Morpheus

Detailed Description

Up to 20 subjects will be enrolled at 1 study center. Subjects will be enrolled into one of 2 groups. Group A will receive split face treatments with the Potenza and Morpheus. Group B will receive treatments on the face, abdomen, and/or back with Potenza and/or Morpheus. Subjects will attend a screening/pretreatment visit which may be performed on the same day as the treatment visit. Subjects will receive up to 3 treatments with Potenza (and Morpheus).

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Westford, Massachusetts, United States, 01886
      • Cynosure, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• A healthy male or female between the age of 18-65 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.

Exclusion Criteria:

• 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 1 month prior to entering this study.
• The subject has received fillers or neurotoxin injections within the past 3 months.
• The subject has a Pacemaker.
• The subject had previous use of gold thread skin rejuvenation.
• The subject has a cut, wound, or infected skin on the area to be treated (but skin eruptions may be treated).
• The subject has a metal implant that interferes with the transmission of energy to the electrical field.
• The subject has any embedded electronic devices that give or receive a signal.
• The subject has Implantable Cardiac Defibrillators (ICD) or Cardiac Resynchronization Therapy (CRT) devices: treatment may interfere with the functionality of the device and/or damage the electronic implant.
• The subject is allergic to adhesives such as glues on medical tape: they should be alerted that a rash may occur on the neutral electronic monitoring pad (NEM or neutral pad) site, and an over-the-counter preparation may be used to treat the area.
• The subject is allergic to gold.
• The subject has an unrealistic expectation of the results: this is not plastic surgery, and all subjects should be fully informed of the treatment's expected results.
• The subject has nerve insensitivity to heat in the treatment area or in the neutral pad placement area.
• The subject has severe laxity or sagging that causes redundant folds of tissue or hanging skin in the area to be treated: this treatment will be ineffective.
• The subject has used Accutane (isotretinoin) six to twelve months prior to treatment, as this can thin the skin and make it brittle.
• The subject is taking aspirin or are currently taking antiplatelets, thrombolytics, anti-inflammatories or anticoagulants.
• The subject has a history of bleeding coagulopathies.
• The subject is allergic to topical anesthetic.
• The subject has keloid formation propensity.
• Subjects with electronic implants such as cardiac defibrillator. It may interfere with the 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 confuse study results or may interfere significantly with the subject's participation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A- Split face; Group A will receive split face treatments with the Potenza and Morpheus. Randomization will not be used for enrolling subjects to a group but will be used for Group A to determine which side of the face will receive which device.	Device: Potenza; The Radiofrequency microneedling device will be used for treating several skin problems. It is mostly used on the face and neck, specifically to treat jowls and firm the jawline, under aye area, and around the mouth.; Device: Morpheus; The Radiofrequency microneedling device will be used for treating several skin problems. It is mostly used on the face and neck, specifically to treat jowls and firm the jawline, under aye area, and around the mouth.
Experimental: Group B- none split face; Group B will receive treatments on the face, abdomen, and/or back with Potenza and/or Morpheus.	Device: Potenza; The Radiofrequency microneedling device will be used for treating several skin problems. It is mostly used on the face and neck, specifically to treat jowls and firm the jawline, under aye area, and around the mouth.; Device: Morpheus; The Radiofrequency microneedling device will be used for treating several skin problems. It is mostly used on the face and neck, specifically to treat jowls and firm the jawline, under aye area, and around the mouth.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum pain reported during treatment.	The maximum pain during treatment per each device will be reported on a scale of 0 (none) to 10 (maximum intolerable pain).	procedure (during device treatment)

Collaborators and Investigators

• Sponsor: Cynosure, Inc.
• Investigators: Principal Investigator: Sean Doherty, Cynosure, LLC

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2023
• Primary Completion (Actual): August 10, 2023
• Study Completion (Actual): August 10, 2023

Study Registration Dates

• First Submitted: August 15, 2023
• First Submitted That Met QC Criteria: September 1, 2023
• First Posted (Actual): September 5, 2023

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases
• Other Study ID Numbers: 7043-PM01-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes