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

• ClinicalTrials.gov Identifier: NCT06023303
• Recruitment Status: Completed
• First Posted: September 5, 2023
• Last Update Posted: January 9, 2024
• Sponsor: Cynosure, Inc.
• Information provided by (Responsible Party): Cynosure, Inc.

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Dermatologic Conditions	Device: Potenza; Device: Morpheus	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 8 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Subjects will be treated with the Potenza device on one side of the face and will receive treatment with Morpheus device on the other side of the face.
• Masking: Single (Participant)
• Masking Description: Subjects do not know which side of the face will be treated with either of the devices.
• Primary Purpose: Treatment
• Official Title: Prospective Clinical Study to Assess Safety and to Collect Data on Radiofrequency Microneedling Device(s) For the Purpose of Evaluating Treatment on Skin
• Actual Study Start Date: June 21, 2023
• Actual Primary Completion Date: August 10, 2023
• Actual Study Completion Date: August 10, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Maximum pain reported during treatment. [ Time Frame: procedure (during device treatment) ]
   The maximum pain during treatment per each device will be reported on a scale of 0 (none) to 10 (maximum intolerable pain).

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Massachusetts

Cynosure, Inc

Westford, Massachusetts, United States, 01886

Sponsors and Collaborators

Cynosure, Inc.

Investigators

• Principal Investigator: Sean Doherty; Cynosure, LLC

More Information

• Responsible Party: Cynosure, Inc.
• ClinicalTrials.gov Identifier: NCT06023303
• Other Study ID Numbers: 7043-PM01-2023
• First Posted: September 5, 2023
• Last Update Posted: January 9, 2024
• Last Verified: January 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Additional relevant MeSH terms:

Skin Diseases