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

NCT06023303 | Completed FDA Device

• 1 other identifier: 7043-PM01-2023
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Dermatologic Conditions

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

Group A- Split face

EXPERIMENTAL

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; Device: Morpheus

Group B- none split face

EXPERIMENTAL

Group B will receive treatments on the face, abdomen, and/or back with Potenza and/or Morpheus.

Device: Potenza; Device: Morpheus

Interventions

Potenza DEVICE

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.

Group A- Split face; Group B- none split face

Morpheus DEVICE

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.

Group A- Split face; Group B- none split face

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cynosure, Inc.: lead

Study Sites (1)

Cynosure, Inc

Westford, Massachusetts, 01886, United States

Location

Study Officials

• Sean Doherty

  Cynosure, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subjects do not know which side of the face will be treated with either of the devices.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: September 5, 2023
• Study Start: June 21, 2023
• Primary Completion: August 10, 2023
• Study Completion: August 10, 2023
• Last Updated: January 9, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)