Prospective Clinical Study to Assess Safety and to Collect Data on Radiofrequency Microneedling Device(s) For the Purpose of Evaluating Treatment on Skin
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dermatologic Conditions
- Sponsor
- Cynosure, Inc.
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Maximum pain reported during treatment.
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
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).
Investigators
Eligibility 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.
Outcomes
Primary Outcomes
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).