Feasibility Study To Collect Safety And Preliminary Efficacy Data For A Radiofrequency Microneedl… (NCT05254210) | Clinical Trial Compass
CompletedNot Applicable
Feasibility Study To Collect Safety And Preliminary Efficacy Data For A Radiofrequency Microneedling Device
United States10 participantsStarted 2021-09-13
Plain-language summary
The intended use of the Potenzaâ„¢ device is to collect clinical data for brow lifting and/or treatment of dermatologic conditions in which electrocoagulation and hemostasis is a viable mechanism for means of improvement.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion Criteria:
* A healthy, non-smoking male or female between the age of 18-60 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 3 months prior to entering this study.
* 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 …
What they're measuring
1
Evaluation of Baseline Photographs Compared to Post Treatment Images