Study To Assess A Radiofrequency Microneedling Device For Dermatologic Conditions

Study Overview
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Brief Summary
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Subjects are to be enrolled in this clinical study if they are 18 - 55 years old. Up to 120 subjects will be enrolled at multiple study centers. Subjects may receive up to 5 treatments for a wide array of dermatologic conditions in which electrocoagulation and hemostasis is a viable mechanism for means of improvement.

Official Title
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Feasibility Study To Assess A Radiofrequency Microneedling Device For Electrocoagulation And Hemostasis Of Soft Tissues For Dermatologic Conditions

Conditions
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Wrinkle, Fine Lines, Crepey Skin, Acne Scars, Acne, Enlarged Pores, Stretch Marks, Loose Skin

Intervention / Treatment
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* Device: Potenza


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A healthy, non-smoking male or female between the age of 18-55 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 6 months prior to entering this study. The subject has physical problems such as cardiovascular disorders. The subject has a pacemaker. The subject had previous use of gold thread skin rejuvenation. The subject has skin infections. The subject has any of the following conditions: Diabetes Epilepsy Acute disease Dermatitis Subjects with electronic implants such as cardiac defibrillator. It may interfere with 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 confound study results or may interfere significantly with the subject's participation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment with Device<br>Subjects received up to 5 treatments with the device, spaced 4 weeks apart. | Device: Potenza<br>* Subjects are treated with the Potenza™ device if they present with conditions such as, but not limited to: wrinkles, fine lines, crepey skin, acne scars, active acne, enlarged pores, stretch marks, or loose skin on the face, neck and/or body.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject Satisfaction | Subjects were asked to grade their satisfaction with the results of the treatment as either extremely dissatisfied, dissatisfied, slightly dissatisfied, slightly satisfied, satisfied, or extremely satisfied. | 30 day follow up | 
| Global Aesthetic Improvement Scale Assessment (GAIS) Assessment | The Clinical Global Aesthetic Improvement Scale (CGAIS) ranging from worse to very much improved is be used to judge the improvement as seen by the treating Investigator. The Investigator compared the baseline (pre-treatment) photographs to the follow up photographs to determine if the follow up image looks worse, if there is no change, if there is improvement, if there is much improvement, or if there is very much improvement in the follow up image when compared to the baseline image. | 30 day follow up | 
| Subject Satisfaction | Subjects were asked to grade their satisfaction with the results of the treatment as either extremely dissatisfied, dissatisfied, slightly dissatisfied, slightly satisfied, satisfied, or extremely satisfied. | 90 day follow up | 
| Global Aesthetic Improvement Scale Assessment (GAIS) Assessment | The Clinical Global Aesthetic Improvement Scale (CGAIS) ranging from worse to very much improved is be used to judge the improvement as seen by the treating Investigator. The Investigator compared the baseline (pre-treatment) photographs to the follow up photographs to determine if the follow up image looks worse, if there is no change, if there is improvement, if there is much improvement, or if there is very much improvement in the follow up image when compared to the baseline image. | 90 day follow up |