Change in Skin Elasticity With RF and PEMF

Study Overview
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Brief Summary
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This study will measure the difference in skin elasticity in females only before and after treatment with radiofrequency and pulsed electromagnetic field therapy.

Detailed Description
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This study is an open-label, baseline-controlled, single-center study to measure the change in skin elasticity after combined radio frequency (RF) and pulsed electromagnetic field (PEMF) treatment. Forty-five adult females will undergo weekly treatments over a period of 8 weeks. Skin elasticity will be measured by a Cutometer® prior to beginning treatment, week 7 and 3 months after completion of treatment. Photographs will be taken prior to treatment, at week 4, week 7 and 3 months after completion of treatment. Patient discomfort/pain and satisfaction questionnaires will be completed before, during and after treatment.

Official Title
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Change in Skin Elasticity After Combined Radiofrequency and Electromagnetic Treatment

Conditions
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Skin Abnormalities

Intervention / Treatment
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* Device: Cutometer
* Other: Photographs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult female subject, 18 years of age and older with Fitzpatrick skin types I-IV Ability to tolerate the RF/PEMF procedure, and willing to adhere to the treatment regimen Exclusion Criteria: Having any active electrical implant or permanent implant anywhere in the body, e.g. pacemaker, internal defibrillator Prior use of retinoids in treated area within 2 weeks of initial treatment Use of oral Isotretinoin (Accutane®) within 6 months of initial treatment Patient on systemic corticosteroid therapy 6 months prior to start of study Prior use of collagen, fat injections and /or other methods of skin augmentation (enhancement with injected or implanted material) in treated area within 4-6 weeks of initial treatment. Treatment may not be performed at all over permanent dermal implants. Prior ablative resurfacing procedure in treated area with laser or other devices within 12 months of initial treatment Any other surgery in treated area within 12 months of initial treatment History of keloid formation or poor wound healing in a previously injured skin area Epidermal or dermal disorders Open laceration or abrasion of any sort on the area to be treated. History of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or use of immunosuppressive medications. Having any form of active cancer at the time of enrollment Significant concurrent illness, such as uncontrolled diabetes i.e. any disease state that in the opinion of the Investigator would interfere with the treatment, or healing process Participation in a study of another device or drug within 1 month prior to study enrollment Tattoos in the treatment area.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: RF and PEMF therapy<br>Each subject is to receive 8 weekly study treatments. The study treatment consists of Glide (medical grade glycerin) being applied thoroughly to the study treatment area (face). The energy will be delivered by the Diamondpolar applicator attached to the Venus Versa, a medical device approved by health regulatory authorities, to deliver combined radiofrequency (RF) and pulsed electromagnetic field (PEMF) energies. Change in skin elasticity will be measured by Cutometer. Change in appearance will be assessed by independent reviewer using photographs. | Device: Cutometer<br>* Skin elasticity will be measured by a Cutometer prior to beginning treatment, week 7 and 3 months after completion of the treatment.<br>Other: Photographs<br>* Photographs will be taken prior to beginning treatment, week 7 and 3 months after completion of the treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Facial Skin Elasticity | A Cutometer® will be used to measure the change in gross elasticity (R2) of the facial skin as calculated by Ua/Uf which is a ratio of maximum recovery (Ua) and skin distensibility (Uf). The value is expressed as a percentage, the closer the value is to 1 (100%), the more elastic the skin. | 20 weeks after the last study treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Subject Satisfaction With Facial Skin Laxity Compared to Baseline as Measured by the 5-point Likert Satisfaction Scale | Subject will assign a score that best represents the level of satisfaction they have in their appearance as a result of the study treatment. The scale reports five categories - 4 - very satisfied; 3 - satisfied; 2 - having no opinion; 1 - unsatisfied and 0 - very unsatisfied. The higher the score, the more satisfaction with the treatment that a subject reports. | 7 weeks and 20 weeks post study treatments | 
| General Aesthetic Improvement Scale (GAIS) | Subject to assess their general improvement in appearance at 7 and 20 weeks post-intervention using a 7 category scale: 3 - very much improved; 2 - much improved; 1 - improved; 0 - no change; -1 - worse; -2 - much worse and -3 very much worse. The higher the positive score, the more the subject feels their appearance has changed for the better. | 7 weeks and 20 weeks post study treatments. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rhytides, wrinkle