Change in Skin Elasticity With RF and PEMF

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.

• Cutometer (Device): Skin elasticity will be measured by a Cutometer prior to beginning treatment, week 7 and 3 months after completion of the treatment.
• Photographs (Other): Photographs will be taken prior to beginning treatment, week 7 and 3 months after completion of the treatment.

Primary outcomes

• Change in Facial Skin Elasticity [20 weeks after the last study treatment]: 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.

Secondary outcomes

• Improvement in Subject Satisfaction With Facial Skin Laxity Compared to Baseline as Measured by the 5-point Likert Satisfaction Scale [7 weeks and 20 weeks post study treatments]: 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.
• General Aesthetic Improvement Scale (GAIS) [7 weeks and 20 weeks post study treatments.]: 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.

Sex: Female, ages: 18 Years to any, accepts healthy volunteers

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.

Participant flow

Outcome results

• Change in Facial Skin Elasticity (Primary), Mean, ratio: RF and PEMF Therapy 0.7658 +/- 0.1127
• Improvement in Subject Satisfaction With Facial Skin Laxity Compared to Baseline as Measured by the 5-point Likert Satisfaction Scale (Secondary), Mean, score on a scale: RF and PEMF Therapy 3.11 +/- 0.92
• General Aesthetic Improvement Scale (GAIS) (Secondary), Mean, score on a scale: RF and PEMF Therapy 1.19 +/- 0.92

Adverse events

Time frame: Adverse event data was collected for 9 months and 18 days. All reportable events with start dates occurring any time after informed consent is obtained will be followed until 7 (for non-serious AEs) or 30 days (for SAEs) after the last day of study participation.

• Study Protocol and Statistical Analysis Plan (PDF, 2016-11-15)

• Yoni Iger, PhD, Study director, Venus Concept Ltd.