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.

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.