Change in Skin Elasticity With RF and PEMF

Venus Concept

Status: Completed

Conditions: Skin Abnormalities

Treatments: Other: Photographs; Device: Cutometer

Study type: Interventional

Funder types: Industry

Identifiers

NCT03002194

CS0316

Details and patient eligibility

About

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

Full description

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.

Enrollment: 48 patients

Sex: Female

Ages: 18+ years old

Volunteers: 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

RF and PEMF therapy

Experimental group

Description:

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.

Treatment:

Other: Photographs

Device: Cutometer