Change in Skin Elasticity With RF and PEMF

NCT ID: NCT03002194

Last Updated: 2020-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2017-09-29

Brief Summary

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

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.

Conditions

Skin Abnormalities

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

RF and PEMF therapy

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.

Group Type: EXPERIMENTAL

Cutometer

Intervention Type: DEVICE

Skin elasticity will be measured by a Cutometer prior to beginning treatment, week 7 and 3 months after completion of the treatment.

Photographs

Intervention Type: OTHER

Photographs will be taken prior to beginning treatment, week 7 and 3 months after completion of the treatment.

Interventions

Cutometer

Skin elasticity will be measured by a Cutometer prior to beginning treatment, week 7 and 3 months after completion of the treatment.

Intervention Type: DEVICE

Photographs

Photographs will be taken prior to beginning treatment, week 7 and 3 months after completion of the treatment.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Venus Concept

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yoni Iger, PhD

Role: STUDY_DIRECTOR

Venus Concept Ltd.

Locations

Art of Facial Surgery

North York, Ontario, Canada

Countries

Canada

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CS0316

Identifier Type: -

Identifier Source: org_study_id