Evaluation of Safety and Efficacy of Using Venus Freeze™ (MP)2 V2 System for Wrinkles Rhytides and Cellulite Treatment

Venus Concept

Status

Completed

Conditions

Wrinkled Structure

Circumference Reduction

Treatments

Device: Venus Freeze (MP2 V2 System

Study type

Interventional

Funder types

Industry

Identifiers

NCT01234259

VN-WR- 01

Details and patient eligibility

About

Skin aging is a multifactorial process involving the 3 layers of the skin: Epidermis, dermis and hypodermis.

Radio-frequency (RF) devices have been used for many years for a variety of surgical applications. The energy delivery systems of these established monopolar devices used a 'conductive coupling' delivery system in which energy is concentrated at the periphery of the electrode.

Venus Concept has developed the Venus Freeze (MP)2 V2 system for wrinkles, rhytides and temporary cellulite and circumference reduction treatments. While treating wrinkles rhytides and cellulite, the treatments creates enough thermal effect to induce collagen remodeling with no ablative thermal damage in the epidermis or dermis.

Enrollment

60 patients

Sex

All

Ages

30+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy males and females age 30 and up
Subjects with Fitzpatrick 4 to 9 degrees of elastosis
Subject able to comprehend and give informed consent for participation in this study
Subject must commit to all treatments and follow-up visits
Subject must sign the Informed Consent Form

Exclusion criteria

Subjects with implanted pacemakers, arrhythmias or any other severe known heart disorder
Subjects with any implantable metal device in the treatment area
Subjects on any medication that would affect the characteristic of the skin (medical or hormonal), such as "Accutane", within the past 6 months or photosensitizing medications
Subjects that have had any other invasive or non invasive method of skin therapy or hair removal performed in the past 9 months (in the treated area) Subjects who are scheduled or planned for any other invasive or non invasive method of skin therapy or hair removal in the treated area at the period of the study
Subjects who have any form of malignant skin cancer on the treatment area
Subjects with history of keloid formations or hypertrophic scarring
Pregnant or lactating Subjects
Subjects with Epilepsy or severe migraines
Subjects with permanent makeup/ tattoo/ body piercing (in the treated area)
Subjects with any Infection / abscess / dermatitis/ pains in treatment target area.
Subjects who suffer from autoimmune disorders or diabetes
Subjects with clotting disorders
Subjects are suffering from psychiatric disorders and treated with psychiatric medications.
Subject is suffering extreme general weakness.
Subject objects to the study protocol
Concurrent participation in any other clinical study
Physician objection