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

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.

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Key information

Conditions

Wrinkled Structure Cellulite Circumference Reduction Pathological Conditions, Signs and Symptoms Signs and Symptoms Skin Manifestations

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sourasky medical Centre

Tel Aviv, 64239, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Venus Freeze (MP2 V2 System

Device

Facial wrinkles and temporary cellulite and circumference reduction treatments

Primary outcomes

To evaluate the efficacy of the Venus system for wrinkles rhytides and temporary cellulite and circumference reduction treatment. Efficacy evaluation will include RF, Magnetic Pulse Field and vacuum technology.

Time frame: 5 months

Efficacy will be established by skin improvement as a result of the treatment by validated scales. Results will be compared to control group results. The pre - and post-treatment photographs will be compared and assessed by three independent dermatologists.

Secondary outcomes

To evaluate the safety of the Venus Freeze (MP)2 V2 system for wrinkles, rhytides, temporary cellulite and circumference reduction. Safety evaluation will include RF, Magnetic Pulse Field and vacuum technology.

Time frame: 5 months

Safety parameters will include adverse events (signs of pain; edema; burn; localized infection; skin pigmentation & texture alterations) occurring as a direct result of the treatment and complaints up to last follow up visit.

Sponsors and collaborators

Lead sponsor

Venus Concept

Industry

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2014
Study completion: 2014
First posted: Nov 4, 2010
Registry last updated: Apr 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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