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

NCT ID: NCT01234259

Last Updated: 2020-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2014-09-30

Brief Summary

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.

Conditions

Wrinkled Structure; Circumference Reduction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study group

Device: Venus Freeze (MP)2 V2 system

Group Type: EXPERIMENTAL

Venus Freeze (MP2 V2 System

Intervention Type: DEVICE

Facial wrinkles and temporary cellulite and circumference reduction treatments

control group:

Sham comparator

Group Type: SHAM_COMPARATOR

Venus Freeze (MP2 V2 System

Intervention Type: DEVICE

Facial wrinkles and temporary cellulite and circumference reduction treatments

Interventions

Venus Freeze (MP2 V2 System

Facial wrinkles and temporary cellulite and circumference reduction treatments

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Venus Concept

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eli Sprecher, Prof.

Role: PRINCIPAL_INVESTIGATOR

Tel-Aviv Sourasky medical Centre, Israel

Locations

Sourasky medical Centre

Tel Aviv, , Israel

Countries

Israel

Other Identifiers

VN-WR- 01

Identifier Type: -

Identifier Source: org_study_id