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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Venus Concept
ClinicalTrials.gov Identifier:
NCT01234259
First received: November 3, 2010
Last updated: June 3, 2015
Last verified: June 2015
  Purpose

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.


Condition Intervention
Wrinkled Structure
Circumference Reduction
Device: Venus Freeze (MP2 V2 System

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Safety and Efficacy of Using Venus Freeze™ (MP)2 V2 System for Wrinkles Rhytides and Cellulite Treatment - a Pilot Study

Further study details as provided by Venus Concept:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 60
Study Start Date: December 2010
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study group
Device: Venus Freeze (MP)2 V2 system
Device: Venus Freeze (MP2 V2 System
Facial wrinkles and temporary cellulite and circumference reduction treatments
Sham Comparator: control group:
Sham comparator
Device: Venus Freeze (MP2 V2 System
Facial wrinkles and temporary cellulite and circumference reduction treatments

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01234259

Locations
Israel
Sourasky medical Centre
Tel-Aviv, Israel, 64239
Sponsors and Collaborators
Venus Concept
Investigators
Principal Investigator: Eli Sprecher, Prof. Tel-Aviv Sourasky medical Centre, Israel
  More Information

No publications provided

Responsible Party: Venus Concept
ClinicalTrials.gov Identifier: NCT01234259     History of Changes
Other Study ID Numbers: VN-WR- 01
Study First Received: November 3, 2010
Last Updated: June 3, 2015
Health Authority: Israel: Ethics Commission

Keywords provided by Venus Concept:
Wrinkles
rhytides
Cellulite
circumference reduction

ClinicalTrials.gov processed this record on July 01, 2015