search
Back to results

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

Primary Purpose

Wrinkled Structure, Circumference Reduction

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Venus Freeze (MP2 V2 System
Sponsored by
Venus Concept
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Wrinkled Structure focused on measuring Wrinkles, rhytides, Cellulite, circumference reduction

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Sourasky medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Study group

control group:

Arm Description

Device: Venus Freeze (MP)2 V2 system

Sham comparator

Outcomes

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.
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.
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.

Full Information

First Posted
November 3, 2010
Last Updated
April 15, 2020
Sponsor
Venus Concept
search

1. Study Identification

Unique Protocol Identification Number
NCT01234259
Brief Title
Evaluation of Safety and Efficacy of Using Venus Freeze™ (MP)2 V2 System for Wrinkles Rhytides and Cellulite 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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Venus Concept

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wrinkled Structure, Circumference Reduction
Keywords
Wrinkles, rhytides, Cellulite, circumference reduction

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study group
Arm Type
Experimental
Arm Description
Device: Venus Freeze (MP)2 V2 system
Arm Title
control group:
Arm Type
Sham Comparator
Arm Description
Sham comparator
Intervention Type
Device
Intervention Name(s)
Venus Freeze (MP2 V2 System
Intervention Description
Facial wrinkles and temporary cellulite and circumference reduction treatments
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
5 months
Secondary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eli Sprecher, Prof.
Organizational Affiliation
Tel-Aviv Sourasky medical Centre, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sourasky medical Centre
City
Tel-Aviv
ZIP/Postal Code
64239
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs