- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01234259
Evaluation of Safety and Efficacy of Using Venus Freeze™ (MP)2 V2 System for Wrinkles Rhytides and Cellulite Treatment
Evaluation of Safety and Efficacy of Using Venus Freeze™ (MP)2 V2 System for Wrinkles Rhytides and Cellulite Treatment - a Pilot Study
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Tel-Aviv, Israel, 64239
- Sourasky Medical Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Study group
Device: Venus Freeze (MP)2 V2 system
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Facial wrinkles and temporary cellulite and circumference reduction treatments
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Sham Comparator: control group:
Sham comparator
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Facial wrinkles and temporary cellulite and circumference reduction treatments
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
5 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
5 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Eli Sprecher, Prof., Tel-Aviv Sourasky medical Centre, Israel
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- VN-WR- 01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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