Wrinkled StructureNCT01234259
Evaluation of Safety and Efficacy of Using Venus Freeze™ (MP)2 V2 System for Wrinkles Rhytides and Cellulite Treatment
A study testing Venus Freeze (MP2 V2 System in people with Wrinkled Structure and Circumference Reduction, run by Venus Concept at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Wrinkled Structure, Circumference Reduction
- What is being tested?
- Venus Freeze (MP2 V2 System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2010to Sep 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Wrinkled Structure, Circumference Reduction
- Being tested
- Venus Freeze (MP2 V2 System
- Keywords
- Wrinkles, rhytides, Cellulite, circumference reduction
- Medical subject headings
- Cellulite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venus Freeze (MP2 V2 SystemDevice
Facial wrinkles and temporary cellulite and circumference reduction treatments
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Device: Venus Freeze (MP)2 V2 system Receives: Device: Venus Freeze (MP2 V2 System |
| control group: | Sham comparator | Sham comparator Receives: Device: Venus Freeze (MP2 V2 System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 months
Secondary outcomes (1)
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.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2010 (estimated)
- Study startDec 2010
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wrinkled StructureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Venus Concept
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eli Sprecher, Prof., Principal investigator, Tel-Aviv Sourasky medical Centre, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01234259
- Sponsor's protocol ID
- VN-WR- 01
- Status last verified
- Apr 2020
- First submitted
- 3 Nov 2010
- Last updated
- 16 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Efficacy of Using Venus Freeze™ (MP)2 V2 System for Wrinkles Rhytides and Cellulite Treatment - a Pilot Study
- ClinicalTrials.gov ID
- NCT01234259
- Acronym / sponsor ID
- VN-WR- 01
- Conditions
- Wrinkled Structure, Circumference Reduction
- Keywords
- Wrinkles, rhytides, Cellulite, circumference reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Venus ConceptIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 4 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Device: Venus Freeze (MP2 V2 SystemDevice: Venus Freeze (MP)2 V2 system |
| control group: | Sham comparator | Device: Venus Freeze (MP2 V2 SystemSham comparator |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Venus Freeze (MP2 V2 SystemFacial wrinkles and temporary cellulite and circumference reduction treatments | Device | Study group, control group: |
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2020.
Related trials for Wrinkled Structure
Recruiting
Effect of Single Facial Acupuncture on Dermal Structure and Appearance Satisfaction
Facial Aging, Wrinkles
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eli Sprecher, Prof. principal investigator
Tel-Aviv Sourasky medical Centre, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Venus Freeze (MP2 V2 System in people with Wrinkled Structure and Circumference Reduction, run by Venus Concept at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2020.