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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | Device: Venus Freeze (MP)2 V2 system |
|
| control group: | Sham Comparator | Sham comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venus Freeze (MP2 V2 System | Device | Facial wrinkles and temporary cellulite and circumference reduction treatments |
|
| 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. | 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 |
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eli Sprecher, Prof. | Tel-Aviv Sourasky medical Centre, Israel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sourasky medical Centre | Tel Aviv | 64239 | Israel |
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| ID | Term |
|---|---|
| D000071697 | Cellulite |
| ID | Term |
|---|---|
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 5 months |