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This study is a prospective, up to 4 center study of the safety and efficacy of mechanical coring with skin closure of cored holes, intended for the improvement in the appearance of wrinkles of the cheeks in up to 70 subjects after two treatments.
Prospective, up to 4 center study of the safety and efficacy of mechanical coring with Tegaderm tape skin closure of cored holes to achieve improvement in the appearance of wrinkles of the cheeks. The study will evaluate the progress of up to 70 subjects after two treatments on the cheeks. Up to 70 subjects who meet inclusion/exclusion criteria will be treated. All subjects will be monitored for a period 7, 37, 60 and 120 days post treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental | All subjects will receive two coring treatments on the cheeks with the robotic coring device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venus Aime | Device | Venus Aime is a micro-coring device of the skin that can potentially help reduce moderate to severe facial wrinkles. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of correct identification of photograph sets from baseline and Day 120 | Proportion of correct identification of photograph sets from baseline and Day 120 as assessed by independent blinded evaluators. This proportion of correct identification should be greater than completely random theoretical percentage of 0.5. Statistical significance (p<0.05) should be shown using one-sided binomial test comparing to 0.5. | 4 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Assess aesthetic improvement using Global Aesthetic Improvement Scale | Overall aesthetic improvement as assessed using the Global Aesthetic Improvement Scale (GAIS) by the Investigator at Day 120 compared to baseline Very much improved (Optimal cosmetic result) = 5, Much Improved (Marked improvement from initial condition, but not completely optimal)=4, Improved (Obvious improvement in appearance from initial condition, but re-treatment is indicated)=3, No Change (The appearance is essentially the same as original condition)=2, Worse (The appearance is worse than the original condition) |
| Measure | Description | Time Frame |
|---|---|---|
| Assess subject's assessment of discomfort and pain using Visual Analogue Scale | Subjects' assessment of discomfort and pain after treatments as measured using the VAS Pain Scale immediately after treatment | 1 day |
| Assess safety profile by recording adverse events |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Matthew Gronski, PhD | Contact | 888-907-0115 | mgronski@venusconcept.com |
| Name | Affiliation | Role |
|---|---|---|
| Matthew Gronski, PhD | Venus Concept | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DeNova Research | Terminated | Chicago | Illinois | 60611 | United States | |
| Dermatology, Laser & Vein Specialists of the Carolinas, PLLC |
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| 4 Months |
| Assess subject satisfaction post-treatment using Subject Satisfaction Scale | Subject satisfaction as assessed using the Subject Satisfaction Scale (SSS) completed by subjects on Day 120. Satisfaction with the aesthetic appearance of the treatment area. Very Satisfied=4, Satisfied=3, Having No Opinion=2, Unsatisfied=1, Very Unsatisfied=0 | 4 Months |
Subjects experiencing a treatment-related adverse event (AE) in the first 120 days post treatment. |
| 4 Months |
| Recruiting |
| Charlotte |
| North Carolina |
| 28207 |
| United States |
|