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To evaluate the wrinkle-reducing effects of 3.25-MHz radiofrequency (RF) energy delivered in 4 weekly applications to human periorbital skin area by grating pre- and 90-days post treatment photographs on the Fitzpatrick Wrinkle Severity Scale (FWSS) by three blinded evaluators.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XP200 device RF treatments | Experimental | Every subject in the study will undergo 4 treatments and will be followed up for 6 months with photoraphic 3 evaluations: before treatment, 3 and 6 months follow-up. Photographs will be scored on a Fitzpatrick scale by 3 blinded evaluators. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RF XP200 | Device | Four weekly non-invasive periorbital wrinkles treatment with RF XP200 device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in wrinkles appearance | One point or greater improvement in periorbital wrinkle score on a Fitzpatrick scale 3 months after last treatment as determined by at least 2 out of 3 blinded photographs evaluators | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Georgi Petkov | BTL Industries Ltd. | Study Director |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 3, 2015 | |
| Reset | Feb 17, 2015 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 3, 2015 | Feb 17, 2015 |
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| XP200 RF device | Device | 4 RF treatments of periorbital region on one side of the face |
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