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This study will evaluate the clinical safety and the performance of the BTL-785F system for non-invasive treatment of facial wrinkles. The study is a multicenter single-arm, open-label, interventional study. The subjects will be enrolled and assigned into one experimental study arm. The subjects will be required to complete four (4) treatment visits and two follow-up visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reduction of wrinkles | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BTL-785F | Device | Radiofrequency |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess reduction of wrinkle severity according to the Fitzpatrick Wrinkle and Elastosis Scale | The primary efficacy outcome measure is a statistically significant reduction of at least 1.0 score in the average score of Fitzpatrick Wrinkle and Elastosis Scale score according to at least 2 out of 3 blinded dermatologists at 3-months follow-up compared to baseline. | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for specialized medical care - Individual dermatological practice Dr. Mariya Genova | Plovdiv | 4000 | Bulgaria |
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