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This study will evaluate the clinical safety and the performance of the BTL-785F system equipped with the BTL-785-7 applicator for non-invasive treatment of facial wrinkles. The study is a multicenter single-arm, open-label, interventional study.
This study will evaluate the clinical safety and the performance of the BTL-785F system equipped with the BTL-785-7 applicator 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.
At the baseline visit health status will be assessed and, if needed, additional tests will be performed. Inclusion and exclusion criteria will be verified and informed consent will be signed.
The treatment administration phase consists of four (4) treatment visits, delivered 5-10 days apart.
Safety measures will include documentation of adverse events (AE) including the subject's experience of pain or discomfort after the procedure. Occurrence of AE's will be checked immediately after the first treatment visit, prior/post to the every other procedure and at the follow-ups.
Subjects will undergo two follow-up visits scheduled at 1 month and 3 months after the final treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BTL-785-7 Treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BTL-785-7 | Device | Treatment with the BTL-785-7 applicator to the BTL-785F system. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Noninvasive Treatment Of Wrinkles | Assess reduction of wrinkle severity according to the Fitzpatrick Wrinkle and Elastosis Scale. Baseline and post-treatment photographs will be evaluated. A statistically significant reduction of at least 1.0 score in the average score of Fitzpatrick Wrinkle and Elastosis Scale should be achieved. | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yael Halaas M.D. | New York | New York | 10022 | United States | ||
| Gentile Facial Plastic Surgery & Aesthetic Laser Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37379470 | Derived | Gentile R, Halaas Y. Novel Approach to Facial Rejuvenation by Treating Cutaneous and Soft Tissue for Wrinkles Reduction: First Experience from Multicenter Clinical Trial. Facial Plast Surg Aesthet Med. 2024 Jan-Feb;26(1):1-6. doi: 10.1089/fpsam.2023.0015. Epub 2023 Jun 28. |
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| ID | Term |
|---|---|
| D003483 | Cutis Laxa |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
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| Youngstown |
| Ohio |
| 44512 |
| United States |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |