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Open-label, non-randomized 2 arms prospective, multi-center, self-controlled clinical study with masked evaluation.
This study is a two-arm study. Eligible patients will receive 2-4 face and/or neck and/or submental or "off the face" (abdomen, or arms, or thighs, or Décolleté) treatments (per PI discretion, 2-12 weeks apart) using the Sofwave System. In arm 1, each investigational site would treat the full face and/or neck and/or submental zones including 1. -The forehead and temples (left and right including the peri orbital zone) to lift the eyebrows 2. The cheeks (left and right including perioral zone and nasolabial folds) 3. Submental and sides of the neck (left and right) to lift lax skin. In arm 2, each site would treat "off the face" areas: abdomen, or arms or thighs or Décolleté. Each patient could be assigned to both arms. Treatment may be administered after the enrollment and screening at the first visit or it may occur at a later date following the enrollment and screening activities based on site scheduling availabilities. All patients will return to the clinic for one follow up visitat3 months ± 2 weeks post last treatment (FU1) and a second optional visit at 2. 6 months ± 2 weeks post last treatment (FU2; optional). Each treatment visit will also serve as a follow up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| face and/or neck and/or submental zones | Experimental | the full face and/or neck and/or submental zones including 1. -The forehead and temples (left and right including the peri orbital zone) to lift the eyebrows 2. The cheeks (left and right including perioral zone and nasolabial folds) 3. Submental and sides of the neck |
|
| "off the face" areas | Experimental | "off the face" areas: abdomen, or arms or thighs or Décolleté. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sofwave | Device | The Sofwave System, comprised of an applicator and a console, generates high intensity, non-focused ultrasonic energy which can be delivered percutaneously to tissues. |
| Measure | Description | Time Frame |
|---|---|---|
| Improvements in lifting of lax tissue | as assessed by independent masked evaluators of pre and post treatment images. | 3 and 6 months post last treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ruthie Amir, MD | Sofwave | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SLSS, a Division of Schweiger Dermatology Group Research Office | Hackensack | New Jersey | 07601 | United States | ||
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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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| The Practice of Brian S. Biesman, MD |
| Nashville |
| Tennessee |
| 37203 |
| United States |
| Tennessee Clinical Research Center | Nashville | Tennessee | 37215 | United States |
| McDaniel Institute of Aging Research | Virginia Beach | Virginia | 23462 | United States |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |