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All enrolled subject will receive one Ultherapy™ treatment. Study images will be obtained pre-treatment, immediate post-treatment, and at each study follow-up visit. Enrolled subjects will return for follow-up visits at 90 days, 180 days and 365 days post-treatment.
This is a prospective, single-center clinical trial to evaluate the efficacy of the Ulthera® System to provide a customized, high-density, vectored Ultherapy™ treatment to lift and tighten the skin of the face and neck. Skin laxity changes from baseline will be assessed at study follow-up visits. Global Aesthetic Improvement Scale scores and patient satisfaction questionnaires will also be obtained.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultherapy™ study treatment | Experimental | Each subject will receive a customized, high-density, vectored Ulthera System Treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ulthera System Treatment | Device | Focused ultrasound energy delivered below the surface of the skin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in overall lifting and tightening of the skin | As determined by a masked, qualitative assessment of photographs at 90 days post treatment compared to baseline. The clinical response of Ulthera treatment will be assessed by comparing photographic images taken before and after the procedure. | 90 days post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Overall aesthetic improvement | Global Aesthetic Improvement Scale scores will be obtained from the Investigator and subject, assessing improvement in skin laxity based on a comparison of post-treatment photos to pre-treatment photos. | 365 days post-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William P Werschler, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Premier Clinical Research | Spokane | Washington | 99204 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27047630 | Derived | Werschler WP, Werschler PS. Long-term Efficacy of Micro-focused Ultrasound with Visualization for Lifting and Tightening Lax Facial and Neck Skin Using a Customized Vectoring Treatment Method. J Clin Aesthet Dermatol. 2016 Feb;9(2):27-33. |
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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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| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |