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Enrolled subjects will receive one bilateral Ulthera® treatment on the knees. Up to 30 subjects will be enrolled. Study photos will be obtained prior to study treatment, immediately following study treatment, and at each post-treatment follow-up visit. Follow-up visits will occur at 90 and 180 days post-treatment.
This pilot study is a prospective, single-center clinical trial of the Ulthera® System for treating skin laxity on the knees. Global Aesthetic Improvement Scale scores and Patient Satisfaction questionnaires will be obtained at each follow-up visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ulthera® treatment of the knees | Experimental | Bilateral treatment of the knees using the Ulthera® System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ulthera® System | Device | Focused ultrasound energy delivered below the surface of the skin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in overall lifting and tightening of knee skin laxity. | Assessed based on Principal Investigator assessment using the Global Aesthetic Improvement Scale. | 90 and 180 days post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Overall improvement in skin laxity. | Determined based on a qualitative masked assessment comparing pre-treatment and post-treatment photographs; subjects' assessment based on the Subject Global Aesthetic Improvement Scale; completion of the Patient Satisfaction Questionnaire. | 90 and 180 days post-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Gold, MD | Tennessee Clinical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tennessee Clinical Research Center | Nashville | Tennessee | 37215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25065380 | Derived | Gold MH, Sensing W, Biron J. Use of micro-focused ultrasound with visualization to lift and tighten lax knee skin (1.). J Cosmet Laser Ther. 2014 Oct;16(5):225-9. doi: 10.3109/14764172.2014.949273. Epub 2014 Sep 2. |
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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 |