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Up to 30 subjects will be enrolled. Enrolled subjects will receive an Ulthera® treatment to one side of the body, treating the lateral buttock region. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, immediately post-treatment, and at each follow-up visit.
This is a prospective, single-center, pilot clinical trial to evaluate the efficacy of the Ulthera® System to improve buttock and thigh skin laxity. Global Aesthetic Improvement Scale scores and patient satisfaction questionnaires will be obtained.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ulthera-treated subjects | Experimental | All enrolled subjects will receive one Ultherapy treatment to one side of the body in the lateral buttock region. Following study completion, subjects may elect to receive a balancing treatment to the other side of the body. |
|
| 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 |
|---|---|---|
| Overall lifting and tightening of the buttocks and thighs. | As determined by a masked, qualitative assessment of photographs at three months post-treatment compared to baseline. | 90 days post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Overall aesthetic improvement. | As determined by GAIS completed by the Investigator and subject. | 90 and 180 days post-treatment. |
| Overall subject satisfaction. | As determined by subjects' completion of a Patient Satisfaction Questionnaire. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Goldberg, MD | Skin Laser and Surgery Specialist of New York and New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skin Laser and Surgery Specialist of New York and New Jersey | New York | New York | 10022 | 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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| 90 and 180 days post-treatment |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |