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Up to 10 subjects will be enrolled. All subjects will receive an increased density UltherapyTM treatment at dual depth. Treatments will be provided to the lower 2/3 of the face and neck. Follow-up visits will occur at 90 and 180 days post-treatment. Study images will be obtained pre-treatment, 30-60 min post-treatment, and at each follow-up visit.
This is a prospective, single-site, non-randomized clinical trial efficacy of an additional Ultherapy™ treatment for subjects who were minimal or non-responders at Day 90 in a previous Ulthera clinical trial. Global Aesthetic Improvement Scale scores and patient satisfaction questionnaires will be obtained.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ulthera treatment group | Experimental | All subjects will receive an 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 lower face and neck skin laxity | Efficacy will be assessed using the 90-day images compared to baseline | 90 days post-treatment |
| Cervicomental angle | Efficacy will be assessed using the 90-day images compared to baseline. | 90 days post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Overall aesthetic improvement | Principal Investigator and subject will complete a Global Aesthetic Improvement Scale at 90 days post-treatment. | 90 days post-treatment |
| Patient satisfaction | Subjects will complete a Patient Satisfaction Questionnaire at 90 days post-treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Steven H Dayan, MD, FACS | DeNova Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DeNova Research | Chicago | Illinois | 60611 | 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 days post-treatment |
| Pain Assessment | Subject assessment of pain will be obtained using a 10-point validated Numeric Rating Scale following completion of each depth of treatment. | Treatment visit |
| Patient Satisfaction | Subjects will complete a Patient Satisfaction Questionnaire at 180 days post-treatment. | 180 days post-treatment |
| Overall aesthetic improvement | Principal Investigator and subject will complete a Global Aesthetic Improvement Scale at 180 days post-treatment. | 180 days post-treatment |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |