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Up to 20 subjects will be enrolled. Subjects will receive treatment of the décolleté using the Ulthera® System. Subjects will be return for follow-up visits at 90 and 180 days post-treatment. The study will evaluate the effectiveness of the Ulthera® System to lift and tighten the skin of the décolleté region.
This is a prospective, single-center study. Baseline Fabi/Bolton 5-Point Chest Wrinkle scale scores and chest measurements will be assessed prior to study treatment. Study images will be obtained pre-treatment, immediate post-treatment, and at each follow-up visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultherapy™ treatment on the décolleté | Experimental | All enrolled subjects will receive the study treatment. |
|
| 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 skin | Lifting and tightening of décolleté skin as determined by a masked, qualitative assessment of photographs at 90 days posttreatment compared to baseline. | 90 days post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Skin Laxity of the Décolleté | The amount of skin laxity will be assessed using the Fabi/Bolton 5-Point Chest Wrinkle Scale. Skin laxity will be assessed at each follow-up visit compared to baseline. | 90 and 180 days post-treatment |
| Bilateral chest measurements |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Goldman, MD | Goldman, Butterwick, Fitzpatrick & Groff of Dermatology Cosmetic Laser | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Goldman, Butterwick, Fitzpatrick & Groff of Dermatology Cosmetic Laser | San Diego | California | 92121 | United States |
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Measurements from mid-clavicle to nipple obtained at each follow-up visit compared to baseline to assess for lifting and tightening of skin. |
| 90 and 180 days post-treatment |
| Overall aesthetic improvement | Based on Global Aesthetic Improvement Scale (GAIS) scores. | 90 and 180 days post-treatment |
| Patient satisfaction | Subject-completed questionnaire. | 90 and 180 days post-treatment |