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A retrospective study to evaluate the Ulthera® System for its potential interaction with toxins and fillers. Up to 500 subjects will be enrolled.
This is a retrospective, multi-site study involving chart reviews of subjects who have received an Ultherapy treatment along with Radiesse®, Xeomin®, and/or Belotero® Balance within six months apart in the face and/or neck areas. Enrolled subjects will have received an Ultherapy treatment along with botulinum toxin A and/or filler treatment(s) within the last two years and with filler and toxin treatment occurring within 6 months before or after Ultherapy.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultherapy | Device | Focused ultrasound energy delivered below the surface of the skin. |
| |
| Incobotulinumtoxin A | Drug | An injectable medicine used to temporarily improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults. |
| |
| Radiesse | Device | An injectable dermal filler that temporarily adds volume to help smooth moderate to severe facial wrinkles and folds, such as nasolabial folds (the creases that extend from the corner of the nose to the corner of the mouth). |
| |
| Belotero Balance | Device | An injectable dermal filler to temporarily smooth out and fill in moderate-to-severe nasolabial folds (the folds or wrinkles that go from the side of the nose to the corner of the mouth). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | An assessment of adverse events through chart review will evaluate the safety of combination treatments of Ultherapy with toxins/fillers. | Within 6 months before or after Ultherapy |
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Inclusion Criteria:
Exclusion Criteria:
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Adults between 25 and 70 years of age who have received an Ultherapy treatment and toxin/filler within the last two years within six months apart and meet the inclusion/exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Liss Misell, PhD | Ulthera, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aesthetic Plastic Surgical Institute | Laguna Beach | California | 92651 | United States | ||
| Dermatology Cosmetic Laser Medical Associates of La Jolla |
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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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| ID | Term |
|---|---|
| C545476 | incobotulinumtoxinA |
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| San Diego |
| California |
| 92121 |
| United States |
| Skin Research Institute | Coral Gables | Florida | 33146 | United States |
| Maryland Laser Skin and Vein Institute | Hunt Valley | Maryland | 21030 | United States |
| Premier Clinical Research | Spokane | Washington | 99202 | United States |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |