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Single center, single-arm, prospective, open Label with Before & After Study Design.
Single center, single-arm, prospective, open Label with Before & After Study Design. The control group will be the subjects before the triLiftâ„¢ treatment protocol and the experimental group will consist of the same subjects after completion of the triLiftâ„¢ treatment protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trilift system treatment arm | Other | Single arm with Before & After photos, triLift treatment protocol study design. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| triLift system | Device | To evaluate the efficacy of the triLiftâ„¢ treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Global Aesthetic Improvement scale (GAI) | The Global Aesthetic Improvement scale (GAI) - Success is defined as an improvement of at least 1 point on the GAI scale assessed by the investigator, at the end of the treatment protocol as compared to baseline. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| 3D images | Measuring facial lifting using 3D imaging and analysis algorithm from Quantificare before and after the treatment protocol | 4 months |
| Comfort assessment | Subject assessment of pain and discomfort associated with treatments using a Pain Visual Analogue Scale (VAS), where 0 is "no pain" and 10 is "worst pain possible |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fiona Kerr | Contact | 212-249-9440 | nurses@nylaserskincare.com |
| Name | Affiliation | Role |
|---|---|---|
| Arielle Kauvar, MD | New York Laser & Skin Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NY Laser Skin Care | Recruiting | New York | New York | 10028 | 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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| 3 months |
| Subject level of Satisfaction | Subject satisfaction will be assessed using a 5 level satisfaction questionnaire. | 4 months |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |