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The purpose of this study is to use the 1440nm Wavelength laser along with the hand piece to provide clinical outcome data for treatment of the mandibular and submandibular areas specifically for skin tightening and laser lipolysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1440 nm wavelength laser with hand piece | Experimental | To assess the effectiveness of the 1440 nm wavelength laser with handpiece for skin tightening and laser lipolysis for the mandibular and sub-mandibular areas |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1440 nm wavelength laser with handpiece (Cynosure) | Device | To assess the effectiveness of device in skin tightening and laser lipolysis in the mandibular and sub-mandibular areas. |
| Measure | Description | Time Frame |
|---|---|---|
| Photographic Evaluation | Photos will be evaluated by the investigator comparing time baseline and 3 month photos using the global aesthetic improvement scale | 3 months post last treatment |
| Photographic Evaluation | Photographs will be evaluated and compared by investigator for baseline and 3 month images using the Cervicomental Angle Scale | 3 months post last treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events | Side effects and events will be recorded | up to 3 months post last treatment |
| Photographic Evaluation | Photos will be evaluated by the investigator comparing time baseline and 1 week photos using the global aesthetic improvement scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patricia Krantz | Cynosure, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cosmetique - Dermatology, Laser & Plastic Surgery LLP | Greenvale | New York | 11548 | United States |
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Even though this study has recruited slightly more than 10 participants, it is a feasibility study, designed to test the prototype rather than measuring health outcomes. It is to confirm the operating specifications before beginning a full clinical trial.
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| 1 week post treatment |
| Photographic Evaluation | Photographs will be evaluated and compared by investigator for baseline and 1 week images using the Cervicomental Angle Scale | 1 week post treatment |