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The intended use of the PicoSure and PicoSure Pro devices used in this study is to treat additional patients with the new PicoSure Pro device and collect additional data on the devices.
Subjects are to be enrolled in this clinical study if they are a healthy male or female 18 years of age or older. Up to 100 subjects will be enrolled at up to 4 study centers. Subjects will be enrolled into one of the 3 groups; Group A, Group B, or Group C.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A: Split-Face Device Only Treatment | Experimental | Subjects will receive a split face treatment with the PicoSure Pro and/or PicoSure devices using different device settings on each half of the face. |
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| Group B: Split-Face Treatment with Cosmeceuticals | Experimental | Subjects will receive a full face treatment with the PicoSure Pro or PicoSure device and will use topical cosmeceuticals on only half of their face. |
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| Group C: Device Only Treatment | Experimental | Subjects will receive treatments with the PicoSure Pro or PicoSure device on multiple areas of the body such as the face, décolletage, back, legs, arms, and hands. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PicoSure Pro Device | Device | This device will be used for up to 4 treatments over the designated areas. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Grading of Pre-Treatment vs. Follow Up Images | The investigator will grade the improvement they noticed between the baseline image and the follow up image based on the Global Aesthetic Improvement Scale (GAIS), which ranges from 1-5 as follows: Very Much Improved (1), Much Improved (2), Improved (3), No Change (4), Worse (5). | 30 day follow up |
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Inclusion Criteria:
Exclusion Criteria:
Cautionary Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Civiok | Director of Clinical Research | Study Director |
| Sean Doherty | Cynosure, Inc. | Principal Investigator |
| Emil Tanghetti | Center for Dermatology and Laser Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Dermatology and Laser Surgery | Sacramento | California | 95819 | United States | ||
| Cynosure, Inc. |
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| ID | Term |
|---|---|
| D000068937 | Cosmeceuticals |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
| D003358 | Cosmetics |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
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Randomization is not used for determining which arm subjects will participate in, however, it will be used to determine which side of the treatment area will receive which treatment regimen (if in a group receiving split-face treatments).
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| PicoSure Device | Device | This device will be used for up to 4 treatments over the designated areas. |
|
| Topical Cosmeceuticals | Drug | Topical cosmeceuticals, such as a hydrating serum or cream, will be applied on the designated area. |
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| Westford |
| Massachusetts |
| 01886 |
| United States |