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This is an open-label, single-center study. Subjects in this study will receive up to four (4) facial treatments at 4-6 (±1) weeks interval, with the VBeam Prima device according to the study protocol. Subjects will return for follow-up (FU) visits at the clinic at 1 and 3 months following the last treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VBeam Prima | Device | Up to four treatments will be performed every 4-6 (±1) weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Global Improvement Scale | Overall improvement using Global Improvement Scale (0=no response; 4=excellent response). | 1 or 3 months post last treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Wrinkle and Elastosis Score | Improvement using Fitzpatrick Wrinkle Class and Elastosis Score | Pre Tx.4, 1 month and 3 months post final treatment |
| Treatment discomfort based on NRS Scale | Evaluate treatment discomfort based on NRS Scale as reported by study subjects |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gilly Munavalli, MD | Contact | (704) 375-6766 | info@carolinaskin.com | |
| Cindy Tucker, RN-C | Contact | (704) 375-6766 | info@carolinaskin.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dermatology, Laser & Vein Specialists of the Carolinas | Recruiting | Charlotte | North Carolina | 28207 | United States |
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| Immediately post treatment |