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Study evaluating the safety and efficacy of a micro-coring device for the treatment of moderate to severe cheek wrinkles.
Up to 60 subjects who meet the Inclusion/Exclusion criteria will be treated. All subjects will be monitored for a period of 90 days after treatments.
Evaluation results will be based in the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Micro-coring of facial/neck skin with MCD | Experimental | Micro coring of facial and neck skin will be conducted in up to 2 treatments and followed 90 days post treatment with MCD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MCD | Device | Micro-coring skin removal with automated coring device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess level of wrinkle improvement using the Lemperle Wrinkle Severity Scale at 90 days post treatment | Assess level of wrinkle improvement from the baseline to 90 day post treatment an Independent Reviewer(s) using the Lemperle Wrinkle Severity Scale | 90 day post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Assess safety profile by recording of adverse events | Adverse events will be recorded throughout the study | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patricia Krantz | Cytrellis Biosystems, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laser and Skin Surgery Center of Northern California | Sacramento | California | 95816 | 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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| Miami Dermatology and Laser Institute |
| Miami |
| Florida |
| 33173 |
| United States |
| Laser and Skin Surgery Center of New York | New York | New York | 10016 | United States |
| The Practice of Brian S. Biesman, M.D | Nashville | Tennessee | 37203 | United States |
| Dr A Jay Burns Cosmetic Surgery | Dallas | Texas | 75231 | United States |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |