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| ID | Type | Description | Link |
|---|---|---|---|
| AIS 700-00022 | Other Identifier | Cytrellis Biosystems, Inc. |
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This is a prospective, multi-center, pilot study evaluating effectiveness of micro-excisional skin remodeling by micro-coring skin in subjects meeting the Inclusion Criteria. Subjects will undergo bilateral treatment on the face and neck (upper and lower cheek, upper and lower lip, periocular and perioral areas, submandibular and middle neck, etc). The exact treatment area(s), choice of treatment density are left to the Investigator's discretion and subject's consent. Up to 3 treatments are allowed with a minimum of 30-day between the consecutive treatments.
The study will enroll up to 50 subjects at 6-8 investigational sites. It will evaluating effectiveness of a micro-coring device for micro-excisional skin remodeling in subjects with moderate to severe wrinkles of face and neck who meet the Inclusion/Exclusion Criteria. The choice of treatment density is at the investigator's discretion with the subject's consent. Up to 3 treatments may be performed with a minimum of 30-day interval between the consecutive treatments. Subjects will undergo bilateral micro-coring of skin on the face and upper neck, including but not limited to upper and lower cheek, upper and lower lip, periocular and perioral areas, submandibular and upper neck. The exact area(s) of treatment are left to the Investigator's discretion and subject's consent.
The subjects will be evaluated at each visit and following data will be collected:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Highthroughput Micro Coring Device | Experimental | Skin excision and removal with with Highthroughput Micro Coring device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HighThroughput Micro Coring Device | Device | Assess Safety and Efficacy for skin treatments through micro-excisional skin removal with micro-coring device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess wrinkle reduction for moderate to severe wrinkles at 90 days post treatment based on the Lemperle Wrinkle Scale | Assess wrinkle reduction in wrinkle severity score from the baseline assessed by Independent Reviewer(s) using the Lemperle Wrinkle Severity Scale. No wrinkles = 0; Just perceptible wrinkles = 1; Shallow wrinkles = 2; Moderately deep wrinkles = 3; Deep wrinkles, well-defined edges = 4; Very deep wrinkles, redundant fold = 5 | 90-day post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Assess skin laxity Improvement at 90 days post treatment | Improvement in skin laxity score from the baseline assessed by Independent Reviewer using Laxity Scale and supplemented by the Canfield Image Analyses. Global Aesthetic Improvement Scale: 3 Very Much Improved; 2 Much Improved; 1 Improved; 0 No Change; - 1 Worse; - 2 Much Worse; -3 Very Much Worse. | 90-day post-treatment |
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Inclusion Criteria:
Fitzpatrick Skin Type 1, 2, or 3 as judged by the Investigator
Two or more of the following: Facial wrinkles assessed using the Lemperle Wrinkle Assessment Scale (descriptive and pictorial)
Able to provide written informed consent, understand and willing to comply with all study related directions from investigator and follow-up visits.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patricia E Krantz, MBA | 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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| Assess skin for new collagenases | Histological changes in treated skin when compared to untreated skin consistent with new collagenases | 60, 90, 180-day post treatment |
| 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 |
| 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 |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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