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A study to evaluate the safety and effectiveness of a micro coring device for the treatment of scars.
The study subject population will consist to up to 30 subjects who meet the inclusion/exclusion criteria. All subjects will be monitored for a period of 6 months post last treatment.
An study results will be assessed on the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Micro-coring of scars with MCD | Experimental | Micro coring of acne scars and straie will be conducted in up to 3 treatments and followed 6 months post last 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 aesthetic improvement using POSAS scale 6 months post last treatment | Assessing the improvement in the aesthetic appearance of the subject based on the POSAS scale comparing baseline to 6 months post last treatment. Parameters of vascularity, pigmentation, thickness, relief, and pliability, range from 1 to 10. normal skin =1; worst scar imaginable =10. | 6 months post last treatment |
| Assess level of aesthetic improvement using ASAS scale 6 months post last treatment | Assessing the improvement in the aesthetic appearance of the subject based on the Acne Scar scale comparing baseline to 6 months post last treatment. Grades range 0-4. Clear =0; Very Mild=1; Mild= 2; Moderate= 3; Severe= 4 | 6 months post last treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Assess safety profile by recording all adverse events reported during study | Adverse events will be recorded throughout the study | 6 months post last treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami Dermatology & Laser Institute | Recruiting | Miami | Florida | 33173 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 5, 2026 | Apr 23, 2026 | 2 |
| ID | Term |
|---|---|
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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