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The purpose of this clinical study is to evaluate benefits and risks of injecting TCRM in the cheek including fine lines. The goal is to show that treatment with TCRM will result in correcting the cheek area including the fine lines at 4 weeks after last treatment (initial injection or touch up) on subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TCRM | Experimental | Treatments performed in this study include:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TCRM | Device | N=128 |
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| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate the efficacy of TCRM in the treatment of the cheek area including fine lines at 4 weeks after last injection (initial injection or touch up) using Global Aesthetic Improvement Scale (GAIS) as assessed by both subject and PI. | The Global Aesthetic Improvement (GAI) is a subjective, balanced, 5-point dynamic scale assessing cosmetic improvement. Possible scores range from "much improved", "improved", "no change", "worse", to "much worse" | 4 weeks after last injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro Médico Lajo Rosso | Madrid | Spain |
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