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The purpose of this study is to evaluate Allograft Adipose Matrix (AAM) in the face of people with age-related volume deficit - fat loss. AAM is a tissue used to correct fat loss. Participation in this study requires injections for placing AAM in the bilateral pre-jowl and malar areas of the face. The research will tell whether AAM is effective in maintaining mid-face fullness and whether the appearance of the skin improves after injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allograft Adipose Matrix (AAM) 1.0 | Active Comparator |
| |
| Allograft Adipose Matrix (AAM) Diluted | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AAM | Procedure | Subcutaneous injection procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Volume change for the treated areas using the validated 4 point MEDICIS Mid-Face Volume Scale Assessment (MMVSA) at 24 weeks post-treatment compared to pre-treatment | MMVSA measures facial volume deficit, ranging from 1 (fairly full midface) to 4 (substantial loss of fullness in the midface area). Lower values represent a better outcome. | 24 weeks |
| Three-D facial photography (Canfield) with computation of volume changes at 24 weeks compared to pre-treatment. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of effectiveness when the average of the Evaluating Investigators' live assessments of the MMVSA scale will return to, or be worse than, the pre-treatment level over 24 weeks post-treatment. | MMVSA measures facial volume deficit, ranging from 1 (fairly full midface) to 4 (substantial loss of fullness in the midface area). Lower values represent a better outcome. | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aesthetic Eyelid Plastic Surgery | Boca Raton | Florida | 33431 | United States | ||
| Tennessee Clinical Research Center |
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Randomized cohorts
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| Volume change assessments using the Global Aesthetic Improvement Scale (GAIS) at 24 weeks post-treatment compared to pre-treatment | GAIS rates improvement in appearance. Scores range from 0 (worse) to 4 (very much improved). Higher values represent a better outcome. | 24 weeks |
| Nashville |
| Tennessee |
| 37215 |
| United States |
| Dallas Plastic Surgery Institute | Dallas | Texas | 75231 | United States |