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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
24
Subcutaneous injection procedure
Aesthetic Eyelid Plastic Surgery
Boca Raton, Florida, United States
Tennessee Clinical Research Center
Nashville, Tennessee, United States
Dallas Plastic Surgery Institute
Dallas, Texas, United States
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.
Time frame: 24 weeks
Three-D facial photography (Canfield) with computation of volume changes at 24 weeks compared to pre-treatment.
Time frame: 24 weeks
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.
Time frame: 24 weeks
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.
Time frame: 24 weeks
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