Use of AAM for Correction of Age Related Volume Deficits in the Face (NCT03652844) | Clinical Trial Compass
CompletedNot Applicable
Use of AAM for Correction of Age Related Volume Deficits in the Face
United States24 participantsStarted 2018-08-27
Plain-language summary
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.
Who can participate
Age range30 Years ā 70 Years
SexALL
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Inclusion criteria
ā. Men or women, 30-70 years of age
ā. Has overall mid-facial volume deficit of Grade 3 or 4 on Medicis Midface Volume Scale (MMVS)
ā. Willingness and ability to provide written informed consent
ā. Has not had AAM injected above the neck
ā. Ability to understand and comply with the requirements of the study
ā. Negative urine pregnancy test results at the time of study entry (if applicable).
ā. Willingness to stay on consistent and current skin care regimen for the duration of the study
ā. Willingness to maintain consistent and current diet and exercise for the duration of the study
Exclusion criteria
ā. A subject with any uncontrolled systemic disease.
ā. A subject in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study.
ā. A subject with a significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would preclude enrollment into the study.
ā. Women that are pregnant, nursing, or planning a pregnancy during the duration of the study
ā
What they're measuring
1
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
Timeframe: 24 weeks
2
Three-D facial photography (Canfield) with computation of volume changes at 24 weeks compared to pre-treatment.