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 range
30 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Men or women, 30-70 years of age
. Has overall mid-facial volume deficit of Grade 3 or 4 on Medicis Midface Volume Scale (MMVS)
. Willingness and ability to provide written informed consent
. Has not had AAM injected above the neck
. Ability to understand and comply with the requirements of the study
. Negative urine pregnancy test results at the time of study entry (if applicable).
. Willingness to stay on consistent and current skin care regimen for the duration of the study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.
. Willingness to maintain consistent and current diet and exercise for the duration of the study
Exclusion criteria
. A subject with any uncontrolled systemic disease.
. A subject in whom therapy for a systemic disease is not yet stabilized will not be considered for entry into the study.
. 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.
. Women that are pregnant, nursing, or planning a pregnancy during the duration of the study
. A subject that has had AAM injected above the neck
. A subject unwilling to be photographed for educational, medical publication and other non-commercial purposes
. A subject with a history of diabetes
. A subject with known hypersensitivity to any of the components of AAM