Use of AAM for Correction of Age Related Volume Deficits in the Face

Completed · Not applicable

Conditions studied: Age-Related Atrophy

In brief

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.

Key facts

Study ID

NCT03652844

Run by

Musculoskeletal Transplant Foundation

People needed

24

Starts

2018-08-27

Expected to finish

2019-07-12

Last updated by the study team

2021-05-11

Who can join

Age: 30 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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
• Willingness to maintain consistent and current diet and exercise for the duration of the study
• Willingness to forego any cosmetic augmentation procedure for the duration of the study
• Willingness to be photographed for educational, medical publication and other non-commercial purposes
• Has BMI ≥18 and ≤30

You may not qualify if…

• 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
• A subject that has had, or who knowingly will have, dental work +/- 4 weeks prior to, or following AAM injection
• A subject using any systemic corticosteroid or immunosuppressive medications within 30 days prior to treatment and topical steroids on the face within 14 days prior to treatment and throughout the study
• A subject that has participated in another research study within 30 days of enrollment in this study
• A subject that is unwilling to forego any cosmetic augmentation treatment for the duration of the study
• A subject that has been treated with Botulinum Toxin below the orbital rim within 6 months of study entry.
• A subject that is unwilling to forego cosmetic facial treatments for the duration of the study
• A subject that has received Sculptra in the treatment area
• A subject that has received dermal filler in the treatment area within 2 years prior to randomization
• A subject that has previously undergone mid-face cosmetic plastic surgery, tissue grafting, or tissue augmentation with silicone, semi-permanent fillers or fat
• A subject that has previously undergone laser resurfacing, intense pulsed light treatment, chemical peel, or other ablative or non-ablative treatment within 6 months
• Subject is immunocompromised or immunosuppressed
• History of keloid formation or hypertrophic scars
• NSAID or Aspirin, other than a stable low dose aspirin regimen, within 1 week (7 days) prior to treatment
• Concomitant anticoagulant therapy, antiplatelet therapy, or history of bleeding disorders or connective tissue disorders
• A subject with recent excessive facial exposure to sunlight or artificial UV light (e.g.: use of tanning beds/booths and/or sunbathing)
• A subject with a recent history or active presence of any facial skin condition/disease that might interfere with the diagnosis or evaluation of study parameters (i.e. moderate to severe acne vulgaris, atopic dermatitis, psoriasis, rosacea, seborrheic dermatitis, excessive facial hair or coloration)
• Current participation or participation within 30 days prior to the start of this study in a drug or other investigational research study

Where it is running

• 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

Full record on ClinicalTrials.gov

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