| Eligibility |
Inclusion Criteria:
1. Men or women, 30-70 years of age
2. Has overall mid-facial volume deficit of Grade 3 or 4 on Medicis Midface Volume Scale
(MMVS)
3. Willingness and ability to provide written informed consent
4. Has not had AAM injected above the neck
5. Ability to understand and comply with the requirements of the study
6. Negative urine pregnancy test results at the time of study entry (if applicable).
7. Willingness to stay on consistent and current skin care regimen for the duration of
the study
8. Willingness to maintain consistent and current diet and exercise for the duration of
the study
9. Willingness to forego any cosmetic augmentation procedure for the duration of the
study
10. Willingness to be photographed for educational, medical publication and other
non-commercial purposes
11. Has BMI =18 and =30
Exclusion Criteria:
1. A subject with any uncontrolled systemic disease.
2. A subject in whom therapy for a systemic disease is not yet stabilized will not be
considered for entry into the study.
3. 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.
4. Women that are pregnant, nursing, or planning a pregnancy during the duration of the
study
5. A subject that has had AAM injected above the neck
6. A subject unwilling to be photographed for educational, medical publication and other
non-commercial purposes
7. A subject with a history of diabetes
8. A subject with known hypersensitivity to any of the components of AAM
9. A subject that has had, or who knowingly will have, dental work +/- 4 weeks prior to,
or following AAM injection
10. 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
11. A subject that has participated in another research study within 30 days of enrollment
in this study
12. A subject that is unwilling to forego any cosmetic augmentation treatment for the
duration of the study
13. A subject that has been treated with Botulinum Toxin below the orbital rim within 6
months of study entry.
14. A subject that is unwilling to forego cosmetic facial treatments for the duration of
the study
15. A subject that has received Sculptra in the treatment area
16. A subject that has received dermal filler in the treatment area within 2 years prior
to randomization
17. A subject that has previously undergone mid-face cosmetic plastic surgery, tissue
grafting, or tissue augmentation with silicone, semi-permanent fillers or fat
18. A subject that has previously undergone laser resurfacing, intense pulsed light
treatment, chemical peel, or other ablative or non-ablative treatment within 6 months
19. Subject is immunocompromised or immunosuppressed
20. History of keloid formation or hypertrophic scars
21. NSAID or Aspirin, other than a stable low dose aspirin regimen, within 1 week (7 days)
prior to treatment
22. Concomitant anticoagulant therapy, antiplatelet therapy, or history of bleeding
disorders or connective tissue disorders
23. A subject with recent excessive facial exposure to sunlight or artificial UV light
(e.g.: use of tanning beds/booths and/or sunbathing)
24. 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)
25. Current participation or participation within 30 days prior to the start of this study
in a drug or other investigational research study
26. A subject not deemed to be enrolled at the discretion of the surgeon investigator
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