Use of AAM for Correction of Age Related Volume Deficits in the Face
Not Applicable
Completed
- Conditions
- Age-Related Atrophy
- Interventions
- Procedure: AAM
- Registration Number
- NCT03652844
- Lead Sponsor
- Musculoskeletal Transplant Foundation
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
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
- 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
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
- 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
- A subject not deemed to be enrolled at the discretion of the surgeon investigator
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Allograft Adipose Matrix (AAM) Diluted AAM - Allograft Adipose Matrix (AAM) 1.0 AAM -
- Primary Outcome Measures
Name Time Method 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 24 weeks 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.
Three-D facial photography (Canfield) with computation of volume changes at 24 weeks compared to pre-treatment. 24 weeks
- Secondary Outcome Measures
Name Time Method Volume change assessments using the Global Aesthetic Improvement Scale (GAIS) at 24 weeks post-treatment compared to pre-treatment 24 weeks GAIS rates improvement in appearance. Scores range from 0 (worse) to 4 (very much improved). Higher values represent a better outcome.
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. 24 weeks 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.
Trial Locations
- Locations (3)
Tennessee Clinical Research Center
🇺🇸Nashville, Tennessee, United States
Aesthetic Eyelid Plastic Surgery
🇺🇸Boca Raton, Florida, United States
Dallas Plastic Surgery Institute
🇺🇸Dallas, Texas, United States