- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03652844
Use of AAM for Correction of Age Related Volume Deficits in the Face
May 7, 2021 updated by: Musculoskeletal Transplant Foundation
A Multi-Phase, Prospective, Multi-Center, Single-Blind, Clinical Study to Evaluate the Safety and Efficacy of Allograft Adipose Matrix (AAM) and Diluted AAM for Pre-Jowl and Malar Augmentation to Correct Age Related Volume Deficit in the Face
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
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Boca Raton, Florida, United States, 33431
- Aesthetic Eyelid Plastic Surgery
-
-
Tennessee
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Nashville, Tennessee, United States, 37215
- Tennessee Clinical Research Center
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Texas
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Dallas, Texas, United States, 75231
- Dallas Plastic Surgery Institute
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
28 years to 68 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Allograft Adipose Matrix (AAM) 1.0
|
Subcutaneous injection procedure
|
Active Comparator: Allograft Adipose Matrix (AAM) Diluted
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Subcutaneous injection procedure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: 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.
|
24 weeks
|
Three-D facial photography (Canfield) with computation of volume changes at 24 weeks compared to pre-treatment.
Time Frame: 24 weeks
|
24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: 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.
|
24 weeks
|
Volume change assessments using the Global Aesthetic Improvement Scale (GAIS) at 24 weeks post-treatment compared to pre-treatment
Time Frame: 24 weeks
|
GAIS rates improvement in appearance.
Scores range from 0 (worse) to 4 (very much improved).
Higher values represent a better outcome.
|
24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 27, 2018
Primary Completion (Actual)
July 12, 2019
Study Completion (Actual)
July 12, 2019
Study Registration Dates
First Submitted
August 28, 2018
First Submitted That Met QC Criteria
August 28, 2018
First Posted (Actual)
August 29, 2018
Study Record Updates
Last Update Posted (Actual)
May 11, 2021
Last Update Submitted That Met QC Criteria
May 7, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MTF 18-04-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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