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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Florida
      • Boca Raton, Florida, United States, 33431
        • Aesthetic Eyelid Plastic Surgery
    • Tennessee
      • Nashville, Tennessee, United States, 37215
        • Tennessee Clinical Research Center
    • Texas
      • Dallas, Texas, United States, 75231
        • Dallas Plastic Surgery Institute

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

26 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Allograft Adipose Matrix (AAM) 1.0
Procedure: AAM
Subcutaneous injection procedure
Active Comparator: Allograft Adipose Matrix (AAM) Diluted
Procedure: AAM
Subcutaneous injection procedure

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Musculoskeletal Transplant Foundation

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 27, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 12, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 12, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 28, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 29, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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