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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03652844
Recruitment Status : Active, not recruiting
First Posted : August 29, 2018
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Age-Related Atrophy Procedure: AAM Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized cohorts
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 27, 2018
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

  2. Three-D facial photography (Canfield) with computation of volume changes at 24 weeks compared to pre-treatment. [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03652844


Locations
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United States, Florida
Aesthetic Eyelid Plastic Surgery
Boca Raton, Florida, United States, 33431
United States, Tennessee
Tennessee Clinical Research Center
Nashville, Tennessee, United States, 37215
United States, Texas
Dallas Plastic Surgery Institute
Dallas, Texas, United States, 75231
Sponsors and Collaborators
Musculoskeletal Transplant Foundation

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Responsible Party: Musculoskeletal Transplant Foundation
ClinicalTrials.gov Identifier: NCT03652844    
Other Study ID Numbers: MTF 18-04-01
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrophy
Pathological Conditions, Anatomical