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

NCT03652844 | Completed

• 1 other identifier: MTF 18-04-01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

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.

Conditions

Age-Related Atrophy

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  24 weeks

Secondary Outcomes (2)

• 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

• Volume change assessments using the Global Aesthetic Improvement Scale (GAIS) at 24 weeks post-treatment compared to pre-treatment

  24 weeks

Study Arms (2)

Allograft Adipose Matrix (AAM) 1.0

ACTIVE COMPARATOR

Procedure: AAM

Allograft Adipose Matrix (AAM) Diluted

ACTIVE COMPARATOR

Procedure: AAM

Interventions

AAM PROCEDURE

Subcutaneous injection procedure

Allograft Adipose Matrix (AAM) 1.0; Allograft Adipose Matrix (AAM) Diluted

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Musculoskeletal Transplant Foundation: lead

Study Sites (3)

Aesthetic Eyelid Plastic Surgery

Boca Raton, Florida, 33431, United States

Location

Tennessee Clinical Research Center

Nashville, Tennessee, 37215, United States

Location

Dallas Plastic Surgery Institute

Dallas, Texas, 75231, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized cohorts

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: August 29, 2018
• Study Start: August 27, 2018
• Primary Completion: July 12, 2019
• Study Completion: July 12, 2019
• Last Updated: May 11, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)