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

NCT ID: NCT03652844

Last Updated: 2021-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-27
• Study Completion Date: 2019-07-12

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Allograft Adipose Matrix (AAM) 1.0

Group Type: ACTIVE_COMPARATOR

AAM

Intervention Type: PROCEDURE

Subcutaneous injection procedure

Allograft Adipose Matrix (AAM) Diluted

Group Type: ACTIVE_COMPARATOR

AAM

Intervention Type: PROCEDURE

Subcutaneous injection procedure

Interventions

AAM

Subcutaneous injection procedure

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Musculoskeletal Transplant Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Aesthetic Eyelid Plastic Surgery

Boca Raton, Florida, United States

Tennessee Clinical Research Center

Nashville, Tennessee, United States

Dallas Plastic Surgery Institute

Dallas, Texas, United States

Countries

United States

Other Identifiers

MTF 18-04-01

Identifier Type: -

Identifier Source: org_study_id