Age-Related AtrophyNCT03652844
Use of AAM for Correction of Age Related Volume Deficits in the Face
A study testing AAM in people with Age-Related Atrophy, run by Musculoskeletal Transplant Foundation at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Age-Related Atrophy
- What is being tested?
- AAM
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 3 sitesUnited States
- Study dates
- 27 Aug 2018to 12 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 26Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Aesthetic Eyelid Plastic Surgery
Boca Raton, Florida, 33431
Dallas Plastic Surgery Institute
Dallas, Texas, 75231
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
About this study
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
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
- Being tested
- AAM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AAMProcedure or surgery
Subcutaneous injection procedure
| Study group | Role | What they receive |
|---|---|---|
| Allograft Adipose Matrix (AAM) 1.0 | Active comparator | Not described Receives: Procedure: AAM |
| Allograft Adipose Matrix (AAM) Diluted | Active comparator | Not described Receives: Procedure: AAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
Three-D facial photography (Canfield) with computation of volume changes at 24 weeks compared to pre-treatment.
Measured: 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.
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.
Measured: 24 weeks
Volume change assessments using the Global Aesthetic Improvement Scale (GAIS) at 24 weeks post-treatment compared to pre-treatment
GAIS rates improvement in appearance. Scores range from 0 (worse) to 4 (very much improved). Higher values represent a better outcome.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start27 Aug 2018
- Primary completion12 Jul 2019
- Study completion12 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related AtrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized cohorts
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Musculoskeletal Transplant Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03652844
- Sponsor's protocol ID
- MTF 18-04-01
- Status last verified
- May 2021
- First submitted
- 28 Aug 2018
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03652844
- Acronym / sponsor ID
- MTF 18-04-01
- Conditions
- Age-Related Atrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Musculoskeletal Transplant FoundationUniversity, hospital or other
- Study start
- 27 Aug 2018 (actual)
- Primary completion
- 12 Jul 2019 (actual)
- Study completion
- 12 Jul 2019 (actual)
- First posted
- 29 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized cohorts
| Arm | Type | Receives |
|---|---|---|
| Allograft Adipose Matrix (AAM) 1.0 | Active comparator | Procedure: AAM |
| Allograft Adipose Matrix (AAM) Diluted | Active comparator | Procedure: AAM |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (26 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AAMSubcutaneous injection procedure | Procedure or surgery | Allograft Adipose Matrix (AAM) 1.0, Allograft Adipose Matrix (AAM) Diluted |
Primary outcome
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.
Three-D facial photography (Canfield) with computation of volume changes at 24 weeks compared to pre-treatment.
Time frame: 24 weeks
2 secondary outcomes
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
Volume change assessments using the Global Aesthetic Improvement Scale (GAIS) at 24 weeks post-treatment compared to pre-treatment
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
- Individual participant dataSharing planned: No
Related trials for Age-Related Atrophy
Not yet recruitingPhase 2
MF-300 for Treatment of Age-Related Sarcopenia
Sarcopenia in Elderly
Active, not recruitingPhase 1/2
Phase 1/2 Study of VOY-101 in Patients With Advanced Non-Neovascular Age-Related Macular Degeneration
Age-Related Macular Degeneration, Geographic Atrophy
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
RecruitingPhase 3
A Study Investigating Subcutaneously Administered Pozelimab in Combination With Cemdisiran or Cemdisiran Alone in Adult Participants With Geographic Atrophy
Age-related Macular Degeneration (AMD), Geographic Atrophy (GA)
RecruitingPhase 1
Phase 1 Study of C.001 in Retinal Degeneration
Geographic Atrophy, Stargardt Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AAM in people with Age-Related Atrophy, run by Musculoskeletal Transplant Foundation at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2021.