Mid Face Volume DeficitPhase 3NCT06734351
A Study to Evaluate Safety and Effectiveness of NOA VOLUME Injectable Gel in Adult Participants Compared to JUVÉDERM VOLUMA XC for Improvement of Mid-Face Volume
A Phase 3 study testing NOA VOLUME and VOLUMA XC in people with Mid Face Volume Deficit, run by AbbVie at 15 sites in United States.
Trial summary
Facial fullness is often regarded as a characteristic feature of a youthful face. Chronic reduction of collagen, elastin, and glycosaminoglycans contribute to the facial volume loss that characterizes the aging face. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Mid Face Volume Deficit
- What is being tested?
- NOA VOLUME and VOLUMA XC
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 231 participants
- Where
- 15 sitesUnited States
- Study dates
- 16 Dec 2024to Jul 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has moderate (3), significant (4), or severe (5) mid-face volume deficit on the 5-point photonumeric MFVDS based on evaluating investigator's (EI) live assessment.
- Mid-face is amenable to achieving at least a 1-point improvement in MFVDS score with the allowed injection volume in the treating investigator's (TI) judgement.
Who cannot join
- Significant skin laxity in the midface in the opinion of the TI.
- Significant skin pigmentation disorders or discoloration in the mid-face area that would interfere with the visual assessment of the mid-face area.
- Current cutaneous inflammatory or infectious processes (e.g., acne, herpes), abscess, unhealed wound, or cancerous or precancerous lesion on the face.
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
United States15 sites, 15 recruiting
- Recruiting
SkinDC /ID# 258163
Arlington, Virginia, 22209
- Recruiting
Atlanta Biomedical Clinical Research /ID# 261210
Atlanta, Georgia, 30331-2160
Site Coordinator, 678-515-3446
- Recruiting
Westlake Dermatology & Cosmetic Surgery - Westlake /ID# 258156
Austin, Texas, 78746-4720
- Recruiting
Aesthetic Center at Woodholme /ID# 258166
Baltimore, Maryland, 21208-6391
- Recruiting
Total Skin and Beauty Dermatology Center /ID# 258164
Birmingham, Alabama, 35205
- Recruiting
Susan H. Weinkle MD /ID# 258160
Bradenton, Florida, 34209-5642
- Recruiting
EthiQ2 Research, LLC /ID# 258906
Brookfield, Wisconsin, 53005
- Recruiting
Hevia Cosmetic Dermatology /ID# 258165
Coral Gables, Florida, 33134
- Recruiting
Skin Research Institute LLC /ID# 258158
Coral Gables, Florida, 33146-1837
- Recruiting
Advanced Research Associates - Glendale /ID# 276812
Glendale, Arizona, 85308
- Recruiting
Edwin F. Williams III, MD FACS of LATHAM P.C. D/B/A THE REJUVA CENTER /ID# 261211
Latham, New York, 12110
- Recruiting
Pure Dermatology /ID# 258168
Metairie, Louisiana, 70001
- Recruiting
Jane Yoo MD /ID# 279811
New York, New York, 10019
- Recruiting
Northwest Dermatology Institute /ID# 258167
Portland, Oregon, 97210-2859
- Recruiting
West Dermatology La Jolla /ID# 278590
San Diego, California, 92121
About this study
Official title: A Multicenter, Evaluator and Subject-blinded, Randomized, Comparator-controlled, Parallel-design Study to Evaluate the Safety and Effectiveness of NOA VOLUME Compared to JUVÉDERM® VOLUMA® XC for Improvement of Mid-face Volume
Facial fullness is often regarded as a characteristic feature of a youthful face. Chronic reduction of collagen, elastin, and glycosaminoglycans contribute to the facial volume loss that characterizes the aging face. Volume restoration by replacing or augmenting soft tissue is critical to successful facial rejuvenation. NOA VOLUME is a crosslinked Hyaluronic Acid (HA) injectable gel formulated with lidocaine that was developed to provide a safe, minimally invasive method of improving mid-face volume deficit. The purpose of this study is to assess safety and effectiveness of NOA VOLUME in adult participants seeking improvement of mid-face volume compared to JUVÉDERM VOLUMA XC (VOLUMA XC).
NOA VOLUME is an investigational device being developed for the improvement of mid-face volume. There will be 2 cohorts in this study. Participants will receive either NOA VOLUME or VOLUMA XC. Around 231 adult participants seeking improvement of mid-face volume will be enrolled in the study at approximately 15 sites in the United States.
Participants will receive either NOA VOLUME or VOLUMA XC injections in the cheek area on Day 1. Participants will receive optional touch-up treatment at Day 31 and optional repeat treatment at Month 18 and will be followed up for up to 31 months.
- Conditions
- Mid Face Volume Deficit
- Being tested
- NOA VOLUME, VOLUMA XC
- Keywords
- Mid Face Volume Deficit, NOA VOLUME, JUVÉDERM® VOLUMA® XC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOA VOLUMEDevice
Injections
VOLUMA XCDevice
Also called JUVÉDERM
Injections
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: NOA VOLUME | Experimental | Participants will receive NOA VOLUME on Day 1 with optional touch-up treatment on Day 31 and Month 18. Receives: Device: NOA VOLUME |
| Cohort 1: VOLUMA XC | Experimental | Participants will receive VOLUMA XC on Day 1 with optional touch-up treatment on Day 31 and Month 18. Receives: Device: VOLUMA XC |
| Cohort 2: NOA VOLUME | Experimental | Participants will receive NOA VOLUME on Day 1 with optional touch-up treatment on Day 31 and Month 18. Receives: Device: NOA VOLUME |
| Cohort 2: VOLUMA XC | Experimental | Participants will receive VOLUMA XC on Day 1 with optional touch-up treatment on Day 31 and Month 18. Receives: Device: VOLUMA XC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving "Responder" Status Based on the Evaluating Investigator's (EI) Live Assessment of Mid-Face Volume Deficit Scale (MFVDS)
A "responder" is defined as a participant with at least 1-point improvement (reduction) of mid face volume deficit using the MFVDS. MFVDS is a validated 5-point scale (1 = None/Minimal to 5 = Severe).
Measured: Month 6
Number of Participants with Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Measured: Up to Approximately Month 31
Secondary outcomes (3)
Change from Baseline in the Overall Score of FACE-Q Satisfaction with Cheeks
The FACE-Q Satisfaction with Cheeks questionnaire is a 5-point survey where 1 = Very Dissatisfied and 4 = Very Satisfied.
Measured: Month 6
Percentage of Participants Achieving "Responder" Status Based on Participant's Assessments of Global Aesthetic Improvement in the Treatment Area Using Global Aesthetic Improvement Scale (GAIS)
A "responder" is defined as a participant who achieves "Improved" or "Much Improved" on GAIS. GAIS is a 5-point scale used to assess global aesthetic improvement of the treatment area (2 = Much Improved to -2 = Much Worse).
Measured: Month 6
Percentage of Participants Achieving "Responder" Status Based on EI's Assessments of Global Aesthetic Improvement in the Treatment Area Using the GAIS
A "responder" is defined as a participant who achieves "Improved" or "Much Improved" on GAIS. GAIS is a 5-point scale used to assess global aesthetic improvement of the treatment area (2 = Much Improved, -2 = Much Worse).
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start16 Dec 2024
- Primary completionJul 2029 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mid Face Volume DeficitStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 231 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06734351
- Sponsor's protocol ID
- M21-841
- Status last verified
- Jun 2026
- First submitted
- 11 Dec 2024
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Evaluator and Subject-blinded, Randomized, Comparator-controlled, Parallel-design Study to Evaluate the Safety and Effectiveness of NOA VOLUME Compared to JUVÉDERM® VOLUMA® XC for Improvement of Mid-face Volume
- ClinicalTrials.gov ID
- NCT06734351
- Acronym / sponsor ID
- M21-841
- Conditions
- Mid Face Volume Deficit
- Keywords
- Mid Face Volume Deficit, NOA VOLUME, JUVÉDERM® VOLUMA® XC
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 231 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2024 (actual)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 16 Dec 2024 (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.
Facial fullness is often regarded as a characteristic feature of a youthful face. Chronic reduction of collagen, elastin, and glycosaminoglycans contribute to the facial volume loss that characterizes the aging face. Volume restoration by replacing or augmenting soft tissue is critical to successful facial rejuvenation. NOA VOLUME is a crosslinked Hyaluronic Acid (HA) injectable gel formulated with lidocaine that was developed to provide a safe, minimally invasive method of improving mid-face volume deficit. The purpose of this study is to assess safety and effectiveness of NOA VOLUME in adult participants seeking improvement of mid-face volume compared to JUVÉDERM VOLUMA XC (VOLUMA XC).
NOA VOLUME is an investigational device being developed for the improvement of mid-face volume. There will be 2 cohorts in this study. Participants will receive either NOA VOLUME or VOLUMA XC. Around 231 adult participants seeking improvement of mid-face volume will be enrolled in the study at approximately 15 sites in the United States.
Participants will receive either NOA VOLUME or VOLUMA XC injections in the cheek area on Day 1. Participants will receive optional touch-up treatment at Day 31 and optional repeat treatment at Month 18 and will be followed up for up to 31 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: NOA VOLUME | Experimental | Device: NOA VOLUMEParticipants will receive NOA VOLUME on Day 1 with optional touch-up treatment on Day 31 and Month 18. |
| Cohort 1: VOLUMA XC | Experimental | Device: VOLUMA XCParticipants will receive VOLUMA XC on Day 1 with optional touch-up treatment on Day 31 and Month 18. |
| Cohort 2: NOA VOLUME | Experimental | Device: NOA VOLUMEParticipants will receive NOA VOLUME on Day 1 with optional touch-up treatment on Day 31 and Month 18. |
| Cohort 2: VOLUMA XC | Experimental | Device: VOLUMA XCParticipants will receive VOLUMA XC on Day 1 with optional touch-up treatment on Day 31 and Month 18. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Has moderate (3), significant (4), or severe (5) mid-face volume deficit on the 5-point photonumeric MFVDS based on evaluating investigator's (EI) live assessment.
- Mid-face is amenable to achieving at least a 1-point improvement in MFVDS score with the allowed injection volume in the treating investigator's (TI) judgement.
Key exclusion criteria (3 listed)
- Significant skin laxity in the midface in the opinion of the TI.
- Significant skin pigmentation disorders or discoloration in the mid-face area that would interfere with the visual assessment of the mid-face area.
- Current cutaneous inflammatory or infectious processes (e.g., acne, herpes), abscess, unhealed wound, or cancerous or precancerous lesion on the face.
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 |
|---|---|---|
| NOA VOLUMEInjections | Device | Cohort 1: NOA VOLUME, Cohort 2: NOA VOLUME |
| VOLUMA XCAlso: JUVÉDERMInjections | Device | Cohort 1: VOLUMA XC, Cohort 2: VOLUMA XC |
Primary outcome
Percentage of Participants Achieving "Responder" Status Based on the Evaluating Investigator's (EI) Live Assessment of Mid-Face Volume Deficit Scale (MFVDS)
Time frame: Month 6
A "responder" is defined as a participant with at least 1-point improvement (reduction) of mid face volume deficit using the MFVDS. MFVDS is a validated 5-point scale (1 = None/Minimal to 5 = Severe).
Number of Participants with Adverse Events (AEs)
Time frame: Up to Approximately Month 31
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
3 secondary outcomes
Change from Baseline in the Overall Score of FACE-Q Satisfaction with Cheeks
Time frame: Month 6
Percentage of Participants Achieving "Responder" Status Based on Participant's Assessments of Global Aesthetic Improvement in the Treatment Area Using Global Aesthetic Improvement Scale (GAIS)
Time frame: Month 6
Percentage of Participants Achieving "Responder" Status Based on EI's Assessments of Global Aesthetic Improvement in the Treatment Area Using the GAIS
Time frame: Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: Yes. AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Related trials for Mid Face Volume Deficit
Active, not recruiting
Clinical Investigation for Evaluating the Safety and Efficacy of JTM102 to Mid Face Volume Deficiency
Mid Face Volume Deficit
Active, not recruiting
Evaluation of Performance and Safety of Injectable KIO017 Device Range for Facial Tissue Filling
Dermal Fillers, Cheek Augmentation
Recruiting
Evaluation of Efficacy and Safety of Alcarisa (Hyaluronic Acid Produced by Espad Pharmed Co.) for Restoration of Mid-face Volume
Mid Face Volume Deficit
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.
ABBVIE INC. study director
AbbVie
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NOA VOLUME and VOLUMA XC in people with Mid Face Volume Deficit, run by AbbVie at 15 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 2 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ABBVIE CALL CENTER (844-663-3742, abbvieclinicaltrials@abbvie.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving "Responder" Status Based on the Evaluating Investigator's (EI) Live Assessment of Mid-Face Volume Deficit Scale (MFVDS) (time frame: Month 6). 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 18 Jun 2026.