Facial Volume DeficitPhase 3NCT05818709
A Study to Assess Adverse Events and Effectiveness of HAC 22L Injection for Mid-Face Volume in Adult Participants
A Phase 3 study testing HAC 22L in people with Facial Volume Deficit, run by AbbVie at 17 sites in 2 countries.
Trial summary
Collagen, elastin, and glycosaminoglycans, (eg, hyaluronic acid) are predominant component of the skin and they are key contributor to its characteristics such as strength, elasticity, and plumpness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Facial Volume Deficit
- What is being tested?
- HAC 22L
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 17 sitesin 2 countries
- Study dates
- 14 Jun 2023to 5 Dec 2025
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant in general good health
- Seeking improvement/correction of mid-face volume
- Participant has overall mid-face severity of Moderate (3), Significant (4), or Severe (5) on the 6-point photonumeric MFVDS as assessed by the EI
- Participant capable of giving signed informed consent
Who cannot join
- Has experienced trauma to the mid-face within 6 months before enrollment or has residual deficiencies, deformities, or scarring.
- Conditions that could interfere with device effectiveness such as current cutaneous or mucosal inflammatory or infectious processes (eg, herpes), rosacea, abscess, an unhealed wound, active acne, or a cancerous or precancerous lesion in the mid-face
- History of keloid scar formation, hypertrophic scarring, and/or post inflammatory hyperpigmentation
- History of pigmentation disorders or current pigmentation disorder in the face
- A history of facial surgeries in the mid-face
- Received fat injection or permanent implants (eg, polymethylmethacrylate, silicone, polytetrafluoroethylene) anywhere in the face, or is planning to be implanted with any of these products at any time during the study
Show all 14Show fewer
- Received semipermanent soft-tissue filler treatment (eg, calcium hydroxyapatite, poly-L-lactic acid) in the mid-face within 36 months before enrollment, or is planning to be implanted with any of these products at any time during the study
- Temporary soft tissue filler injections in the mid-face within 24 months before enrollment
- Received botulinum toxin treatment to the midface within 6 months before enrollment, or is planning to undergo any such treatment during the study
- Received mesotherapy or cosmetic facial procedures in the mid-face within 6 months before enrollment, or is planning to undergo any such treatment during the study
- Any over-the-counter or prescription oral or topical, anti-wrinkle products for the mid-face within 30 days before enrollment (participants who have been on a regimen of such products for at least 30 days are eligible for the study if they intend to continue their regimen throughout the study)
- Is on a prescribed regimen of anti-coagulation therapy (eg, warfarin, clopidogrel)
- Tattoos, piercings, hair, or scars that would interfere with visualization of the cheek area for the effectiveness assessments
- Pregnant, nursing, or planning a pregnancy
Trial locations and contacts
17 sites in 2 countries.
17 sites in 2 countries
Germany11 sites
Dermatologie Mahlow /ID# 243805
Blankenfelde-Mahlow, Brandenburg, 15831
Hautarztpraxis Dr. Niesmann und Dr. Othlinghaus /ID# 243802
Bochum, North Rhine-Westphalia, 44793
Hautzentrum Koeln /ID# 244607
Cologne, North Rhine-Westphalia, 50996
Rosenpark Research /ID# 243804
Darmstadt, Hesse, 64283
Privatpraxis Dr. Hilton & Partner /ID# 243798
Düsseldorf, North Rhine-Westphalia, 40212
Universitaet Hamburg /ID# 251970
Hamburg, 20146
Noahklinik GmbH /ID# 244610
Kassel, 34117
Privatpraxis fuer Dermatologie und Aesthetik /ID# 243803
München, 80539
Hautok and Hautok-cosmetics /ID# 243800
Munich, Bavaria, 80333
MediCorium Zentrum fuer Dermatologie und Aesthetik /ID# 243799
Oberursel, Hesse, 61440
Haut- und Lasercentrum Potsdam /ID# 243822
Potsdam, Brandenburg, 14467
Spain6 sites
Antiaging Group Barcelona (AGB) /ID# 245446
Barcelona, 08021
Instituto de Medicina y Dermatologia Avanzada (IMDA) /ID# 243339
Madrid, 28001
Sclinic /Id# 243340
Madrid, 28001
Grupo Pedro Jaen /ID# 243347
Madrid, 28006
Instituto de Dermatologia Integral (IDEI) /ID# 245764
Madrid, 28009
Instituto Medico Miramar /ID# 251640
Málaga, Malaga, 29016
About this study
Official title: A Multicenter, Evaluator-blinded, Randomized, Delayed Treatment Control Study of the Safety and Effectiveness of HAC 22L for Improving Midface Volume
Collagen, elastin, and glycosaminoglycans, (eg, hyaluronic acid) are predominant component of the skin and they are key contributor to its characteristics such as strength, elasticity, and plumpness. Chronic reduction in any one of these components as well as a loss of muscle and fat mass contribute to the facial volume loss that characterizes the aging face. HAC 22L is a dermal filler administered via subcutaneous/supraperiosteal injection for volumizing effect. The purpose of the study is to assess adverse events and effectiveness of HAC 22L in adults with facial volume deficit.
HAC 22L is a novel injectable device being developed to improve mid-face volume. Participants are placed in 1 of 2 groups, called treatment arms. There is a 1 in 3 chance that participants will be assigned to the control group. Around 75 adult participants seeking improvement of mid-face volume will be enrolled in the study at approximately 20 sites worldwide.
Read more
Participants in the treatment group will receive HAC 22L injection at Day 1. Participants will have the opportunity to receive optional touch-up and will be followed for up to 24 months. An optional repeat treatment will be offered after the follow-up period. Participants in the control group will followed for 6 months (no treatment period). At completion of the control period, participants may exit or opt to receive the study treatment (inclusive of optional touch-up). Participants will then be followed for 6 months. No repeat treatment is offered to the control group.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by different methods such as medical assessments, questionnaires and instrument's measures.
- Conditions
- Facial Volume Deficit
- Being tested
- HAC 22L
- Keywords
- Mid-Face Volume, HAC 22L, VOLUMIZE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HAC 22LDevice
Subcutaneous and/or Supraperiosteal injection
| Study group | Role | What they receive |
|---|---|---|
| HAC 22L | Experimental | Participants will be randomized to receive HAC 22L on Day 1. Participants will have the opportunity to receive optional touch-up and optional repeat treatment of HAC 22L during the follow-up period. Receives: Device: HAC 22L |
| Control Group | Other | Participants can opt to receive HAC 22L after a control period of 6 months. Participants will have the opportunity to receive an optional touch-up treatment and will be followed for an additional 6 months period. Receives: Device: HAC 22L |
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 a participant with at least 1- grade improvement (reduction) of mid face soft tissue deficit using the MFVDS. MFVDS is a validated 6-point scale (0 = None, 5 = Severe).
Measured: Month 6
Number of Participants with Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a study intervention which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of the study intervention.
Measured: Up to approximately 25 Months
Secondary outcomes (3)
Change from baseline on the Rasch transformed score of the FACE-Q Satisfaction with Cheeks module
In the FACE-Q Satisfaction with Cheeks questionnaire, the responses will be summed and converted to a Rasch transformed score that ranges from 0 to 100.
Measured: Month 6
Percentage of Participants Achieving "Responder" Status based on Evaluating Investigator (EIs) assessments of Global Aesthetic Improvement in the treatment area using the Global Aesthetic Improvement Scale (GAIS)
A "responder" is a participant who achieves "Improved" or "Much Improved" on GAIS. GAIS is a 5-point scale used to assess global aesthetic improvement of the cheek area (2=Much Improved, -2=Much Worse).
Measured: Month 6
Percentage of Participants Achieving "Responder" Status based on Participant's assessments of Global Aesthetic Improvement in the treatment area using GAIS
A "responder" is a participant who achieves "Improved" or "Much Improved" on GAIS. GAIS is a 5-point scale used to assess global aesthetic improvement of the cheek 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 posted19 Apr 2023
- Study start14 Jun 2023
- Primary completion5 Dec 2025
- Study completion5 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 61 participants (actual)
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
- NCT05818709
- Sponsor's protocol ID
- M21-846
- Status last verified
- Dec 2025
- First submitted
- 6 Apr 2023
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- 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 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Evaluator-blinded, Randomized, Delayed Treatment Control Study of the Safety and Effectiveness of HAC 22L for Improving Midface Volume
- ClinicalTrials.gov ID
- NCT05818709
- Acronym / sponsor ID
- M21-846
- Conditions
- Facial Volume Deficit
- Keywords
- Mid-Face Volume, HAC 22L, VOLUMIZE
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 14 Jun 2023 (actual)
- Primary completion
- 5 Dec 2025 (actual)
- Study completion
- 5 Dec 2025 (actual)
- First posted
- 19 Apr 2023 (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.
Collagen, elastin, and glycosaminoglycans, (eg, hyaluronic acid) are predominant component of the skin and they are key contributor to its characteristics such as strength, elasticity, and plumpness. Chronic reduction in any one of these components as well as a loss of muscle and fat mass contribute to the facial volume loss that characterizes the aging face. HAC 22L is a dermal filler administered via subcutaneous/supraperiosteal injection for volumizing effect. The purpose of the study is to assess adverse events and effectiveness of HAC 22L in adults with facial volume deficit.
HAC 22L is a novel injectable device being developed to improve mid-face volume. Participants are placed in 1 of 2 groups, called treatment arms. There is a 1 in 3 chance that participants will be assigned to the control group. Around 75 adult participants seeking improvement of mid-face volume will be enrolled in the study at approximately 20 sites worldwide.
Participants in the treatment group will receive HAC 22L injection at Day 1. Participants will have the opportunity to receive optional touch-up and will be followed for up to 24 months. An optional repeat treatment will be offered after the follow-up period. Participants in the control group will followed for 6 months (no treatment period). At completion of the control period, participants may exit or opt to receive the study treatment (inclusive of optional touch-up). Participants will then be followed for 6 months. No repeat treatment is offered to the control group.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by different methods such as medical assessments, questionnaires and instrument's measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HAC 22L | Experimental | Device: HAC 22LParticipants will be randomized to receive HAC 22L on Day 1. Participants will have the opportunity to receive optional touch-up and optional repeat treatment of HAC 22L during the follow-up period. |
| Control Group | Other | Device: HAC 22LParticipants can opt to receive HAC 22L after a control period of 6 months. Participants will have the opportunity to receive an optional touch-up treatment and will be followed for an additional 6 months period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participant in general good health
- Seeking improvement/correction of mid-face volume
- Participant has overall mid-face severity of Moderate (3), Significant (4), or Severe (5) on the 6-point photonumeric MFVDS as assessed by the EI
- Participant capable of giving signed informed consent
Key exclusion criteria (14 listed)
- Has experienced trauma to the mid-face within 6 months before enrollment or has residual deficiencies, deformities, or scarring.
- Conditions that could interfere with device effectiveness such as current cutaneous or mucosal inflammatory or infectious processes (eg, herpes), rosacea, abscess, an unhealed wound, active acne, or a cancerous or precancerous lesion in the mid-face
- History of keloid scar formation, hypertrophic scarring, and/or post inflammatory hyperpigmentation
- History of pigmentation disorders or current pigmentation disorder in the face
- A history of facial surgeries in the mid-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 |
|---|---|---|
| HAC 22LSubcutaneous and/or Supraperiosteal injection | Device | Control Group, HAC 22L |
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 a participant with at least 1- grade improvement (reduction) of mid face soft tissue deficit using the MFVDS. MFVDS is a validated 6-point scale (0 = None, 5 = Severe).
Number of Participants with Adverse Events
Time frame: Up to approximately 25 Months
An adverse event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a study intervention which does not necessarily have a causal relationship with the treatment. The investigator assesses the relationship of each event to the use of the study intervention.
3 secondary outcomes
Change from baseline on the Rasch transformed score of the FACE-Q Satisfaction with Cheeks module
Time frame: Month 6
Percentage of Participants Achieving "Responder" Status based on Evaluating Investigator (EIs) assessments of Global Aesthetic Improvement in the treatment area using the Global Aesthetic Improvement Scale (GAIS)
Time frame: Month 6
Percentage of Participants Achieving "Responder" Status based on Participant's assessments of Global Aesthetic Improvement in the treatment area using GAIS
Time frame: Month 6
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 26 Dec 2025.
- 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 Facial Volume Deficit
Active, not recruiting
Clinical Investigation for Evaluating the Safety and Efficacy of JTM102 to Mid Face Volume Deficiency
Mid Face Volume Deficit
RecruitingPhase 3
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
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. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
17 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HAC 22L in people with Facial Volume Deficit, run by AbbVie at 17 sites in 2 countries.
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 4 inclusion and 14 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 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Germany, Spain. 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?
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?
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 26 Dec 2025.