Mid Face Volume DeficitPhase 3NCT07032597
A Study to Assess Safety and Effectiveness of HArmonyCa Lidocaine Injectable Gel for Restoration and/or Creation of Mid-Face Volume in Adult Participants
A Phase 3 study testing HArmonyCa Lidocaine Injectable Gel and Restylane® Perlane® Lidocaine in people with Mid Face Volume Deficit, run by AbbVie at 9 sites in China.
Trial summary
The cumulative effect of aging and environmental exposures (ie, ultraviolet, infrared, and visible light radiation and pollution) leads to wrinkles, discoloration, laxity, and roughness of sun exposed skin. The rapid restoration of soft tissue augmentation is commonly achieved by the use of dermal fillers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mid Face Volume Deficit
- What is being tested?
- HArmonyCa Lidocaine Injectable Gel and Restylane® Perlane® Lidocaine
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 9 sitesChina
- Study dates
- 26 May 2025to 3 Sep 2026
- 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
- Has moderate (3), significant (4), or severe (5) mid-face volume deficit on the Mid-face Volume Deficit Scale (MFVDS) 5-point photonumeric scale based on evaluating investigator (EI) live assessment at randomization visit.
- Mid-face areas are amenable to achieving at least a 1-point improvement in MFVDS score with the allowed injection volume in the treating investigator's (TI) judgment.
- Must be in good health as determined by medical history, physical examination, vital signs, and investigator's judgment, including no known active pandemic infection.
Who cannot join
- Excessive skin laxity in the mid-face area 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.
- Semi-permanent soft tissue filler treatment (e.g., CaHA, poly-L-lactic acid) in the face within 36 months before randomization.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
Beijing Hospital /ID# 272476
Beijing, Beijing Municipality, 100005
Peking Union Medical College Hospital (West) - Xidan Campus /ID# 272480
Beijing, Beijing Municipality, 100032
The First Peoples Hospital of Hangzhou /ID# 272475
Hangzhou, Zhejiang, 310006
Nanjing Drum Tower Hospital /ID# 272468
Nanjing, Jiangsu, 210008
Zhongda Hospital Southeast University /ID# 272471
Nanjing, Jiangsu, 210009
Huashan Hospital Of Fudan University /ID# 272632
Shanghai, Shanghai Municipality, 200040
Shanghai Tongji Hospital /ID# 272509
Shanghai, Shanghai Municipality, 200065
Union Hospital Tongji Medical College Huazhong University of Science and Tech /ID# 272631
Wuhan, Hubei, 430022
Wuxi Peoples Hospital /ID# 275928
Wuxi, Jiangsu, 214023
About this study
Official title: A Multicenter, Evaluator Blinded, Randomized Study to Evaluate the Safety and Effectiveness of HArmonyCa Lidocaine Compared to Restylane® Perlane® Lidocaine for Restoration and/or Creation of Mid-face Volume
The cumulative effect of aging and environmental exposures (ie, ultraviolet, infrared, and visible light radiation and pollution) leads to wrinkles, discoloration, laxity, and roughness of sun exposed skin. The rapid restoration of soft tissue augmentation is commonly achieved by the use of dermal fillers. HArmonyCa Lidocaine injectable gel is a dermal filler intended for facial soft tissue augmentation. The purpose of this study is to assess adverse events and effectiveness of HArmonyCa Lidocaine injectable gel compared to Restylane® Perlane® Lidocaine (Perlane) in adults seeking restoration and/or correction of moderate to severe mid-face volume deficit.
HArmonyCa Lidocaine Injectable Gel is an investigational device being developed for soft tissue augmentation in the mid face. 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 receive active comparator, Perlane. Around 252 adult participants seeking restoration and/or creation of mid-face volume will be enrolled in the study at approximately 9 sites in China.
Read more
Participants will receive HArmonyCa Lidocaine injectable gel or Perlane at Day 1 with an option touch-up treatment on Day 31. Participants will be followed for up to 12 Months after last treatment.
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. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.
- Conditions
- Mid Face Volume Deficit
- Being tested
- HArmonyCa Lidocaine Injectable Gel, Restylane® Perlane® Lidocaine
- Keywords
- Mid Face Volume Deficit, HArmonyCa Lidocaine, Restylane® Perlane® Lidocaine, Mid-Face China
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HArmonyCa Lidocaine Injectable GelDevice
Subdermal or Deep Dermal or Supraperiosteal Injection
Restylane® Perlane® LidocaineDevice
Subcutaneous to Supraperiosteal Implantation Injection
| Study group | Role | What they receive |
|---|---|---|
| HArmonyCa Lidocaine | Experimental | Participants will receive HArmonyCa Lidocaine on Day 1 with optional touch-up treatment on Day 31. Receives: Device: HArmonyCa Lidocaine Injectable Gel |
| Restylane® Perlane® Lidocaine | Active comparator | Participants will receive Perlane on Day 1 with optional touch-up treatment on Day 31. Receives: Device: Restylane® Perlane® Lidocaine |
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-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 medical device which does not necessarily have a causal relationship with this treatment.
Measured: Up to Approximately Month 14
Secondary outcomes (3)
Percentage of Participants Achieving "Responder" Status Based on EI's 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 treatment 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 treatment area (2 = Much Improved to -2 = Much Worse).
Measured: Month 6
Change from Baseline on 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start26 May 2025
- Primary completion3 Sep 2026
- Study completion3 Sep 2026
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 252 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
- NCT07032597
- Sponsor's protocol ID
- M21-782
- Status last verified
- Sep 2026
- First submitted
- 16 Jun 2025
- Last updated
- 5 Oct 2026
- 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 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Evaluator Blinded, Randomized Study to Evaluate the Safety and Effectiveness of HArmonyCa Lidocaine Compared to Restylane® Perlane® Lidocaine for Restoration and/or Creation of Mid-face Volume
- ClinicalTrials.gov ID
- NCT07032597
- Acronym / sponsor ID
- M21-782
- Conditions
- Mid Face Volume Deficit
- Keywords
- Mid Face Volume Deficit, HArmonyCa Lidocaine, Restylane® Perlane® Lidocaine, Mid-Face China
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 252 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 26 May 2025 (actual)
- Primary completion
- 3 Sep 2026 (actual)
- Study completion
- 3 Sep 2026 (actual)
- First posted
- 24 Jun 2025 (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 cumulative effect of aging and environmental exposures (ie, ultraviolet, infrared, and visible light radiation and pollution) leads to wrinkles, discoloration, laxity, and roughness of sun exposed skin. The rapid restoration of soft tissue augmentation is commonly achieved by the use of dermal fillers. HArmonyCa Lidocaine injectable gel is a dermal filler intended for facial soft tissue augmentation. The purpose of this study is to assess adverse events and effectiveness of HArmonyCa Lidocaine injectable gel compared to Restylane® Perlane® Lidocaine (Perlane) in adults seeking restoration and/or correction of moderate to severe mid-face volume deficit.
HArmonyCa Lidocaine Injectable Gel is an investigational device being developed for soft tissue augmentation in the mid face. 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 receive active comparator, Perlane. Around 252 adult participants seeking restoration and/or creation of mid-face volume will be enrolled in the study at approximately 9 sites in China.
Participants will receive HArmonyCa Lidocaine injectable gel or Perlane at Day 1 with an option touch-up treatment on Day 31. Participants will be followed for up to 12 Months after last treatment.
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. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HArmonyCa Lidocaine | Experimental | Device: HArmonyCa Lidocaine Injectable GelParticipants will receive HArmonyCa Lidocaine on Day 1 with optional touch-up treatment on Day 31. |
| Restylane® Perlane® Lidocaine | Active comparator | Device: Restylane® Perlane® LidocaineParticipants will receive Perlane on Day 1 with optional touch-up treatment on Day 31. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Has moderate (3), significant (4), or severe (5) mid-face volume deficit on the Mid-face Volume Deficit Scale (MFVDS) 5-point photonumeric scale based on evaluating investigator (EI) live assessment at randomization visit.
- Mid-face areas are amenable to achieving at least a 1-point improvement in MFVDS score with the allowed injection volume in the treating investigator's (TI) judgment.
- Must be in good health as determined by medical history, physical examination, vital signs, and investigator's judgment, including no known active pandemic infection.
Key exclusion criteria (3 listed)
- Excessive skin laxity in the mid-face area 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.
- Semi-permanent soft tissue filler treatment (e.g., CaHA, poly-L-lactic acid) in the face within 36 months before randomization.
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 |
|---|---|---|
| HArmonyCa Lidocaine Injectable GelSubdermal or Deep Dermal or Supraperiosteal Injection | Device | HArmonyCa Lidocaine |
| Restylane® Perlane® LidocaineSubcutaneous to Supraperiosteal Implantation Injection | Device | Restylane® Perlane® Lidocaine |
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-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 14
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a medical device which does not necessarily have a causal relationship with this treatment.
3 secondary outcomes
Percentage of Participants Achieving "Responder" Status Based on EI's 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
Change from Baseline on the Overall Score of FACE-Q Satisfaction with Cheeks
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 5 Oct 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
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
9 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 HArmonyCa Lidocaine Injectable Gel and Restylane® Perlane® Lidocaine in people with Mid Face Volume Deficit, run by AbbVie at 9 sites in China.
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 3 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: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. 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 5 Oct 2026.