Cheek AugmentationNCT05133739
RHA®4 for Midface Volume Deficiency
A study testing injection of RHA®4 in Midface and injection of Comparator Product in Midface in people with Cheek Augmentation and Correction of Age-related Midface Contour Deficiencies, run by Teoxane SA at 1 site in United States.
Trial summary
This is a prospective, randomized, controlled, blinded evaluator, multicenter, between subjects clinical study to identify whether RHA4 is non-inferior to a comparator device for treatment of midface volume deficiency 8 weeks after the last treatment (initial or touch-up). Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cheek Augmentation, Correction of Age-related Midface Contour Deficiencies
- What is being tested?
- injection of RHA®4 in Midface and injection of Comparator Product in Midface
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2021to 29 Jan 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Outpatient, male or female of any race, 22 years of age or older
- Female subjects of childbearing potential must have a negative UPT and practice a reliable method of contraception throughout the study.
- Seeking treatment of midface volume deficiency (realistic and achievable as per TI opinion)
- Having midface volume loss of grades 2 to 3 on the TMVDS (ranging from 0 = absent to 4 = very severe). The BLE and TI must independently assess and agree that this criterion is met; however, concordance of fullness is not required. If the assessments of the TI and the BLE are the same or differ by exactly 1 point on the scale, this difference is considered acceptable. If the assessments differ by 2 points or more on the scale, the subject will not be eligible.
- Having cheeks of the same TMVDS grade on the left and right side of the face (i.e., approximate bilateral symmetry)
- Willing to abstain from facial aesthetic procedures/therapies that could interfere with study evaluations
- Able to follow study instructions and complete all required visits.
- Sign the IRB-approved ICF, Photographic Release Form and the Authorization for Use and release of Health and Research Study Information (HIPAA) form prior to any study- related procedures being performed.
Who cannot join
- Known hypersensitivity or previous allergic reaction to any component of the study devices.
- Known sensitivity to local anesthetics of the amide type, history of multiple severe allergies, or history of anaphylactic shock.
- History of active chronic debilitating systemic disease that, in the opinion of the investigator, would make the subject a poor candidate in the study.
- History of connective tissue disease.
- Clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability.
- Exposure to any other investigational drug/device within 90 days of entering the study or planning to participate in another investigation during the course of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
United States, Massachusetts
Chestnut Hill, Massachusetts, 02467
About this study
Official title: A Randomized, Blinded Evaluator, Multicenter, Prospective, Between-subjects Clinical Study to Evaluate Safety and Effectiveness of RHA®4 for the Treatment of Midface Volume Deficiency
This is a prospective, randomized, controlled, blinded evaluator, multicenter, between subjects clinical study to identify whether RHA4 is non-inferior to a comparator device for treatment of midface volume deficiency 8 weeks after the last treatment (initial or touch-up).
At Screening, the treating investigator (TI) and the Blinded Live Evaluator (BLE) will evaluate independently the subject's midface using the validated 5-grade Teoxane Midface Volume Deficit Scale (TMVDS) for eligibility of the subject for the study. The BLE will establish a pretreatment score for assessment of effectiveness.
Read more
If the assessments of the TI and the BLE are the same or differ exactly by 1 point of the scale, the difference will be considered acceptable. The TI and the BLE need to agree that the subject meets the eligibility criterion (TMVDS grade 2 to 3). If the subject is eligible, the BLE's assessment will be used for the Baseline of the primary endpoint.
Eligible subjects will be enrolled and randomly assigned in a 3:1 ratio at Screening to receive RHA4 or comparator product.
The TI will administer the fillers, and if necessary, subjects will receive a touch-up treatment with the same product that they received on Visit 1, 4 weeks after the initial treatment to optimize the results. If the touch-up treatment is administered, the subject will be asked to come to the site for an additional visit 4 weeks after the touch-up injection.
Subjects will be followed for 52 weeks after their last treatment (initial treatment or touch-up), at which point, they will be offered re-treatment with RHA® 4, regardless of their original treatment, provided that the TI deems the treatment to be appropriate and the subject agrees. Reasons for not administering the re-treatment will be documented.
The subject will then be followed for an additional 12 weeks before exiting the study. If the subject or the TI declines re-treatment, this visit (52 weeks after the last treatment) will be considered the study Exit visit.
For subjects with re-treatment, the Exit visit will be 12 weeks after the re-treatment.
The TI will conduct safety and effectiveness evaluations at each study visit, which will occur: at 4 weeks after the initial and touch-up treatment, 8, 24, and 52 weeks after the last treatment, and after re treatment or until all treatment-related ongoing adverse events (AEs) have resolved or resolved with sequelae as per TI judgment or if follow-up is no longer possible.
A follow-up telephone call for safety will be performed 3 days after each treatment.
Subjects will report their common treatment responses (CTRs) in a subject diary for 30 days after each injection. The diary will also include a list of selected AEs potentially associated with injection of dermal fillers for subjects to report if applicable. All efforts should be made by the TI to schedule the applicable visits to allow completion of the CTR diary.
A BLE will conduct assessments of effectiveness during the study, including assessment of the primary endpoint 8 weeks after the last treatment.
The BLE will be blinded to allocation to groups (RHA4 group or comparator product group).
Furthermore, to ensure that they remain blinded and unbiased when making their assessments throughout the study, the BLE, TI, and subjects will not be allowed to refer to each other's effectiveness assessments. All subjects will be instructed to not discuss their study treatment, AEs, or CTRs with the BLE.
- Being tested
- injection of RHA®4 in Midface, injection of Comparator Product in Midface
- Keywords
- Dermal filler, Hyaluronic Acid, Midface, Cannula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injection of RHA®4 in MidfaceDevice
RHA® 4 is a sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus equi bacteria, formulated to a concentration of 23 mg/mL and 0.3% w/w lidocaine in a physiologic buffer.
Up to 3.0 mL injected per cheek (subcutaneous and/or supraperiosteal layer). Touch-up treatment provided at 4 weeks (up to 3.0 mL per cheek).
injection of Comparator Product in MidfaceDevice
Comparator product is sterile, biodegradable, colorless gel of hyaluronic acid generated by Streptococcus species of bacteria, chemically crosslinked with BDDE.
Up to 3.0 mL injected per cheek (subcutaneous and/or supraperiosteal layer). Touch-up treatment provided at 4 weeks (up to 3.0 mL per cheek).
| Study group | Role | What they receive |
|---|---|---|
| RHA®4 | Experimental | Not described Receives: Device: injection of RHA®4 in Midface |
| Comparator Device | Active comparator | Not described Receives: Device: injection of Comparator Product in Midface |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-inferiority of RHA®4 to the Change From Baseline for Subjects Treated With Comparator Product at 8 Weeks After the Last Treatment as Assessed by the BLE Using the Teoxane Midface Volume Deficit Scale (TMVDS).
A change in the TMVDS ≥1 grade compared to pretreatment will be considered clinically meaningful.
In order to confirm sensitivity 8 weeks after the last treatment: the proportion of responders with a ≥1-grade point on the TMVDS scale for Comparator product 8 weeks after the last treatment when compared to Baseline must be ≥70%.
The TMVDS is a validated 5-point scale for assessing midface volume deficit. Possible scores range from 0 (Absent) to 4 (Very Severe).
Measured: 8 weeks after the last treatment
Secondary outcomes (5)
Change From Baseline in TMVDS Score as Assessed by the BLE at 24 and 52 Weeks After Last Treatment,and Weeks After Re-treatment if Applicable.
A change in the TMVDS ≥1 grade compared to pre-treatment will be considered clinically meaningful.
The TMVDS is a validated 5-point static scale for assessing midface volume deficit. Possible scores range from 0 (Absent) to 4 (Very Severe).
Measured: Week 24, 52 after last treatment, week 12 after re-treatment
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the BLE.
he Global Aesthetic Improvement (GAI) is a subjective, balanced, 5-point dynamic scale assessing cosmetic improvement.
Possible scores range from "much improved", "improved", "no change", "worse", to "much worse".
Measured: Week 8, 24, 52 after last treatment, week 12 after re-treatment
Subject's Perception of Treatment Effectiveness as Per the "Satisfaction With Cheeks" FACE-Q Scale Questionnaire at Each Visit, at Rest.
The FACE-Q measures the experience and outcomes of aesthetic facial procedures from the patient's perspective.
The FACE-Q questionnaire is composed of 5 questions with a score linked to answers (1 being "Very Dissatisfied" and 4 being "Very Satisfied").
To calculate the FACE-Q score, outcomes from all 5 questions were pooled, data were transformed so that higher scores reflected a superior (positive) outcome, and adapted to a scale of 100 units (i.e. worst/lowest score = 0, best/highest score = 100).
Measured: Change from Baseline at Weeks 8, 24, 52 after last treatment,12 weeks after re-treatment
Subject's Perception of Treatment Effectiveness as Per the "Satisfaction With Cheeks" FACE-Q Scale Questionnaire at Each Visit, When Smiling
The FACE-Q measures the experience and outcomes of aesthetic facial procedures from the patient's perspective.
The FACE-Q questionnaire is composed of 5 questions with a score linked to answers (1 being "Very Dissatisfied" and 4 being "Very Satisfied").
To calculate the FACE-Q score, outcomes from all 5 questions were pooled, data were transformed so that higher scores reflected a superior (positive) outcome, and adapted to a scale of 100 units (i.e. worst/lowest score = 0, best/highest score = 100).
Measured: Change from Baseline at Weeks 8, 24, 52 after last treatment and 12 week after re-treatment.
Number of Subjects "Satisfied" or "Very Satisfied" With Study Treatment Using the Subject Satisfaction Scale at Weeks 8, 24, 52 After Last Treatment and 12 Weeks After Re-treatment.
The Subject Satisfaction Scale is a subjective, balanced, 5-point scale assessing subject satisfaction with study treatment. Possible scores range from with 1 (very satisfied) to 5 (very dissatisfied).
Measured: Week 8, 24, 52 after last treatment, week 12 after re-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start29 Oct 2021
- Primary completion17 Jan 2023
- Study completion29 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cheek AugmentationStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Teoxane SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05133739
- Sponsor's protocol ID
- TEO-RHA-2004
- Status last verified
- Feb 2025
- First submitted
- 22 Oct 2021
- Last updated
- 18 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Blinded Evaluator, Multicenter, Prospective, Between-subjects Clinical Study to Evaluate Safety and Effectiveness of RHA®4 for the Treatment of Midface Volume Deficiency
- ClinicalTrials.gov ID
- NCT05133739
- Acronym / sponsor ID
- TEO-RHA-2004
- Keywords
- Dermal filler, Hyaluronic Acid, Midface, Cannula
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Teoxane SAIndustry (pharma, biotech, devices)
- Study start
- 29 Oct 2021 (actual)
- Primary completion
- 17 Jan 2023 (actual)
- Study completion
- 29 Jan 2024 (actual)
- First posted
- 24 Nov 2021 (actual)
- Results
- Posted 18 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, randomized, controlled, blinded evaluator, multicenter, between subjects clinical study to identify whether RHA4 is non-inferior to a comparator device for treatment of midface volume deficiency 8 weeks after the last treatment (initial or touch-up).
At Screening, the treating investigator (TI) and the Blinded Live Evaluator (BLE) will evaluate independently the subject's midface using the validated 5-grade Teoxane Midface Volume Deficit Scale (TMVDS) for eligibility of the subject for the study. The BLE will establish a pretreatment score for assessment of effectiveness.
If the assessments of the TI and the BLE are the same or differ exactly by 1 point of the scale, the difference will be considered acceptable. The TI and the BLE need to agree that the subject meets the eligibility criterion (TMVDS grade 2 to 3). If the subject is eligible, the BLE's assessment will be used for the Baseline of the primary endpoint.
Eligible subjects will be enrolled and randomly assigned in a 3:1 ratio at Screening to receive RHA4 or comparator product.
The TI will administer the fillers, and if necessary, subjects will receive a touch-up treatment with the same product that they received on Visit 1, 4 weeks after the initial treatment to optimize the results. If the touch-up treatment is administered, the subject will be asked to come to the site for an additional visit 4 weeks after the touch-up injection.
Subjects will be followed for 52 weeks after their last treatment (initial treatment or touch-up), at which point, they will be offered re-treatment with RHA® 4, regardless of their original treatment, provided that the TI deems the treatment to be appropriate and the subject agrees. Reasons for not administering the re-treatment will be documented.
The subject will then be followed for an additional 12 weeks before exiting the study. If the subject or the TI declines re-treatment, this visit (52 weeks after the last treatment) will be considered the study Exit visit.
For subjects with re-treatment, the Exit visit will be 12 weeks after the re-treatment.
The TI will conduct safety and effectiveness evaluations at each study visit, which will occur: at 4 weeks after the initial and touch-up treatment, 8, 24, and 52 weeks after the last treatment, and after re treatment or until all treatment-related ongoing adverse events (AEs) have resolved or resolved with sequelae as per TI judgment or if follow-up is no longer possible.
A follow-up telephone call for safety will be performed 3 days after each treatment.
Subjects will report their common treatment responses (CTRs) in a subject diary for 30 days after each injection. The diary will also include a list of selected AEs potentially associated with injection of dermal fillers for subjects to report if applicable. All efforts should be made by the TI to schedule the applicable visits to allow completion of the CTR diary.
A BLE will conduct assessments of effectiveness during the study, including assessment of the primary endpoint 8 weeks after the last treatment.
The BLE will be blinded to allocation to groups (RHA4 group or comparator product group).
Furthermore, to ensure that they remain blinded and unbiased when making their assessments throughout the study, the BLE, TI, and subjects will not be allowed to refer to each other's effectiveness assessments. All subjects will be instructed to not discuss their study treatment, AEs, or CTRs with the BLE.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RHA®4 | Experimental | Device: injection of RHA®4 in Midface |
| Comparator Device | Active comparator | Device: injection of Comparator Product in Midface |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Outpatient, male or female of any race, 22 years of age or older
- Female subjects of childbearing potential must have a negative UPT and practice a reliable method of contraception throughout the study.
- Seeking treatment of midface volume deficiency (realistic and achievable as per TI opinion)
- Having midface volume loss of grades 2 to 3 on the TMVDS (ranging from 0 = absent to 4 = very severe). The BLE and TI must independently assess and agree that this criterion is met; however, concordance of fullness is not required. If the assessments of the TI and the BLE are the same or differ by exactly 1 point on the scale, this difference is considered acceptable. If the assessments differ by 2 points or more on the scale, the subject will not be eligible.
- Having cheeks of the same TMVDS grade on the left and right side of the face (i.e., approximate bilateral symmetry)
Key exclusion criteria (6 listed)
- Known hypersensitivity or previous allergic reaction to any component of the study devices.
- Known sensitivity to local anesthetics of the amide type, history of multiple severe allergies, or history of anaphylactic shock.
- History of active chronic debilitating systemic disease that, in the opinion of the investigator, would make the subject a poor candidate in the study.
- History of connective tissue disease.
- Clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability.
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 |
|---|---|---|
| injection of RHA®4 in MidfaceRHA® 4 is a sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus equi bacteria, formulated to a concentration of 23 mg/mL and 0.3% w/w lidocaine in a physiologic buffer. Up to 3.0 mL injected per cheek (subcutaneous and/or supraperiosteal layer). Touch-up treatment provided at 4 weeks (up to 3.0 mL per cheek). | Device | RHA®4 |
| injection of Comparator Product in MidfaceComparator product is sterile, biodegradable, colorless gel of hyaluronic acid generated by Streptococcus species of bacteria, chemically crosslinked with BDDE. Up to 3.0 mL injected per cheek (subcutaneous and/or supraperiosteal layer). Touch-up treatment provided at 4 weeks (up to 3.0 mL per cheek). | Device | Comparator Device |
Primary outcome
Non-inferiority of RHA®4 to the Change From Baseline for Subjects Treated With Comparator Product at 8 Weeks After the Last Treatment as Assessed by the BLE Using the Teoxane Midface Volume Deficit Scale (TMVDS).
Time frame: 8 weeks after the last treatment
A change in the TMVDS ≥1 grade compared to pretreatment will be considered clinically meaningful. In order to confirm sensitivity 8 weeks after the last treatment: the proportion of responders with a ≥1-grade point on the TMVDS scale for Comparator product 8 weeks after the last treatment when compared to Baseline must be ≥70%. The TMVDS is a validated 5-point scale for assessing midface volume deficit. Possible scores range from 0 (Absent) to 4 (Very Severe).
5 secondary outcomes
Change From Baseline in TMVDS Score as Assessed by the BLE at 24 and 52 Weeks After Last Treatment,and Weeks After Re-treatment if Applicable.
Time frame: Week 24, 52 after last treatment, week 12 after re-treatment
Number of Subjects Scored Either "Much Improved" or "Improved" on Global Aesthetic Improvement (GAI) Scale by the BLE.
Time frame: Week 8, 24, 52 after last treatment, week 12 after re-treatment
Subject's Perception of Treatment Effectiveness as Per the "Satisfaction With Cheeks" FACE-Q Scale Questionnaire at Each Visit, at Rest.
Time frame: Change from Baseline at Weeks 8, 24, 52 after last treatment,12 weeks after re-treatment
Subject's Perception of Treatment Effectiveness as Per the "Satisfaction With Cheeks" FACE-Q Scale Questionnaire at Each Visit, When Smiling
Time frame: Change from Baseline at Weeks 8, 24, 52 after last treatment and 12 week after re-treatment.
Number of Subjects "Satisfied" or "Very Satisfied" With Study Treatment Using the Subject Satisfaction Scale at Weeks 8, 24, 52 After Last Treatment and 12 Weeks After Re-treatment.
Time frame: Week 8, 24, 52 after last treatment, week 12 after re-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing injection of RHA®4 in Midface and injection of Comparator Product in Midface in people with Cheek Augmentation and Correction of Age-related Midface Contour Deficiencies, run by Teoxane SA at 1 site 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 8 inclusion and 6 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 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 18 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Non-inferiority of RHA®4 to the Change From Baseline for Subjects Treated With Comparator Product at 8 Weeks After the Last Treatment as Assessed by the BLE Using the Teoxane Midface Volume Deficit Scale (TMVDS). (time frame: 8 weeks after the last treatment). 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 Mar 2025.