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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RHA®4 | Experimental |
| |
| Comparator Device | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| injection of RHA®4 in Midface | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 8 weeks after the last treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Week 24, 52 after last treatment, week 12 after re-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| United States, Massachusetts | Chestnut Hill | Massachusetts | 02467 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | RHA®4 | injection of RHA®4 in Midface: 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). |
| FG001 | Comparator Device | injection of Comparator Product in Midface: 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | RHA®4 | injection of RHA®4 in Midface: 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Primary endpoint on the PP population | Posted | Mean | Standard Deviation | score on a scale | 8 weeks after the last treatment |
|
52 to 64 (for patients receiving re-treatment) weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RHA®4 | injection of RHA®4 in Midface: 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). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COMPLICATIONS FROM HERNIA REPAIR SURGERY | Injury, poisoning and procedural complications | Systematic Assessment | not related to study device or study procedure |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Injection Site Mass | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Scientist | TEOXANE SA | +41(0) 22 344 96 36 | clinical@teoxane.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 12, 2023 | Feb 5, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 13, 2023 | Feb 5, 2025 | SAP_001.pdf |
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Blinded-Live Evaluator
|
| injection of Comparator Product in Midface | Device | 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). |
|
| 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". | 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). | 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). | 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). | Week 8, 24, 52 after last treatment, week 12 after re-treatment |
| BG001 | Comparator Device | injection of Comparator Product in Midface: 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). |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Fitzpatrick Skin Type | Fitzpatrick skin type as determined by the Treating Investigator on the skin tone scale developed to classify skin coloring and response to ultraviolet (UV) radiation. The scale contains 6 grades: I: Pale white skin; Always burns, does not tan. II: Fair skin; Burns easily, tans poorly. III: Darker white skin; Tans after initial burn. IV: Light brown skin; Burns minimally, tans easily. V: Brown skin; Rarely burns, tans darkly easily. VI: Dark brown or black skin; Never burns, always tans darkly. | Count of Participants | Participants |
|
| OG001 | Comparator Device | injection of Comparator Product in Midface: 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). |
|
|
| Secondary | 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). | ITT Population | Posted | Mean | Standard Deviation | score on a scale | Week 24, 52 after last treatment, week 12 after re-treatment |
|
|
|
| Secondary | 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". | ITT Population | Posted | Count of Participants | Participants | Week 8, 24, 52 after last treatment, week 12 after re-treatment |
|
|
|
| Secondary | 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). | ITT population | Posted | Mean | Standard Deviation | score on a scale | Change from Baseline at Weeks 8, 24, 52 after last treatment,12 weeks after re-treatment |
|
|
|
| Secondary | 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). | ITT population | Posted | Mean | Standard Deviation | score on a scale | Change from Baseline at Weeks 8, 24, 52 after last treatment and 12 week after re-treatment. |
|
|
|
| Secondary | 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). | ITT population | Posted | Count of Participants | Participants | Week 8, 24, 52 after last treatment, week 12 after re-treatment |
|
|
|
| 0 |
| 152 |
| 1 |
| 152 |
| 36 |
| 152 |
| EG001 | Comparator Device | injection of Comparator Product in Midface: 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). | 0 | 49 | 3 | 49 | 8 | 49 |
|
| COVID-19 INFECTION | Infections and infestations | Systematic Assessment | Not related to the study device or study procedure |
|
| TRANSIENT ISCHEMIC ATTACK | Nervous system disorders | Systematic Assessment | Not related to the study device or study procedure |
|
| P16 POSITIVE OROPHARYNGEAL CANCER | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment | Not related to the study device or study procedure |
|
| Injection Site Induration | General disorders | Systematic Assessment |
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| Injection Site Pain | General disorders | Systematic Assessment |
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| Injection Site Discoloration | General disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Covid-19 | Infections and infestations | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
|
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| Week 52 after last treatment |
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| Re-treatment: 12 weeks post re-treatment |
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| Week 24 after last treatment |
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| Week 52 after last treatment |
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| Re-treatment: 12 weeks post re-treatment |
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| Week 24 after last treatment |
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| Week 52 after last treatment |
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| Re-treatment: 12 weeks post re-treatment |
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| Week 24 after last treatment |
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| Week 52 after last treatment |
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| Re-treatment: 12 weeks post re-treatment |
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| Week 24 after last treatment |
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| Week 52 after last treatment |
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| Re-treatment: 12 weeks post re-treatment |
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