Moderate to Severe Midface Volume Deficit
Conditions
Brief summary
The clinical investigation is a randomized, subject- and evaluator-blinded, active treatment controlled, multicenter, clinical investigation, to demonstrate the non inferiority of saypha® VOLUME Lidocaine to one of the devices approved for the same indication (Juvéderm® Voluma™ XC).
Detailed description
This will be a multi-center, randomized, double-blind, comparator-controlled study. The study took place in the US at 16 sites. The purpose of the current clinical investigation is to evaluate the effectiveness, safety and long-term safety of saypha® VOLUME Lidocaine for the correction of age-related moderate to severe volume deficit in the midface (augmentation of midface volume deficit), and to demonstrate its non-inferiority to one of the devices approved for the same indication (Juvéderm® Voluma™ XC). In addition, the duration of the aesthetic effect after implantation will be studied. Approximately 486 subjects in total will be randomized and treated resulting in 437 evaluable subjects for the primary endpoint. Randomization will be in a 2:1 ratio (test device: 324, comparator device: 162). Each subject will take part in the investigation for up to 92 weeks. The total anticipated duration of the investigation, from the first-subject-first visit to the last-subject-last-visit, is around 114 weeks, based on expected recruitment period of about 22 weeks.
Interventions
COMBINATION_PRODUCTsaypha® VOLUME Lidocaine
Crosslinked hyaluronic acid (HA) 23 mg/mL + 0.3% lidocaine hydrochloride.
COMBINATION_PRODUCTJuvéderm® Voluma™ XC
Crosslinked HA 20 mg/mL + 0.3% lidocaine hydrochloride
Sponsors
Croma-Pharma GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
(baseline treatment) 1. Male or female subjects aged 22 - 75 years (inclusive) of age at Screening. 2. Subjects with bilateral, approximately symmetric moderate to severe midface volume deficit (severity scores of 2 or 3 on the 5-point Midface Volume Deficit Severity Scale), as assessed by the blinded investigator at the site. 3. Females of childbearing potential must have a negative urine pregnancy test and must agree to use an effective method of birth control throughout the entire study. Male subjects with female partners of child-bearing potential must agree to use contraception throughout the entire study (surgical sterilization or a physical barrier such as a condom). 4. Healthy skin in the midface area and free of diseases that could interfere in cutaneous aging evaluation. 5. Willingness to abstain from any aesthetic or surgical procedures in the treatment area for the duration of entire investigation, including botulinum toxin injection (except glabella or forehead botulinum toxin treatment). 6. Subjects who understand the purpose and conduct of the study and having given written informed consent and are willing and able to attend the study visits as judged by the investigator.
Exclusion criteria
(baseline treatment) 1. Females, who are pregnant and/or, lactating or planning to become pregnant during the clinical investigation 2. History of severe allergies manifested by a history of anaphylaxis or history or presence of multiple severe allergies 3. History of hypersensitivity to hyaluronic acid preparations, lidocaine or any amide-based anesthetic 4. Tendency to keloid formation and/or hypertrophic scars and/ or have pigment disorders 5. Known human immune deficiency virus-positive individuals 6. Presence of infectious, inflammatory or proliferative cancerous or pre-cancerous lesions in the treatment area 7. Re-current (three times a year over the last year) herpes simplex in the treatment area 8. History or presence of any autoimmune or connective tissue disease, or current treatment with immuno-modulating therapy 9. Uncontrolled (or unstable) Diabetes mellitus or systemic diseases as per investigator discretion 10. Previous facial plastic surgery, tissue augmentation with silicone, fat or another non-absorbable substance (permanent fillers) and semi-permanent / long-lasting fillers (e.g., poly-L-lactic acid (PLLA), Polymethylmethacrylate (PMMA) filler) in the area of device application and during the entire investigation 11. Implantation of dermal fillers in the treatment area within the preceding 24 months prior to Visit 1 (Screening) and during the entire investigation 12. Subject has received any of the following aesthetic treatments in the midface area: e.g., laser therapy, absorbable and non-absorbable sutures (threads), dermabrasion, mesotherapy, micro-needling and/or botulinum toxin (including treatment of crow´s feet in the outer eye region) within the last 12 months prior to Visit 1, chemical peeling within the last three months prior to Visit 1 or is planning to undergo such procedures during entire investigation. 13. Facial lipolysis, including submental fat treatments, within the previous 12 months prior to Visit 1 (Screening) and during the entire investigation 14. Bariatric surgery within 12 months prior to Visit 1 (Screening) and during the entire investigation 15. History of bleeding disorder and/or use of anticoagulant, antiplatelet, thrombolytic medication, or anti-inflammatory drugs (oral/injectable corticosteroids or non steroidal anti-inflammatory drugs, e.g., Motrin® or Advil®) or other substances known to increase coagulation time (vitamins or herbal supplements, e.g., St. John's Wort, high doses of vitamin E supplements) from ten days pre- to seven days post injection (baseline treatment and touch-up treatment) 16. Planned dental/oral surgery or modification (bridge-work, implants) within four weeks prior to each injection and to a minimum of four weeks post injection baseline treatment and touch-up treatment 17. Beard longer than three-day beard, or excessive facial hair that could interfere in evaluation of treatment as judged by the investigator 18. Subjects who have one of the following assessments during the visual examinations at Visit 2 (Baseline): Snellen visual acuity test worse than 20/40 (with corrective eyewear, if applicable), abnormal confrontational visual field test, or abnormal ocular motility test. 19. Subjects with active COVID-19 infection and subjects with symptoms consistent with COVID-19 infection including any other respiratory symptoms/illnesses within the past 14 days unless tested negative prior to Visit 1 (Screening) 20. Any medical condition prohibiting the inclusion in the study according to the judgment of the treating investigator 21. Previous enrollment in this clinical investigation 22. Current participation in another clinical trial, or treatment with any investigational drug/medical device within 30 days prior to Visit 1 (Screening) or within five half-lives of an investigational drug, whichever is longer and during the entire investigation 23. Midface volume deficit due to a congenital defect, trauma, or abnormalities in facial adipose tissue distribution such as those associated with HIV related lipodystrophy 24. Subjects who experienced weight change for a minimum of 10% over the last 12 months (e.g., post bariatric patients), or subjects who have the intention to change eating habits that result in a weight gain or loss \>10% during the entire investigation 25. Any individual whose willingness to volunteer in this clinical investigation could be unduly influenced by the expectation, whether justified or not, of benefits associated with participation or of retaliatory response from senior members of a hierarchy in case of refusal to participate (e.g., persons with a legal custodian appointed due to mental disability, prisoners, soldiers and other members of the armed forces, civil servants). 26. Close affiliation with the investigator (e.g., a close relative, financially dependent on the study site) or subject who is an employee of the sponsor's company or group companies of the sponsor. Inclusion criteria: (touch-up treatment) 1\. Females of childbearing potential must have a negative urine pregnancy test
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Week 24 - Per Protocol Dataset | Week 24 | The percentage of responders on the 5-point MVDSS (Mid-Face Volume Deficit Severity Scale where 0 means no deficit and 4 means Extreme Deficit) based on the blinded evaluator´s live assessment at Week 24 after last injection of initial treatment phase compared to the pre-treatment score at Baseline visit. Subjects are defined as responders if they are showing an \>=1 point improvement in MVDSS at Week 24 relative to baseline. |
| The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Week 24 - Full Analysis Dataset | Week 24 | The percentage of responders on the 5-point MVDSS (Mid-Face Volume Deficit Severity Scale where 0 means no deficit and 4 means Extreme Deficit) based on the blinded evaluator´s live assessment at Week 24 after last injection of initial treatment phase compared to the pre-treatment score at Baseline visit. Subjects are defined as responders if they are showing an \>=1 point improvement in MVDSS at Week 24 relative to baseline. Subjects with missing baseline MVDSS score and / or missing MVDSS score at Week 24 after last injection of the initial treatment phase were imputed as non-responders. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Weeks 4, 8, 16, 36, and 48 as Rated by the Blinded Evaluator | Weeks 4, 8, 16, 36, and 48 | The percentage of responders on the 5-point MVDSS (Mid-Face Volume Deficit Severity Scale where 0 means no deficit and 4 means Extreme Deficit), based on the blinded evaluator´s live assessment at Weeks 4, 8, 16, 36, and 48 after last injection of initial treatment compared to the score at Baseline. Subjects are defined as responders if they are showing an \>=1 point improvement in MVDSS at the respective visit relative to baseline. |
| The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Weeks 4, 8, 16, 24, 36, and 48 as Rated by the Independent Blinded Photographic Reviewer | Weeks 4, 8, 16, 24, 36, and 48 | The percentage of responders on the 5-point MVDSS (Mid-Face Volume Deficit Severity Scale where 0 means no deficit and 4 means Extreme Deficit), based on the independent blinded photographic reviewer´s assessment by using photographs at Weeks 4, 8, 16, 24, 36, and 48 after last injection of initial treatment compared to the score at Baseline. The median of all assessments for the same photograph were taken into account. |
| Mean Change in Midface Volume Deficit | Weeks 4, 8, 16, 24, 36, and 48 | Mean change in midface volume deficit measured on the 5-point MVDSS (Mid-Face Volume Deficit Severity Scale where 0 means no deficit and 4 means Extreme Deficit), and based on the blinded evaluator´s live assessment at Weeks 4, 8, 16, 24, 36, and 48 after last injection of initial treatment compared to the score at Baseline. |
| Mean Change in Midface Volume Deficit as Measured by Volumetric Change Measurement | Weeks 4, 8, 16, 24, 36, and 48 | Mean change in midface volume deficit as measured by volumetric change measurement by using 3D digital photographic images at Weeks 4, 8, 16, 24, 36, and 48 after last injection of initial treatment compared to Baseline. |
| Change in Nasolabial Folds Measurements | Weeks 4, 8, 16, 24, 36, and 48 | Shift from baseline in nasolabial folds measured by the 5-point validated NLF-SRS (Nasolabial Folds Severity Rating Scale, where 0 means no NLF and 4 means Extreme Nasolabial fold) based on the blinded evaluator´s live assessment at Weeks 4, 8, 16, 24, 36, and 48 after last injection of initial treatment. |
| Proportion of Subjects With Global Aesthetic Improvement Based on Modified Global Aesthetic Improvement Scale (GAIS) as Rated by Blinded Evaluator | Weeks 4, 8, 16, 24, 36, and 48 | The percentage of subjects with a global aesthetic improvement over baseline (subjects who have been rated as "much improved" or "improved"), based on the blinded evaluator's assessment at Weeks 4, 8, 16, 24, 36, and 48, after last injection of initial treatment phase using the 5-point modified Global Aesthetic Improvement Scale (GAIS). The blinded evaluators assess aesthetic improvement via photographs comparing baseline photos against the respective study visit week photo with the following possible 5 outcomes: "Much worse", "Worse", "No change", "Improved", "Much improved". |
| Proportion of Subjects With Global Aesthetic Improvement Based on Modified Global Aesthetic Improvement Scale (GAIS) as Rated by Subject | Weeks 4, 8, 16, 24, 36, and 48 | The percentage of subjects with a global aesthetic improvement over baseline (subjects who have been rated as "much improved" or "improved"), based on the subject's assessment at Weeks 4, 8, 16, 24, 36, and 48, after last injection of initial treatment phase using the 5-point modified Global Aesthetic Improvement Scale (GAIS). The subjects assess aesthetic improvement via photographs comparing baseline photos against the respective study visit week photo with the following possible 5 outcomes: "Much worse", "Worse", "No change", "Improved", "Much improved". |
| Satisfaction With Outcome Based on FACE-Q(TM) Assessed by Subjects | Weeks 4, 8, 16, 24, 36, and 48 | The extent of subject's satisfaction with overall treatment outcome at Weeks 4, 8, 16, 24, 36, and 48 after last injection of initial treatment phase as assessed by the subject using the Face-Q(TM) Questionnaire "Satisfaction with Outcome". This validated patient reported outcome is based on subject's answers to pre-specified questions with answers ranging as 1="Definitely disagree", 2="Somewhat disagree", 3="Somewhat agree", 4="Definitely agree". The answers are mathematically transferred to one single numerical result between 100 and 0, where 100 reflects the highest possible satisfaction and 0 means the lowest possible satisfaction. |
| Appearance Appraisal Based on FACE-Q(TM) Assessed by Subjects | Weeks 4, 8, 16, 24, 36, and 48 | The extent of subject's appearance appraisal at Weeks 4, 8, 16, 24, 36, and 48 after last injection of initial treatment phase as assessed by the FACE-Q(TM) questionnaire "Satisfaction with Cheeks" compared to Baseline visit (i.e., change from baseline). This validated patient reported outcome is based on subject's answers to pre-specified questions with answers ranging as 1="Very Dissatisfied", 2="Somewhat Dissatisfied", 3="Somewhat Satisfied", 4="Very Satisfied". The answers are mathematically transferred to one single numerical result between 100 and 0, where 100 reflects the highest possible satisfaction and 0 means the lowest possible satisfaction. |
| Pain Assessment by Subjects | Baseline - Immediately after end of treatment and 15, 30, 45, 60 minutes after end of treatment; Week 2 - Immediately after end of treatment and 15, 30, 45, 60 minutes after end of treatment | Assessment of pain associated with the procedure by subjects immediately after injection and about 15, 30, 45 and 60 minutes thereafter for initial treatment at baseline and for touch-up treatment at week 2 (if applicable). Subjects quantified the pain associated with the procedure using a semi-quantitative 11-point Numeric Pain Rating Scale (NPRS): 0 is no pain and 10 is the worst pain you can imagine. Left and right side of the face was assessed separately. |
| Evaluation of Injection Volume | Baseline and Week 2 | Injection volume required to achieve optimal aesthetic result at each treatment (baseline and touch-up treatment together) measured in mL. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORElyse S Rafal, MD
DermResearchCenter of New York
Participant flow
Pre-assignment details
Of 562 enrolled participants, 486 met inclusion criteria and were randomized to treatment.
Participants by arm
| Arm | Count |
|---|---|
| Saypha® VOLUME Lidocaine For injection, either a needle (27G ½'') or cannula (25G 1½) may be used. Randomization will be stratified by injection equipment in a 1:1 ratio.
The volume administered is at the discretion of the treating investigator and depends on the severity of the midface volume deficit to be corrected. However, the maximum volume (left and right side of the midface together) must not exceed 10 mL in total per treatment (initial and repeat-treatment) or 20 mL per 60 kg (130 lbs) body mass per year.
saypha® VOLUME Lidocaine: Crosslinked hyaluronic acid (HA) 23 mg/mL + 0.3% lidocaine hydrochloride. | 322 |
| Juvéderm® Voluma™ XC For injection, either a needle (27G ½'') or cannula (25G 1½) may be used. Randomization will be stratified by injection equipment in a 1:1 ratio.
The volume administered is at the discretion of the treating investigator and depends on the severity of the midface volume deficit to be corrected. However, the maximum volume (left and right side of the midface together) must not exceed 10 mL in total per treatment (initial and repeat-treatment) or 20 mL per 60 kg (130 lbs) body mass per year.
Juvéderm® Voluma™ XC: Crosslinked HA 20 mg/mL + 0.3% lidocaine hydrochloride | 161 |
| Total | 483 |
Baseline characteristics
| Characteristic | Total | Saypha® VOLUME Lidocaine | Juvéderm® Voluma™ XC |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 88 Participants | 59 Participants | 29 Participants |
| Age, Categorical Between 18 and 65 years | 395 Participants | 263 Participants | 132 Participants |
| Age, Continuous | 55.1 years STANDARD_DEVIATION 10.3 | 54.6 years STANDARD_DEVIATION 10.7 | 56.0 years STANDARD_DEVIATION 9.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 96 Participants | 68 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 387 Participants | 254 Participants | 133 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Midface Volume Deficit Severity Scale (MVDSS) by the Blinded Evaluator 0 (none/minimal) | 0 Participants | 0 Participants | 0 Participants |
| Midface Volume Deficit Severity Scale (MVDSS) by the Blinded Evaluator 1 (mild) | 0 Participants | 0 Participants | 0 Participants |
| Midface Volume Deficit Severity Scale (MVDSS) by the Blinded Evaluator 2 (moderate) | 288 Participants | 189 Participants | 99 Participants |
| Midface Volume Deficit Severity Scale (MVDSS) by the Blinded Evaluator 3 (severe) | 195 Participants | 133 Participants | 62 Participants |
| Midface Volume Deficit Severity Scale (MVDSS) by the Blinded Evaluator 4 (very severe) | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 16 Participants | 9 Participants | 7 Participants |
| Race (NIH/OMB) Asian | 12 Participants | 5 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 27 Participants | 20 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 423 Participants | 283 Participants | 140 Participants |
| Region of Enrollment United States | 483 participants | 322 participants | 161 participants |
| Sex: Female, Male Female | 457 Participants | 303 Participants | 154 Participants |
| Sex: Female, Male Male | 26 Participants | 19 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 322 | 0 / 161 | 0 / 192 |
| other Total, other adverse events | 86 / 322 | 41 / 161 | 15 / 192 |
| serious Total, serious adverse events | 4 / 322 | 2 / 161 | 2 / 192 |
Outcome results
Primary
The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Week 24 - Full Analysis Dataset
The percentage of responders on the 5-point MVDSS (Mid-Face Volume Deficit Severity Scale where 0 means no deficit and 4 means Extreme Deficit) based on the blinded evaluator´s live assessment at Week 24 after last injection of initial treatment phase compared to the pre-treatment score at Baseline visit. Subjects are defined as responders if they are showing an \>=1 point improvement in MVDSS at Week 24 relative to baseline. Subjects with missing baseline MVDSS score and / or missing MVDSS score at Week 24 after last injection of the initial treatment phase were imputed as non-responders.
Time frame: Week 24
Population: The population used consists of all randomized subjects, who received at least one administration of the test device or the comparator device. Participants were analyzed as randomized.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Saypha® VOLUME Lidocaine | The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Week 24 - Full Analysis Dataset | 283 Participants |
| Juvéderm® Voluma™ XC | The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Week 24 - Full Analysis Dataset | 135 Participants |
p-value: <0.0001Farrington-Manning test
Primary
The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Week 24 - Per Protocol Dataset
The percentage of responders on the 5-point MVDSS (Mid-Face Volume Deficit Severity Scale where 0 means no deficit and 4 means Extreme Deficit) based on the blinded evaluator´s live assessment at Week 24 after last injection of initial treatment phase compared to the pre-treatment score at Baseline visit. Subjects are defined as responders if they are showing an \>=1 point improvement in MVDSS at Week 24 relative to baseline.
Time frame: Week 24
Population: The population used consists of all randomized subjects, who received at least one administration of the test device or the comparator device and who did not have any major protocol deviation affecting the primary effectiveness endpoint. Subjects with missing baseline Mid-Face Volume Deficit Severity Scale (MVDSS) score and / or missing MVDSS score at Week 24 after last injection of the initial treatment phase were not included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Saypha® VOLUME Lidocaine | The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Week 24 - Per Protocol Dataset | 268 Participants |
| Juvéderm® Voluma™ XC | The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Week 24 - Per Protocol Dataset | 124 Participants |
p-value: <0.0001Farrington-Manning test
Secondary
Appearance Appraisal Based on FACE-Q(TM) Assessed by Subjects
The extent of subject's appearance appraisal at Weeks 4, 8, 16, 24, 36, and 48 after last injection of initial treatment phase as assessed by the FACE-Q(TM) questionnaire Satisfaction with Cheeks compared to Baseline visit (i.e., change from baseline). This validated patient reported outcome is based on subject's answers to pre-specified questions with answers ranging as 1=Very Dissatisfied, 2=Somewhat Dissatisfied, 3=Somewhat Satisfied, 4=Very Satisfied. The answers are mathematically transferred to one single numerical result between 100 and 0, where 100 reflects the highest possible satisfaction and 0 means the lowest possible satisfaction.
Time frame: Weeks 4, 8, 16, 24, 36, and 48
Population: The population used consists of all randomized subjects who received at least one injection with study medication and for whom data are available at the respective timepoint. Participants were analyzed as randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Saypha® VOLUME Lidocaine | Appearance Appraisal Based on FACE-Q(TM) Assessed by Subjects | Week 8 - Change from Baseline | 46.9 score on a scale | Standard Deviation 28.3 |
| Saypha® VOLUME Lidocaine | Appearance Appraisal Based on FACE-Q(TM) Assessed by Subjects | Week 24 - Change from Baseline | 40.2 score on a scale | Standard Deviation 30.3 |
| Saypha® VOLUME Lidocaine | Appearance Appraisal Based on FACE-Q(TM) Assessed by Subjects | Week 36 - Change from Baseline | 35.4 score on a scale | Standard Deviation 30.1 |
| Saypha® VOLUME Lidocaine | Appearance Appraisal Based on FACE-Q(TM) Assessed by Subjects | Week 4 - Change from Baseline | 47.7 score on a scale | Standard Deviation 29.5 |
| Saypha® VOLUME Lidocaine | Appearance Appraisal Based on FACE-Q(TM) Assessed by Subjects | Week 48 - Change from Baseline | 34.7 score on a scale | Standard Deviation 29.3 |
| Saypha® VOLUME Lidocaine | Appearance Appraisal Based on FACE-Q(TM) Assessed by Subjects | Week 16 - Change from Baseline | 42.5 score on a scale | Standard Deviation 30.4 |
| Juvéderm® Voluma™ XC | Appearance Appraisal Based on FACE-Q(TM) Assessed by Subjects | Week 48 - Change from Baseline | 28.7 score on a scale | Standard Deviation 30.2 |
| Juvéderm® Voluma™ XC | Appearance Appraisal Based on FACE-Q(TM) Assessed by Subjects | Week 4 - Change from Baseline | 44.5 score on a scale | Standard Deviation 30 |
| Juvéderm® Voluma™ XC | Appearance Appraisal Based on FACE-Q(TM) Assessed by Subjects | Week 8 - Change from Baseline | 40.4 score on a scale | Standard Deviation 31.3 |
| Juvéderm® Voluma™ XC | Appearance Appraisal Based on FACE-Q(TM) Assessed by Subjects | Week 16 - Change from Baseline | 39.1 score on a scale | Standard Deviation 30.1 |
| Juvéderm® Voluma™ XC | Appearance Appraisal Based on FACE-Q(TM) Assessed by Subjects | Week 36 - Change from Baseline | 32.8 score on a scale | Standard Deviation 30.3 |
| Juvéderm® Voluma™ XC | Appearance Appraisal Based on FACE-Q(TM) Assessed by Subjects | Week 24 - Change from Baseline | 36.8 score on a scale | Standard Deviation 31.4 |
Secondary
Change in Nasolabial Folds Measurements
Shift from baseline in nasolabial folds measured by the 5-point validated NLF-SRS (Nasolabial Folds Severity Rating Scale, where 0 means no NLF and 4 means Extreme Nasolabial fold) based on the blinded evaluator´s live assessment at Weeks 4, 8, 16, 24, 36, and 48 after last injection of initial treatment.
Time frame: Weeks 4, 8, 16, 24, 36, and 48
Population: The population used consists of all randomized subjects, who received at least one administration of the test device or the comparator device and who have data available at the respective visit. Participants were analyzed as randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Saypha® VOLUME Lidocaine | Change in Nasolabial Folds Measurements | Week 48 - Change from Baseline - Right side of the face | -0.3 units on a scale | Standard Deviation 0.8 |
| Saypha® VOLUME Lidocaine | Change in Nasolabial Folds Measurements | Week 24 - Change from Baseline - Left side of the face | -0.5 units on a scale | Standard Deviation 0.8 |
| Saypha® VOLUME Lidocaine | Change in Nasolabial Folds Measurements | Week 8 - Change from Baseline - Right side of the face | -0.5 units on a scale | Standard Deviation 0.9 |
| Saypha® VOLUME Lidocaine | Change in Nasolabial Folds Measurements | Week 24 - Change from Baseline - Right side of the face | -0.4 units on a scale | Standard Deviation 0.8 |
| Saypha® VOLUME Lidocaine | Change in Nasolabial Folds Measurements | Week 4 - Change from Baseline - Right side of the face | -0.5 units on a scale | Standard Deviation 0.8 |
| Saypha® VOLUME Lidocaine | Change in Nasolabial Folds Measurements | Week 36 - Change from Baseline - Left side of the face | -0.4 units on a scale | Standard Deviation 0.8 |
| Saypha® VOLUME Lidocaine | Change in Nasolabial Folds Measurements | Week 16 - Change from Baseline - Left side of the face | -0.5 units on a scale | Standard Deviation 0.8 |
| Saypha® VOLUME Lidocaine | Change in Nasolabial Folds Measurements | Week 36 - Change from Baseline - Right side of the face | -0.3 units on a scale | Standard Deviation 0.8 |
| Saypha® VOLUME Lidocaine | Change in Nasolabial Folds Measurements | Week 4 - Change from Baseline - Left side of the face | -0.5 units on a scale | Standard Deviation 0.8 |
| Saypha® VOLUME Lidocaine | Change in Nasolabial Folds Measurements | Week 48 - Change from Baseline - Left side of the face | -0.4 units on a scale | Standard Deviation 0.7 |
| Saypha® VOLUME Lidocaine | Change in Nasolabial Folds Measurements | Week 16 - Change from Baseline - Right side of the face | -0.4 units on a scale | Standard Deviation 0.8 |
| Saypha® VOLUME Lidocaine | Change in Nasolabial Folds Measurements | Week 8 - Change from Baseline - Left side of the face | -0.5 units on a scale | Standard Deviation 0.8 |
| Juvéderm® Voluma™ XC | Change in Nasolabial Folds Measurements | Week 48 - Change from Baseline - Right side of the face | -0.2 units on a scale | Standard Deviation 0.8 |
| Juvéderm® Voluma™ XC | Change in Nasolabial Folds Measurements | Week 4 - Change from Baseline - Left side of the face | -0.5 units on a scale | Standard Deviation 0.7 |
| Juvéderm® Voluma™ XC | Change in Nasolabial Folds Measurements | Week 4 - Change from Baseline - Right side of the face | -0.5 units on a scale | Standard Deviation 0.7 |
| Juvéderm® Voluma™ XC | Change in Nasolabial Folds Measurements | Week 8 - Change from Baseline - Left side of the face | -0.5 units on a scale | Standard Deviation 0.7 |
| Juvéderm® Voluma™ XC | Change in Nasolabial Folds Measurements | Week 8 - Change from Baseline - Right side of the face | -0.5 units on a scale | Standard Deviation 0.7 |
| Juvéderm® Voluma™ XC | Change in Nasolabial Folds Measurements | Week 16 - Change from Baseline - Left side of the face | -0.5 units on a scale | Standard Deviation 0.8 |
| Juvéderm® Voluma™ XC | Change in Nasolabial Folds Measurements | Week 16 - Change from Baseline - Right side of the face | -0.5 units on a scale | Standard Deviation 0.8 |
| Juvéderm® Voluma™ XC | Change in Nasolabial Folds Measurements | Week 24 - Change from Baseline - Left side of the face | -0.5 units on a scale | Standard Deviation 0.8 |
| Juvéderm® Voluma™ XC | Change in Nasolabial Folds Measurements | Week 24 - Change from Baseline - Right side of the face | -0.5 units on a scale | Standard Deviation 0.8 |
| Juvéderm® Voluma™ XC | Change in Nasolabial Folds Measurements | Week 36 - Change from Baseline - Left side of the face | -0.4 units on a scale | Standard Deviation 0.8 |
| Juvéderm® Voluma™ XC | Change in Nasolabial Folds Measurements | Week 36 - Change from Baseline - Right side of the face | -0.4 units on a scale | Standard Deviation 0.8 |
| Juvéderm® Voluma™ XC | Change in Nasolabial Folds Measurements | Week 48 - Change from Baseline - Left side of the face | -0.3 units on a scale | Standard Deviation 0.8 |
Secondary
Evaluation of Injection Volume
Injection volume required to achieve optimal aesthetic result at each treatment (baseline and touch-up treatment together) measured in mL.
Time frame: Baseline and Week 2
Population: The population used consists of all randomized subjects who received at least one injection with study medication and for whom data are available at the respective timepoint. Participants were analyzed as randomized.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Saypha® VOLUME Lidocaine | Evaluation of Injection Volume | 5.163 mL | Standard Deviation 2.306 |
| Juvéderm® Voluma™ XC | Evaluation of Injection Volume | 4.975 mL | Standard Deviation 2.251 |
Secondary
Mean Change in Midface Volume Deficit
Mean change in midface volume deficit measured on the 5-point MVDSS (Mid-Face Volume Deficit Severity Scale where 0 means no deficit and 4 means Extreme Deficit), and based on the blinded evaluator´s live assessment at Weeks 4, 8, 16, 24, 36, and 48 after last injection of initial treatment compared to the score at Baseline.
Time frame: Weeks 4, 8, 16, 24, 36, and 48
Population: The population used consists of all randomized subjects, who received at least one administration of the test device or the comparator device and who have data available for the respective visit. Participants were analyzed as randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Saypha® VOLUME Lidocaine | Mean Change in Midface Volume Deficit | Week 8 - Change from Baseline | -1.8 score on a scale | Standard Deviation 0.7 |
| Saypha® VOLUME Lidocaine | Mean Change in Midface Volume Deficit | Week 48 - Change from Baseline | -1.0 score on a scale | Standard Deviation 0.8 |
| Saypha® VOLUME Lidocaine | Mean Change in Midface Volume Deficit | Week 16 - Change from Baseline | -1.7 score on a scale | Standard Deviation 0.7 |
| Saypha® VOLUME Lidocaine | Mean Change in Midface Volume Deficit | Week 4 - Change from Baseline | -1.8 score on a scale | Standard Deviation 0.7 |
| Saypha® VOLUME Lidocaine | Mean Change in Midface Volume Deficit | Week 24 - Change from Baseline | -1.6 score on a scale | Standard Deviation 0.7 |
| Saypha® VOLUME Lidocaine | Mean Change in Midface Volume Deficit | Week 36 - Change from Baseline | -1.4 score on a scale | Standard Deviation 0.8 |
| Juvéderm® Voluma™ XC | Mean Change in Midface Volume Deficit | Week 48 - Change from Baseline | -0.9 score on a scale | Standard Deviation 0.8 |
| Juvéderm® Voluma™ XC | Mean Change in Midface Volume Deficit | Week 36 - Change from Baseline | -1.2 score on a scale | Standard Deviation 0.8 |
| Juvéderm® Voluma™ XC | Mean Change in Midface Volume Deficit | Week 4 - Change from Baseline | -1.6 score on a scale | Standard Deviation 0.8 |
| Juvéderm® Voluma™ XC | Mean Change in Midface Volume Deficit | Week 8 - Change from Baseline | -1.6 score on a scale | Standard Deviation 0.8 |
| Juvéderm® Voluma™ XC | Mean Change in Midface Volume Deficit | Week 16 - Change from Baseline | -1.5 score on a scale | Standard Deviation 0.7 |
| Juvéderm® Voluma™ XC | Mean Change in Midface Volume Deficit | Week 24 - Change from Baseline | -1.4 score on a scale | Standard Deviation 0.8 |
Secondary
Mean Change in Midface Volume Deficit as Measured by Volumetric Change Measurement
Mean change in midface volume deficit as measured by volumetric change measurement by using 3D digital photographic images at Weeks 4, 8, 16, 24, 36, and 48 after last injection of initial treatment compared to Baseline.
Time frame: Weeks 4, 8, 16, 24, 36, and 48
Population: The population used consists of all randomized subjects, who received at least one administration of the test device or the comparator device and who have data available at the respective visit. Participants were analyzed as randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Saypha® VOLUME Lidocaine | Mean Change in Midface Volume Deficit as Measured by Volumetric Change Measurement | Week 4 - Change from Baseline [cm^3] | 8.538 cm^3 | Standard Deviation 4.572 |
| Saypha® VOLUME Lidocaine | Mean Change in Midface Volume Deficit as Measured by Volumetric Change Measurement | Week 8 - Change from Baseline [cm^3] | 8.236 cm^3 | Standard Deviation 4.561 |
| Saypha® VOLUME Lidocaine | Mean Change in Midface Volume Deficit as Measured by Volumetric Change Measurement | Week 16 - Change from Baseline [cm^3] | 7.627 cm^3 | Standard Deviation 4.612 |
| Saypha® VOLUME Lidocaine | Mean Change in Midface Volume Deficit as Measured by Volumetric Change Measurement | Week 24 - Change from Baseline [cm^3] | 7.315 cm^3 | Standard Deviation 4.654 |
| Saypha® VOLUME Lidocaine | Mean Change in Midface Volume Deficit as Measured by Volumetric Change Measurement | Week 36 - Change from Baseline [cm^3] | 6.781 cm^3 | Standard Deviation 4.575 |
| Saypha® VOLUME Lidocaine | Mean Change in Midface Volume Deficit as Measured by Volumetric Change Measurement | Week 48 - Change from Baseline [cm^3] | 6.383 cm^3 | Standard Deviation 4.836 |
| Juvéderm® Voluma™ XC | Mean Change in Midface Volume Deficit as Measured by Volumetric Change Measurement | Week 36 - Change from Baseline [cm^3] | 4.739 cm^3 | Standard Deviation 5.106 |
| Juvéderm® Voluma™ XC | Mean Change in Midface Volume Deficit as Measured by Volumetric Change Measurement | Week 4 - Change from Baseline [cm^3] | 6.536 cm^3 | Standard Deviation 4.163 |
| Juvéderm® Voluma™ XC | Mean Change in Midface Volume Deficit as Measured by Volumetric Change Measurement | Week 24 - Change from Baseline [cm^3] | 5.767 cm^3 | Standard Deviation 4.793 |
| Juvéderm® Voluma™ XC | Mean Change in Midface Volume Deficit as Measured by Volumetric Change Measurement | Week 8 - Change from Baseline [cm^3] | 6.711 cm^3 | Standard Deviation 4.341 |
| Juvéderm® Voluma™ XC | Mean Change in Midface Volume Deficit as Measured by Volumetric Change Measurement | Week 48 - Change from Baseline [cm^3] | 4.690 cm^3 | Standard Deviation 5.426 |
| Juvéderm® Voluma™ XC | Mean Change in Midface Volume Deficit as Measured by Volumetric Change Measurement | Week 16 - Change from Baseline [cm^3] | 6.115 cm^3 | Standard Deviation 4.9 |
Secondary
Pain Assessment by Subjects
Assessment of pain associated with the procedure by subjects immediately after injection and about 15, 30, 45 and 60 minutes thereafter for initial treatment at baseline and for touch-up treatment at week 2 (if applicable). Subjects quantified the pain associated with the procedure using a semi-quantitative 11-point Numeric Pain Rating Scale (NPRS): 0 is no pain and 10 is the worst pain you can imagine. Left and right side of the face was assessed separately.
Time frame: Baseline - Immediately after end of treatment and 15, 30, 45, 60 minutes after end of treatment; Week 2 - Immediately after end of treatment and 15, 30, 45, 60 minutes after end of treatment
Population: The population used consists of all randomized subjects who received at least one injection with study medication and for whom data are available at the respective timepoint and side of face. Participants were analyzed as randomized. Participants who received Lidocaine before the assessment were excluded from the analysis for the respective visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Saypha® VOLUME Lidocaine | Pain Assessment by Subjects | Pain assessment 45 minutes after end of treatment - Week 2 - Right | 0.2 score on a scale | Standard Deviation 0.8 |
| Saypha® VOLUME Lidocaine | Pain Assessment by Subjects | Pain assessment immediately after end of treatment - Baseline - Left | 2.5 score on a scale | Standard Deviation 2.3 |
| Saypha® VOLUME Lidocaine | Pain Assessment by Subjects | Pain assessment immediately after end of treatment - Baseline - Right | 2.5 score on a scale | Standard Deviation 2.2 |
| Saypha® VOLUME Lidocaine | Pain Assessment by Subjects | Pain assessment 15 minutes after end of treatment - Baseline - Left | 0.7 score on a scale | Standard Deviation 1.2 |
| Saypha® VOLUME Lidocaine | Pain Assessment by Subjects | Pain assessment 15 minutes after end of treatment - Baseline - Right | 0.8 score on a scale | Standard Deviation 1.3 |
| Saypha® VOLUME Lidocaine | Pain Assessment by Subjects | Pain assessment 30 minutes after end of treatment - Baseline - Left | 0.4 score on a scale | Standard Deviation 0.8 |
| Saypha® VOLUME Lidocaine | Pain Assessment by Subjects | Pain assessment 30 minutes after end of treatment - Baseline - Right | 0.4 score on a scale | Standard Deviation 0.8 |
| Saypha® VOLUME Lidocaine | Pain Assessment by Subjects | Pain assessment 45 minutes after end of treatment - Baseline - Left | 0.2 score on a scale | Standard Deviation 0.6 |
| Saypha® VOLUME Lidocaine | Pain Assessment by Subjects | Pain assessment 45 minutes after end of treatment - Baseline - Right | 0.2 score on a scale | Standard Deviation 0.6 |
| Saypha® VOLUME Lidocaine | Pain Assessment by Subjects | Pain assessment 60 minutes after end of treatment - Baseline - Left | 0.1 score on a scale | Standard Deviation 0.4 |
| Saypha® VOLUME Lidocaine | Pain Assessment by Subjects | Pain assessment 60 minutes after end of treatment - Baseline - Right | 0.1 score on a scale | Standard Deviation 0.4 |
| Saypha® VOLUME Lidocaine | Pain Assessment by Subjects | Pain assessment immediately after end of treatment - Week 2 - Left | 2.0 score on a scale | Standard Deviation 2.5 |
| Saypha® VOLUME Lidocaine | Pain Assessment by Subjects | Pain assessment immediately after end of treatment - Week 2 - Right | 1.9 score on a scale | Standard Deviation 2.4 |
| Saypha® VOLUME Lidocaine | Pain Assessment by Subjects | Pain assessment 15 minutes after end of treatment - Week 2 - Left | 0.7 score on a scale | Standard Deviation 1.4 |
| Saypha® VOLUME Lidocaine | Pain Assessment by Subjects | Pain assessment 15 minutes after end of treatment - Week 2 - Right | 0.6 score on a scale | Standard Deviation 1.4 |
| Saypha® VOLUME Lidocaine | Pain Assessment by Subjects | Pain assessment 30 minutes after end of treatment - Week 2 - Left | 0.4 score on a scale | Standard Deviation 1 |
| Saypha® VOLUME Lidocaine | Pain Assessment by Subjects | Pain assessment 30 minutes after end of treatment - Week 2 - Right | 0.4 score on a scale | Standard Deviation 1 |
| Saypha® VOLUME Lidocaine | Pain Assessment by Subjects | Pain assessment 45 minutes after end of treatment - Week 2 - Left | 0.2 score on a scale | Standard Deviation 0.8 |
| Saypha® VOLUME Lidocaine | Pain Assessment by Subjects | Pain assessment 60 minutes after end of treatment - Week 2 - Left | 0.1 score on a scale | Standard Deviation 0.7 |
| Saypha® VOLUME Lidocaine | Pain Assessment by Subjects | Pain assessment 60 minutes after end of treatment - Week 2 - Right | 0.1 score on a scale | Standard Deviation 0.7 |
| Juvéderm® Voluma™ XC | Pain Assessment by Subjects | Pain assessment 45 minutes after end of treatment - Week 2 - Left | 0.2 score on a scale | Standard Deviation 0.6 |
| Juvéderm® Voluma™ XC | Pain Assessment by Subjects | Pain assessment 45 minutes after end of treatment - Week 2 - Right | 0.2 score on a scale | Standard Deviation 0.6 |
| Juvéderm® Voluma™ XC | Pain Assessment by Subjects | Pain assessment 60 minutes after end of treatment - Baseline - Right | 0.2 score on a scale | Standard Deviation 0.5 |
| Juvéderm® Voluma™ XC | Pain Assessment by Subjects | Pain assessment immediately after end of treatment - Baseline - Left | 2.3 score on a scale | Standard Deviation 2.2 |
| Juvéderm® Voluma™ XC | Pain Assessment by Subjects | Pain assessment 30 minutes after end of treatment - Week 2 - Left | 0.3 score on a scale | Standard Deviation 0.8 |
| Juvéderm® Voluma™ XC | Pain Assessment by Subjects | Pain assessment immediately after end of treatment - Baseline - Right | 2.3 score on a scale | Standard Deviation 2.3 |
| Juvéderm® Voluma™ XC | Pain Assessment by Subjects | Pain assessment immediately after end of treatment - Week 2 - Left | 1.8 score on a scale | Standard Deviation 2.1 |
| Juvéderm® Voluma™ XC | Pain Assessment by Subjects | Pain assessment 15 minutes after end of treatment - Baseline - Left | 0.8 score on a scale | Standard Deviation 1.3 |
| Juvéderm® Voluma™ XC | Pain Assessment by Subjects | Pain assessment 60 minutes after end of treatment - Week 2 - Right | 0.1 score on a scale | Standard Deviation 0.5 |
| Juvéderm® Voluma™ XC | Pain Assessment by Subjects | Pain assessment 15 minutes after end of treatment - Baseline - Right | 0.8 score on a scale | Standard Deviation 1.4 |
| Juvéderm® Voluma™ XC | Pain Assessment by Subjects | Pain assessment immediately after end of treatment - Week 2 - Right | 1.9 score on a scale | Standard Deviation 2.1 |
| Juvéderm® Voluma™ XC | Pain Assessment by Subjects | Pain assessment 30 minutes after end of treatment - Baseline - Left | 0.6 score on a scale | Standard Deviation 1 |
| Juvéderm® Voluma™ XC | Pain Assessment by Subjects | Pain assessment 30 minutes after end of treatment - Week 2 - Right | 0.3 score on a scale | Standard Deviation 0.8 |
| Juvéderm® Voluma™ XC | Pain Assessment by Subjects | Pain assessment 30 minutes after end of treatment - Baseline - Right | 0.6 score on a scale | Standard Deviation 1 |
| Juvéderm® Voluma™ XC | Pain Assessment by Subjects | Pain assessment 15 minutes after end of treatment - Week 2 - Left | 0.6 score on a scale | Standard Deviation 1.2 |
| Juvéderm® Voluma™ XC | Pain Assessment by Subjects | Pain assessment 45 minutes after end of treatment - Baseline - Left | 0.4 score on a scale | Standard Deviation 0.9 |
| Juvéderm® Voluma™ XC | Pain Assessment by Subjects | Pain assessment 60 minutes after end of treatment - Week 2 - Left | 0.1 score on a scale | Standard Deviation 0.5 |
| Juvéderm® Voluma™ XC | Pain Assessment by Subjects | Pain assessment 45 minutes after end of treatment - Baseline - Right | 0.4 score on a scale | Standard Deviation 0.9 |
| Juvéderm® Voluma™ XC | Pain Assessment by Subjects | Pain assessment 15 minutes after end of treatment - Week 2 - Right | 0.7 score on a scale | Standard Deviation 1.2 |
| Juvéderm® Voluma™ XC | Pain Assessment by Subjects | Pain assessment 60 minutes after end of treatment - Baseline - Left | 0.2 score on a scale | Standard Deviation 0.6 |
Secondary
Proportion of Subjects With Global Aesthetic Improvement Based on Modified Global Aesthetic Improvement Scale (GAIS) as Rated by Blinded Evaluator
The percentage of subjects with a global aesthetic improvement over baseline (subjects who have been rated as much improved or improved), based on the blinded evaluator's assessment at Weeks 4, 8, 16, 24, 36, and 48, after last injection of initial treatment phase using the 5-point modified Global Aesthetic Improvement Scale (GAIS). The blinded evaluators assess aesthetic improvement via photographs comparing baseline photos against the respective study visit week photo with the following possible 5 outcomes: Much worse, Worse, No change, Improved, Much improved.
Time frame: Weeks 4, 8, 16, 24, 36, and 48
Population: The population used consists of all randomized subjects who received at least one injection with study medication and for whom data are available at the respective timepoint. Participants were analyzed as randomized.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Saypha® VOLUME Lidocaine | Proportion of Subjects With Global Aesthetic Improvement Based on Modified Global Aesthetic Improvement Scale (GAIS) as Rated by Blinded Evaluator | Week 4 | 292 Participants |
| Saypha® VOLUME Lidocaine | Proportion of Subjects With Global Aesthetic Improvement Based on Modified Global Aesthetic Improvement Scale (GAIS) as Rated by Blinded Evaluator | Week 8 | 298 Participants |
| Saypha® VOLUME Lidocaine | Proportion of Subjects With Global Aesthetic Improvement Based on Modified Global Aesthetic Improvement Scale (GAIS) as Rated by Blinded Evaluator | Week 16 | 287 Participants |
| Saypha® VOLUME Lidocaine | Proportion of Subjects With Global Aesthetic Improvement Based on Modified Global Aesthetic Improvement Scale (GAIS) as Rated by Blinded Evaluator | Week 24 | 283 Participants |
| Saypha® VOLUME Lidocaine | Proportion of Subjects With Global Aesthetic Improvement Based on Modified Global Aesthetic Improvement Scale (GAIS) as Rated by Blinded Evaluator | Week 36 | 261 Participants |
| Saypha® VOLUME Lidocaine | Proportion of Subjects With Global Aesthetic Improvement Based on Modified Global Aesthetic Improvement Scale (GAIS) as Rated by Blinded Evaluator | Week 48 | 237 Participants |
| Juvéderm® Voluma™ XC | Proportion of Subjects With Global Aesthetic Improvement Based on Modified Global Aesthetic Improvement Scale (GAIS) as Rated by Blinded Evaluator | Week 36 | 126 Participants |
| Juvéderm® Voluma™ XC | Proportion of Subjects With Global Aesthetic Improvement Based on Modified Global Aesthetic Improvement Scale (GAIS) as Rated by Blinded Evaluator | Week 4 | 150 Participants |
| Juvéderm® Voluma™ XC | Proportion of Subjects With Global Aesthetic Improvement Based on Modified Global Aesthetic Improvement Scale (GAIS) as Rated by Blinded Evaluator | Week 24 | 135 Participants |
| Juvéderm® Voluma™ XC | Proportion of Subjects With Global Aesthetic Improvement Based on Modified Global Aesthetic Improvement Scale (GAIS) as Rated by Blinded Evaluator | Week 8 | 149 Participants |
| Juvéderm® Voluma™ XC | Proportion of Subjects With Global Aesthetic Improvement Based on Modified Global Aesthetic Improvement Scale (GAIS) as Rated by Blinded Evaluator | Week 48 | 105 Participants |
| Juvéderm® Voluma™ XC | Proportion of Subjects With Global Aesthetic Improvement Based on Modified Global Aesthetic Improvement Scale (GAIS) as Rated by Blinded Evaluator | Week 16 | 149 Participants |
Secondary
Proportion of Subjects With Global Aesthetic Improvement Based on Modified Global Aesthetic Improvement Scale (GAIS) as Rated by Subject
The percentage of subjects with a global aesthetic improvement over baseline (subjects who have been rated as much improved or improved), based on the subject's assessment at Weeks 4, 8, 16, 24, 36, and 48, after last injection of initial treatment phase using the 5-point modified Global Aesthetic Improvement Scale (GAIS). The subjects assess aesthetic improvement via photographs comparing baseline photos against the respective study visit week photo with the following possible 5 outcomes: Much worse, Worse, No change, Improved, Much improved.
Time frame: Weeks 4, 8, 16, 24, 36, and 48
Population: The population used consists of all randomized subjects who received at least one injection with study medication and for whom data are available at the respective timepoint. Participants were analyzed as randomized.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Saypha® VOLUME Lidocaine | Proportion of Subjects With Global Aesthetic Improvement Based on Modified Global Aesthetic Improvement Scale (GAIS) as Rated by Subject | Week 4 | 283 Participants |
| Saypha® VOLUME Lidocaine | Proportion of Subjects With Global Aesthetic Improvement Based on Modified Global Aesthetic Improvement Scale (GAIS) as Rated by Subject | Week 8 | 281 Participants |
| Saypha® VOLUME Lidocaine | Proportion of Subjects With Global Aesthetic Improvement Based on Modified Global Aesthetic Improvement Scale (GAIS) as Rated by Subject | Week 16 | 269 Participants |
| Saypha® VOLUME Lidocaine | Proportion of Subjects With Global Aesthetic Improvement Based on Modified Global Aesthetic Improvement Scale (GAIS) as Rated by Subject | Week 24 | 255 Participants |
| Saypha® VOLUME Lidocaine | Proportion of Subjects With Global Aesthetic Improvement Based on Modified Global Aesthetic Improvement Scale (GAIS) as Rated by Subject | Week 36 | 219 Participants |
| Saypha® VOLUME Lidocaine | Proportion of Subjects With Global Aesthetic Improvement Based on Modified Global Aesthetic Improvement Scale (GAIS) as Rated by Subject | Week 48 | 213 Participants |
| Juvéderm® Voluma™ XC | Proportion of Subjects With Global Aesthetic Improvement Based on Modified Global Aesthetic Improvement Scale (GAIS) as Rated by Subject | Week 36 | 120 Participants |
| Juvéderm® Voluma™ XC | Proportion of Subjects With Global Aesthetic Improvement Based on Modified Global Aesthetic Improvement Scale (GAIS) as Rated by Subject | Week 4 | 146 Participants |
| Juvéderm® Voluma™ XC | Proportion of Subjects With Global Aesthetic Improvement Based on Modified Global Aesthetic Improvement Scale (GAIS) as Rated by Subject | Week 24 | 125 Participants |
| Juvéderm® Voluma™ XC | Proportion of Subjects With Global Aesthetic Improvement Based on Modified Global Aesthetic Improvement Scale (GAIS) as Rated by Subject | Week 8 | 142 Participants |
| Juvéderm® Voluma™ XC | Proportion of Subjects With Global Aesthetic Improvement Based on Modified Global Aesthetic Improvement Scale (GAIS) as Rated by Subject | Week 48 | 99 Participants |
| Juvéderm® Voluma™ XC | Proportion of Subjects With Global Aesthetic Improvement Based on Modified Global Aesthetic Improvement Scale (GAIS) as Rated by Subject | Week 16 | 137 Participants |
Secondary
Satisfaction With Outcome Based on FACE-Q(TM) Assessed by Subjects
The extent of subject's satisfaction with overall treatment outcome at Weeks 4, 8, 16, 24, 36, and 48 after last injection of initial treatment phase as assessed by the subject using the Face-Q(TM) Questionnaire Satisfaction with Outcome. This validated patient reported outcome is based on subject's answers to pre-specified questions with answers ranging as 1=Definitely disagree, 2=Somewhat disagree, 3=Somewhat agree, 4=Definitely agree. The answers are mathematically transferred to one single numerical result between 100 and 0, where 100 reflects the highest possible satisfaction and 0 means the lowest possible satisfaction.
Time frame: Weeks 4, 8, 16, 24, 36, and 48
Population: The population used consists of all randomized subjects who received at least one injection with study medication and for whom data are available at the respective timepoint. Participants were analyzed as randomized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Saypha® VOLUME Lidocaine | Satisfaction With Outcome Based on FACE-Q(TM) Assessed by Subjects | Week 4 | 73.2 score on a scale | Standard Deviation 20.6 |
| Saypha® VOLUME Lidocaine | Satisfaction With Outcome Based on FACE-Q(TM) Assessed by Subjects | Week 8 | 72.1 score on a scale | Standard Deviation 23 |
| Saypha® VOLUME Lidocaine | Satisfaction With Outcome Based on FACE-Q(TM) Assessed by Subjects | Week 16 | 68.6 score on a scale | Standard Deviation 23.1 |
| Saypha® VOLUME Lidocaine | Satisfaction With Outcome Based on FACE-Q(TM) Assessed by Subjects | Week 24 | 68.2 score on a scale | Standard Deviation 23.4 |
| Saypha® VOLUME Lidocaine | Satisfaction With Outcome Based on FACE-Q(TM) Assessed by Subjects | Week 36 | 63.7 score on a scale | Standard Deviation 24.5 |
| Saypha® VOLUME Lidocaine | Satisfaction With Outcome Based on FACE-Q(TM) Assessed by Subjects | Week 48 | 63.5 score on a scale | Standard Deviation 24.3 |
| Juvéderm® Voluma™ XC | Satisfaction With Outcome Based on FACE-Q(TM) Assessed by Subjects | Week 36 | 64.5 score on a scale | Standard Deviation 24.7 |
| Juvéderm® Voluma™ XC | Satisfaction With Outcome Based on FACE-Q(TM) Assessed by Subjects | Week 4 | 72.6 score on a scale | Standard Deviation 21.1 |
| Juvéderm® Voluma™ XC | Satisfaction With Outcome Based on FACE-Q(TM) Assessed by Subjects | Week 24 | 68.4 score on a scale | Standard Deviation 22.6 |
| Juvéderm® Voluma™ XC | Satisfaction With Outcome Based on FACE-Q(TM) Assessed by Subjects | Week 8 | 70.5 score on a scale | Standard Deviation 22.7 |
| Juvéderm® Voluma™ XC | Satisfaction With Outcome Based on FACE-Q(TM) Assessed by Subjects | Week 48 | 62.1 score on a scale | Standard Deviation 24.6 |
| Juvéderm® Voluma™ XC | Satisfaction With Outcome Based on FACE-Q(TM) Assessed by Subjects | Week 16 | 68.7 score on a scale | Standard Deviation 21.6 |
Secondary
The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Weeks 4, 8, 16, 24, 36, and 48 as Rated by the Independent Blinded Photographic Reviewer
The percentage of responders on the 5-point MVDSS (Mid-Face Volume Deficit Severity Scale where 0 means no deficit and 4 means Extreme Deficit), based on the independent blinded photographic reviewer´s assessment by using photographs at Weeks 4, 8, 16, 24, 36, and 48 after last injection of initial treatment compared to the score at Baseline. The median of all assessments for the same photograph were taken into account.
Time frame: Weeks 4, 8, 16, 24, 36, and 48
Population: The population used consists of all randomized subjects, who received at least one administration of the test device or the comparator device and who have data available for the respective visit. Participants were analyzed as randomized.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Saypha® VOLUME Lidocaine | The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Weeks 4, 8, 16, 24, 36, and 48 as Rated by the Independent Blinded Photographic Reviewer | Week 4 | 162 Participants |
| Saypha® VOLUME Lidocaine | The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Weeks 4, 8, 16, 24, 36, and 48 as Rated by the Independent Blinded Photographic Reviewer | Week 8 | 173 Participants |
| Saypha® VOLUME Lidocaine | The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Weeks 4, 8, 16, 24, 36, and 48 as Rated by the Independent Blinded Photographic Reviewer | Week 16 | 170 Participants |
| Saypha® VOLUME Lidocaine | The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Weeks 4, 8, 16, 24, 36, and 48 as Rated by the Independent Blinded Photographic Reviewer | Week 24 | 163 Participants |
| Saypha® VOLUME Lidocaine | The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Weeks 4, 8, 16, 24, 36, and 48 as Rated by the Independent Blinded Photographic Reviewer | Week 36 | 156 Participants |
| Saypha® VOLUME Lidocaine | The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Weeks 4, 8, 16, 24, 36, and 48 as Rated by the Independent Blinded Photographic Reviewer | Week 48 | 147 Participants |
| Juvéderm® Voluma™ XC | The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Weeks 4, 8, 16, 24, 36, and 48 as Rated by the Independent Blinded Photographic Reviewer | Week 36 | 67 Participants |
| Juvéderm® Voluma™ XC | The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Weeks 4, 8, 16, 24, 36, and 48 as Rated by the Independent Blinded Photographic Reviewer | Week 4 | 78 Participants |
| Juvéderm® Voluma™ XC | The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Weeks 4, 8, 16, 24, 36, and 48 as Rated by the Independent Blinded Photographic Reviewer | Week 24 | 77 Participants |
| Juvéderm® Voluma™ XC | The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Weeks 4, 8, 16, 24, 36, and 48 as Rated by the Independent Blinded Photographic Reviewer | Week 8 | 83 Participants |
| Juvéderm® Voluma™ XC | The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Weeks 4, 8, 16, 24, 36, and 48 as Rated by the Independent Blinded Photographic Reviewer | Week 48 | 67 Participants |
| Juvéderm® Voluma™ XC | The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Weeks 4, 8, 16, 24, 36, and 48 as Rated by the Independent Blinded Photographic Reviewer | Week 16 | 85 Participants |
Secondary
The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Weeks 4, 8, 16, 36, and 48 as Rated by the Blinded Evaluator
The percentage of responders on the 5-point MVDSS (Mid-Face Volume Deficit Severity Scale where 0 means no deficit and 4 means Extreme Deficit), based on the blinded evaluator´s live assessment at Weeks 4, 8, 16, 36, and 48 after last injection of initial treatment compared to the score at Baseline. Subjects are defined as responders if they are showing an \>=1 point improvement in MVDSS at the respective visit relative to baseline.
Time frame: Weeks 4, 8, 16, 36, and 48
Population: The population used consists of all randomized subjects, who received at least one administration of the test device or the comparator device and have data available for the respective visit. Participants were analyzed as randomized.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Saypha® VOLUME Lidocaine | The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Weeks 4, 8, 16, 36, and 48 as Rated by the Blinded Evaluator | Week 8 | 294 Participants |
| Saypha® VOLUME Lidocaine | The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Weeks 4, 8, 16, 36, and 48 as Rated by the Blinded Evaluator | Week 36 | 254 Participants |
| Saypha® VOLUME Lidocaine | The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Weeks 4, 8, 16, 36, and 48 as Rated by the Blinded Evaluator | Week 4 | 291 Participants |
| Saypha® VOLUME Lidocaine | The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Weeks 4, 8, 16, 36, and 48 as Rated by the Blinded Evaluator | Week 48 | 203 Participants |
| Saypha® VOLUME Lidocaine | The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Weeks 4, 8, 16, 36, and 48 as Rated by the Blinded Evaluator | Week 16 | 286 Participants |
| Juvéderm® Voluma™ XC | The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Weeks 4, 8, 16, 36, and 48 as Rated by the Blinded Evaluator | Week 48 | 90 Participants |
| Juvéderm® Voluma™ XC | The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Weeks 4, 8, 16, 36, and 48 as Rated by the Blinded Evaluator | Week 4 | 149 Participants |
| Juvéderm® Voluma™ XC | The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Weeks 4, 8, 16, 36, and 48 as Rated by the Blinded Evaluator | Week 8 | 147 Participants |
| Juvéderm® Voluma™ XC | The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Weeks 4, 8, 16, 36, and 48 as Rated by the Blinded Evaluator | Week 16 | 147 Participants |
| Juvéderm® Voluma™ XC | The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Weeks 4, 8, 16, 36, and 48 as Rated by the Blinded Evaluator | Week 36 | 115 Participants |