Trial Outcomes & Findings for Saypha® VOLUME Lidocaine for Midface Augmentation (NCT NCT05386030)
NCT ID: NCT05386030
Last Updated: 2025-01-16
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
562 participants
Primary outcome timeframe
Week 24
Results posted on
2025-01-16
Participant Flow
Of 562 enrolled participants, 486 met inclusion criteria and were randomized to treatment.
Participant milestones
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
324
|
162
|
|
Overall Study
Received Treatment
|
322
|
161
|
|
Overall Study
COMPLETED
|
280
|
143
|
|
Overall Study
NOT COMPLETED
|
44
|
19
|
Reasons for withdrawal
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Physician Decision
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
19
|
7
|
|
Overall Study
Withdrawal by Subject
|
20
|
10
|
|
Overall Study
Eligibility criteria violation
|
1
|
1
|
|
Overall Study
Personal Reasons
|
1
|
0
|
Baseline Characteristics
Saypha® VOLUME Lidocaine for Midface Augmentation
Baseline characteristics by cohort
| Measure |
Saypha® VOLUME Lidocaine
n=322 Participants
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.
|
Juvéderm® Voluma™ XC
n=161 Participants
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
|
Total
n=483 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
263 Participants
n=5 Participants
|
132 Participants
n=7 Participants
|
395 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
59 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Age, Continuous
|
54.6 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
56.0 years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
55.1 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
303 Participants
n=5 Participants
|
154 Participants
n=7 Participants
|
457 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
68 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
254 Participants
n=5 Participants
|
133 Participants
n=7 Participants
|
387 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
283 Participants
n=5 Participants
|
140 Participants
n=7 Participants
|
423 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
322 participants
n=5 Participants
|
161 participants
n=7 Participants
|
483 participants
n=5 Participants
|
|
Midface Volume Deficit Severity Scale (MVDSS) by the Blinded Evaluator
0 (none/minimal)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Midface Volume Deficit Severity Scale (MVDSS) by the Blinded Evaluator
1 (mild)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Midface Volume Deficit Severity Scale (MVDSS) by the Blinded Evaluator
2 (moderate)
|
189 Participants
n=5 Participants
|
99 Participants
n=7 Participants
|
288 Participants
n=5 Participants
|
|
Midface Volume Deficit Severity Scale (MVDSS) by the Blinded Evaluator
3 (severe)
|
133 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
195 Participants
n=5 Participants
|
|
Midface Volume Deficit Severity Scale (MVDSS) by the Blinded Evaluator
4 (very severe)
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: 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.
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.
Outcome measures
| Measure |
Saypha® VOLUME Lidocaine
n=275 Participants
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.
|
Juvéderm® Voluma™ XC
n=139 Participants
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
|
|---|---|---|
|
The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Week 24 - Per Protocol Dataset
|
268 Participants
|
124 Participants
|
PRIMARY outcome
Timeframe: Week 24Population: 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.
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.
Outcome measures
| Measure |
Saypha® VOLUME Lidocaine
n=322 Participants
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.
|
Juvéderm® Voluma™ XC
n=161 Participants
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
|
|---|---|---|
|
The Percentage of Responders on the 5-point Mid-Face Volume Deficit Severity Scale (MVDSS) at Week 24 - Full Analysis Dataset
|
283 Participants
|
135 Participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 16, 36, and 48Population: 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.
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.
Outcome measures
| Measure |
Saypha® VOLUME Lidocaine
n=322 Participants
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.
|
Juvéderm® Voluma™ XC
n=161 Participants
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
|
|---|---|---|
|
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
|
147 Participants
|
|
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
|
115 Participants
|
|
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
|
149 Participants
|
|
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
|
147 Participants
|
|
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
|
90 Participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 16, 24, 36, and 48Population: 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.
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.
Outcome measures
| Measure |
Saypha® VOLUME Lidocaine
n=322 Participants
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.
|
Juvéderm® Voluma™ XC
n=161 Participants
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
|
|---|---|---|
|
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
|
83 Participants
|
|
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
|
67 Participants
|
|
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
|
67 Participants
|
|
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
|
78 Participants
|
|
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
|
85 Participants
|
|
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
|
77 Participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 16, 24, 36, and 48Population: 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.
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.
Outcome measures
| Measure |
Saypha® VOLUME Lidocaine
n=322 Participants
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.
|
Juvéderm® Voluma™ XC
n=161 Participants
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
|
|---|---|---|
|
Mean Change in Midface Volume Deficit
Week 4 - Change from Baseline
|
-1.8 score on a scale
Standard Deviation 0.7
|
-1.6 score on a scale
Standard Deviation 0.8
|
|
Mean Change in Midface Volume Deficit
Week 8 - Change from Baseline
|
-1.8 score on a scale
Standard Deviation 0.7
|
-1.6 score on a scale
Standard Deviation 0.8
|
|
Mean Change in Midface Volume Deficit
Week 16 - Change from Baseline
|
-1.7 score on a scale
Standard Deviation 0.7
|
-1.5 score on a scale
Standard Deviation 0.7
|
|
Mean Change in Midface Volume Deficit
Week 24 - Change from Baseline
|
-1.6 score on a scale
Standard Deviation 0.7
|
-1.4 score on a scale
Standard Deviation 0.8
|
|
Mean Change in Midface Volume Deficit
Week 36 - Change from Baseline
|
-1.4 score on a scale
Standard Deviation 0.8
|
-1.2 score on a scale
Standard Deviation 0.8
|
|
Mean Change in Midface Volume Deficit
Week 48 - Change from Baseline
|
-1.0 score on a scale
Standard Deviation 0.8
|
-0.9 score on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 16, 24, 36, and 48Population: 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.
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.
Outcome measures
| Measure |
Saypha® VOLUME Lidocaine
n=322 Participants
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.
|
Juvéderm® Voluma™ XC
n=161 Participants
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
|
|---|---|---|
|
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
|
6.711 cm^3
Standard Deviation 4.341
|
|
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
|
6.115 cm^3
Standard Deviation 4.900
|
|
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
|
6.536 cm^3
Standard Deviation 4.163
|
|
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
|
5.767 cm^3
Standard Deviation 4.793
|
|
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
|
4.739 cm^3
Standard Deviation 5.106
|
|
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
|
4.690 cm^3
Standard Deviation 5.426
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 16, 24, 36, and 48Population: 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.
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.
Outcome measures
| Measure |
Saypha® VOLUME Lidocaine
n=322 Participants
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.
|
Juvéderm® Voluma™ XC
n=161 Participants
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
|
|---|---|---|
|
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
|
-0.3 units on a scale
Standard Deviation 0.8
|
|
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
|
-0.5 units on a scale
Standard Deviation 0.7
|
|
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
|
-0.5 units on a scale
Standard Deviation 0.7
|
|
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
|
-0.5 units on a scale
Standard Deviation 0.7
|
|
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
|
-0.5 units on a scale
Standard Deviation 0.7
|
|
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
|
-0.5 units on a scale
Standard Deviation 0.8
|
|
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
|
-0.5 units on a scale
Standard Deviation 0.8
|
|
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
|
-0.5 units on a scale
Standard Deviation 0.8
|
|
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
|
-0.5 units on a scale
Standard Deviation 0.8
|
|
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
|
-0.4 units on a scale
Standard Deviation 0.8
|
|
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
|
-0.4 units on a scale
Standard Deviation 0.8
|
|
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
|
-0.2 units on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 16, 24, 36, and 48Population: 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.
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".
Outcome measures
| Measure |
Saypha® VOLUME Lidocaine
n=322 Participants
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.
|
Juvéderm® Voluma™ XC
n=161 Participants
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
|
|---|---|---|
|
Proportion of Subjects With Global Aesthetic Improvement Based on Modified Global Aesthetic Improvement Scale (GAIS) as Rated by Blinded Evaluator
Week 16
|
287 Participants
|
149 Participants
|
|
Proportion of Subjects With Global Aesthetic Improvement Based on Modified Global Aesthetic Improvement Scale (GAIS) as Rated by Blinded Evaluator
Week 24
|
283 Participants
|
135 Participants
|
|
Proportion of Subjects With Global Aesthetic Improvement Based on Modified Global Aesthetic Improvement Scale (GAIS) as Rated by Blinded Evaluator
Week 36
|
261 Participants
|
126 Participants
|
|
Proportion of Subjects With Global Aesthetic Improvement Based on Modified Global Aesthetic Improvement Scale (GAIS) as Rated by Blinded Evaluator
Week 48
|
237 Participants
|
105 Participants
|
|
Proportion of Subjects With Global Aesthetic Improvement Based on Modified Global Aesthetic Improvement Scale (GAIS) as Rated by Blinded Evaluator
Week 4
|
292 Participants
|
150 Participants
|
|
Proportion of Subjects With Global Aesthetic Improvement Based on Modified Global Aesthetic Improvement Scale (GAIS) as Rated by Blinded Evaluator
Week 8
|
298 Participants
|
149 Participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 16, 24, 36, and 48Population: 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.
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".
Outcome measures
| Measure |
Saypha® VOLUME Lidocaine
n=322 Participants
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.
|
Juvéderm® Voluma™ XC
n=161 Participants
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
|
|---|---|---|
|
Proportion of Subjects With Global Aesthetic Improvement Based on Modified Global Aesthetic Improvement Scale (GAIS) as Rated by Subject
Week 16
|
269 Participants
|
137 Participants
|
|
Proportion of Subjects With Global Aesthetic Improvement Based on Modified Global Aesthetic Improvement Scale (GAIS) as Rated by Subject
Week 24
|
255 Participants
|
125 Participants
|
|
Proportion of Subjects With Global Aesthetic Improvement Based on Modified Global Aesthetic Improvement Scale (GAIS) as Rated by Subject
Week 36
|
219 Participants
|
120 Participants
|
|
Proportion of Subjects With Global Aesthetic Improvement Based on Modified Global Aesthetic Improvement Scale (GAIS) as Rated by Subject
Week 48
|
213 Participants
|
99 Participants
|
|
Proportion of Subjects With Global Aesthetic Improvement Based on Modified Global Aesthetic Improvement Scale (GAIS) as Rated by Subject
Week 4
|
283 Participants
|
146 Participants
|
|
Proportion of Subjects With Global Aesthetic Improvement Based on Modified Global Aesthetic Improvement Scale (GAIS) as Rated by Subject
Week 8
|
281 Participants
|
142 Participants
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 16, 24, 36, and 48Population: 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.
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.
Outcome measures
| Measure |
Saypha® VOLUME Lidocaine
n=322 Participants
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.
|
Juvéderm® Voluma™ XC
n=161 Participants
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
|
|---|---|---|
|
Satisfaction With Outcome Based on FACE-Q(TM) Assessed by Subjects
Week 8
|
72.1 score on a scale
Standard Deviation 23.0
|
70.5 score on a scale
Standard Deviation 22.7
|
|
Satisfaction With Outcome Based on FACE-Q(TM) Assessed by Subjects
Week 16
|
68.6 score on a scale
Standard Deviation 23.1
|
68.7 score on a scale
Standard Deviation 21.6
|
|
Satisfaction With Outcome Based on FACE-Q(TM) Assessed by Subjects
Week 48
|
63.5 score on a scale
Standard Deviation 24.3
|
62.1 score on a scale
Standard Deviation 24.6
|
|
Satisfaction With Outcome Based on FACE-Q(TM) Assessed by Subjects
Week 24
|
68.2 score on a scale
Standard Deviation 23.4
|
68.4 score on a scale
Standard Deviation 22.6
|
|
Satisfaction With Outcome Based on FACE-Q(TM) Assessed by Subjects
Week 36
|
63.7 score on a scale
Standard Deviation 24.5
|
64.5 score on a scale
Standard Deviation 24.7
|
|
Satisfaction With Outcome Based on FACE-Q(TM) Assessed by Subjects
Week 4
|
73.2 score on a scale
Standard Deviation 20.6
|
72.6 score on a scale
Standard Deviation 21.1
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 16, 24, 36, and 48Population: 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.
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.
Outcome measures
| Measure |
Saypha® VOLUME Lidocaine
n=322 Participants
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.
|
Juvéderm® Voluma™ XC
n=161 Participants
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
|
|---|---|---|
|
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
|
44.5 score on a scale
Standard Deviation 30.0
|
|
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
|
40.4 score on a scale
Standard Deviation 31.3
|
|
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
|
39.1 score on a scale
Standard Deviation 30.1
|
|
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
|
36.8 score on a scale
Standard Deviation 31.4
|
|
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
|
32.8 score on a scale
Standard Deviation 30.3
|
|
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
|
28.7 score on a scale
Standard Deviation 30.2
|
SECONDARY outcome
Timeframe: 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 treatmentPopulation: 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.
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.
Outcome measures
| Measure |
Saypha® VOLUME Lidocaine
n=322 Participants
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.
|
Juvéderm® Voluma™ XC
n=161 Participants
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
|
|---|---|---|
|
Pain Assessment by Subjects
Pain assessment immediately after end of treatment - Baseline - Left
|
2.5 score on a scale
Standard Deviation 2.3
|
2.3 score on a scale
Standard Deviation 2.2
|
|
Pain Assessment by Subjects
Pain assessment 30 minutes after end of treatment - Baseline - Left
|
0.4 score on a scale
Standard Deviation 0.8
|
0.6 score on a scale
Standard Deviation 1.0
|
|
Pain Assessment by Subjects
Pain assessment 60 minutes after end of treatment - Baseline - Left
|
0.1 score on a scale
Standard Deviation 0.4
|
0.2 score on a scale
Standard Deviation 0.6
|
|
Pain Assessment by Subjects
Pain assessment 60 minutes after end of treatment - Baseline - Right
|
0.1 score on a scale
Standard Deviation 0.4
|
0.2 score on a scale
Standard Deviation 0.5
|
|
Pain Assessment by Subjects
Pain assessment immediately after end of treatment - Week 2 - Left
|
2.0 score on a scale
Standard Deviation 2.5
|
1.8 score on a scale
Standard Deviation 2.1
|
|
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
|
0.6 score on a scale
Standard Deviation 1.2
|
|
Pain Assessment by Subjects
Pain assessment 30 minutes after end of treatment - Week 2 - Left
|
0.4 score on a scale
Standard Deviation 1.0
|
0.3 score on a scale
Standard Deviation 0.8
|
|
Pain Assessment by Subjects
Pain assessment 30 minutes after end of treatment - Week 2 - Right
|
0.4 score on a scale
Standard Deviation 1.0
|
0.3 score on a scale
Standard Deviation 0.8
|
|
Pain Assessment by Subjects
Pain assessment 15 minutes after end of treatment - Baseline - Left
|
0.7 score on a scale
Standard Deviation 1.2
|
0.8 score on a scale
Standard Deviation 1.3
|
|
Pain Assessment by Subjects
Pain assessment 15 minutes after end of treatment - Baseline - Right
|
0.8 score on a scale
Standard Deviation 1.3
|
0.8 score on a scale
Standard Deviation 1.4
|
|
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
|
0.7 score on a scale
Standard Deviation 1.2
|
|
Pain Assessment by Subjects
Pain assessment 30 minutes after end of treatment - Baseline - Right
|
0.4 score on a scale
Standard Deviation 0.8
|
0.6 score on a scale
Standard Deviation 1.0
|
|
Pain Assessment by Subjects
Pain assessment 45 minutes after end of treatment - Baseline - Left
|
0.2 score on a scale
Standard Deviation 0.6
|
0.4 score on a scale
Standard Deviation 0.9
|
|
Pain Assessment by Subjects
Pain assessment immediately after end of treatment - Baseline - Right
|
2.5 score on a scale
Standard Deviation 2.2
|
2.3 score on a scale
Standard Deviation 2.3
|
|
Pain Assessment by Subjects
Pain assessment 45 minutes after end of treatment - Baseline - Right
|
0.2 score on a scale
Standard Deviation 0.6
|
0.4 score on a scale
Standard Deviation 0.9
|
|
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
|
0.2 score on a scale
Standard Deviation 0.6
|
|
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
|
0.2 score on a scale
Standard Deviation 0.6
|
|
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
|
0.1 score on a scale
Standard Deviation 0.5
|
|
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
|
0.1 score on a scale
Standard Deviation 0.5
|
|
Pain Assessment by Subjects
Pain assessment immediately after end of treatment - Week 2 - Right
|
1.9 score on a scale
Standard Deviation 2.4
|
1.9 score on a scale
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Baseline and Week 2Population: 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.
Injection volume required to achieve optimal aesthetic result at each treatment (baseline and touch-up treatment together) measured in mL.
Outcome measures
| Measure |
Saypha® VOLUME Lidocaine
n=322 Participants
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.
|
Juvéderm® Voluma™ XC
n=161 Participants
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
|
|---|---|---|
|
Evaluation of Injection Volume
|
5.163 mL
Standard Deviation 2.306
|
4.975 mL
Standard Deviation 2.251
|
Adverse Events
Saypha® VOLUME Lidocaine
Serious events: 4 serious events
Other events: 84 other events
Deaths: 1 deaths
Juvéderm® Voluma™ XC
Serious events: 2 serious events
Other events: 41 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Saypha® VOLUME Lidocaine
n=322 participants at risk
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.
|
Juvéderm® Voluma™ XC
n=161 participants at risk
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
|
|---|---|---|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/322 • 48 weeks
|
0.62%
1/161 • Number of events 1 • 48 weeks
|
|
Injury, poisoning and procedural complications
Overdose
|
0.31%
1/322 • Number of events 1 • 48 weeks
|
0.00%
0/161 • 48 weeks
|
|
Nervous system disorders
Cerebrovascular accident
|
0.31%
1/322 • Number of events 1 • 48 weeks
|
0.00%
0/161 • 48 weeks
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/322 • 48 weeks
|
0.62%
1/161 • Number of events 1 • 48 weeks
|
|
Psychiatric disorders
Mental disorder
|
0.31%
1/322 • Number of events 1 • 48 weeks
|
0.00%
0/161 • 48 weeks
|
|
Skin and subcutaneous tissue disorders
Vascular skin disorder
|
0.31%
1/322 • Number of events 1 • 48 weeks
|
0.00%
0/161 • 48 weeks
|
Other adverse events
| Measure |
Saypha® VOLUME Lidocaine
n=322 participants at risk
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.
|
Juvéderm® Voluma™ XC
n=161 participants at risk
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
|
|---|---|---|
|
Eye disorders
Vision blurred
|
2.5%
8/322 • Number of events 8 • 48 weeks
|
0.62%
1/161 • Number of events 1 • 48 weeks
|
|
General disorders
Injection site bruising
|
1.9%
6/322 • Number of events 6 • 48 weeks
|
3.1%
5/161 • Number of events 6 • 48 weeks
|
|
General disorders
Injection site pain
|
2.5%
8/322 • Number of events 10 • 48 weeks
|
0.62%
1/161 • Number of events 1 • 48 weeks
|
|
Infections and infestations
COVID-19
|
5.0%
16/322 • Number of events 16 • 48 weeks
|
3.1%
5/161 • Number of events 5 • 48 weeks
|
|
Infections and infestations
Nasopharyngitis
|
2.2%
7/322 • Number of events 7 • 48 weeks
|
3.7%
6/161 • Number of events 7 • 48 weeks
|
|
Infections and infestations
Sinusitis
|
2.5%
8/322 • Number of events 9 • 48 weeks
|
0.62%
1/161 • Number of events 1 • 48 weeks
|
|
Investigations
Palpatory finding abnormal
|
3.4%
11/322 • Number of events 12 • 48 weeks
|
6.2%
10/161 • Number of events 11 • 48 weeks
|
|
Investigations
Weight increased
|
0.62%
2/322 • Number of events 2 • 48 weeks
|
2.5%
4/161 • Number of events 4 • 48 weeks
|
|
Musculoskeletal and connective tissue disorders
Mastication disorder
|
1.2%
4/322 • Number of events 5 • 48 weeks
|
2.5%
4/161 • Number of events 4 • 48 weeks
|
|
Nervous system disorders
Dizziness
|
0.62%
2/322 • Number of events 2 • 48 weeks
|
3.7%
6/161 • Number of events 7 • 48 weeks
|
|
Nervous system disorders
Headache
|
14.0%
45/322 • Number of events 61 • 48 weeks
|
11.2%
18/161 • Number of events 21 • 48 weeks
|
|
Psychiatric disorders
Anxiety
|
0.62%
2/322 • Number of events 2 • 48 weeks
|
2.5%
4/161 • Number of events 4 • 48 weeks
|
Additional Information
Clinical Development - Head of Clinical Operations
Croma Pharma
Phone: +432262684680
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place