Trial Outcomes & Findings for Emervel Classic Lidocaine Versus Juvederm® Ultra in Treatment of Moderate to Severe Facial Wrinkles and Folds (NCT NCT01205048)
NCT ID: NCT01205048
Last Updated: 2023-07-25
Results Overview
WSRS is a validated 5-point reference scale with photographs that classifies facial wrinkles (nasolabial folds). WSRS represents clinically meaningful change in NLF severity from the adjacent grades where 1= absent (no visible fold; continuous skin line), 2 = mild (shallow but visible fold with a slight indentation; minor facial feature; implant expected to produce a slight improvement in appearance), 3 = excellent (correction is expected from injectable implant), 4 = severe (very long and deep folds; prominent facial feature; less than 2 mm visible fold when stretched; significant improvement expected from injectable implant), 5 = extreme (extremely deep and long folds, detrimental to facial appearance; 2 to 4 millimeter (mm) visible V-shaped fold when stretched; unlikely to have satisfactory correction with injectable implant alone). A negative change from baseline indicates improvement.
COMPLETED
NA
171 participants
Baseline, Week 24 after final initial injection
2023-07-25
Participant Flow
The study was conducted at 12 centers in the United States from September 2010 to January 2012.
A total of 171 participants were enrolled, of which 170 participants received treatment in this study.
Participant milestones
| Measure |
All Participants
Participants were randomized to receive either Emervel Classic Lidocaine (20 milligram per milliliter \[mg/mL\] with 0.3% lidocaine) injection in the left nasolabial fold (NLF) and Juvederm Ultra (24 mg/mL) injection in to the right NLF or Juvederm Ultra (24 mg/mL) injection in the left NLF and Emervel Classic Lidocaine (20 mg/mL with 0.3% lidocaine) injection in the right NLF.
|
|---|---|
|
Overall Study
STARTED
|
170
|
|
Overall Study
Emervel Classic Lidocaine in Left NLF Followed by Juvederm Ultra in Right NLF
|
84
|
|
Overall Study
Juvederm Ultra in Left NLF Followed by Emervel Classic Lidocaine in Right NLF
|
86
|
|
Overall Study
COMPLETED
|
149
|
|
Overall Study
NOT COMPLETED
|
21
|
Reasons for withdrawal
| Measure |
All Participants
Participants were randomized to receive either Emervel Classic Lidocaine (20 milligram per milliliter \[mg/mL\] with 0.3% lidocaine) injection in the left nasolabial fold (NLF) and Juvederm Ultra (24 mg/mL) injection in to the right NLF or Juvederm Ultra (24 mg/mL) injection in the left NLF and Emervel Classic Lidocaine (20 mg/mL with 0.3% lidocaine) injection in the right NLF.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
14
|
|
Overall Study
Clinical Investigation Plan Violation
|
1
|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Other
|
2
|
Baseline Characteristics
Emervel Classic Lidocaine Versus Juvederm® Ultra in Treatment of Moderate to Severe Facial Wrinkles and Folds
Baseline characteristics by cohort
| Measure |
Emervel Classic Lidocaine in Left NLF Followed by Juvederm Ultra in Right NLF
n=84 Participants
Participants received Emervel Classic Lidocaine (20 mg/mL with 0.3% lidocaine) injection into the left NLF and Juvéderm Ultra (24 mg/mL) in the right NLF.
|
Juvederm Ultra in Left NLF Followed by Emervel Classic Lidocaine in Right NLF
n=86 Participants
Participants received Juvéderm Ultra (24 mg/mL) injection into the left NLF and Emervel Classic Lidocaine (20 mg/mL with 0.3% lidocaine) injection in the right NLF.
|
Total
n=170 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.1 years
STANDARD_DEVIATION 8.82 • n=5 Participants
|
53.6 years
STANDARD_DEVIATION 7.64 • n=7 Participants
|
53.9 years
STANDARD_DEVIATION 8.22 • n=5 Participants
|
|
Sex: Female, Male
Female
|
79 Participants
n=5 Participants
|
81 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
58 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
5 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Skin Type I
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Skin Type II
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Skin Type III
|
29 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
52 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Skin Type IV
|
27 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Skin Type V
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Skin Type VI
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 24 after final initial injectionPopulation: Intent to Treat (ITT) population included participants who were randomized and received an injection on both treatment sides.
WSRS is a validated 5-point reference scale with photographs that classifies facial wrinkles (nasolabial folds). WSRS represents clinically meaningful change in NLF severity from the adjacent grades where 1= absent (no visible fold; continuous skin line), 2 = mild (shallow but visible fold with a slight indentation; minor facial feature; implant expected to produce a slight improvement in appearance), 3 = excellent (correction is expected from injectable implant), 4 = severe (very long and deep folds; prominent facial feature; less than 2 mm visible fold when stretched; significant improvement expected from injectable implant), 5 = extreme (extremely deep and long folds, detrimental to facial appearance; 2 to 4 millimeter (mm) visible V-shaped fold when stretched; unlikely to have satisfactory correction with injectable implant alone). A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Emervel Classic Lidocaine
n=170 Participants
NLFs were injected with Emervel Classic Lidocaine (20 mg/mL with 0.3% lidocaine).
|
Juvederm Ultra
n=170 Participants
NLFs were injected with Juvéderm Ultra (24 mg/mL).
|
|---|---|---|
|
Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at Week 24 After Final Initial Injection
|
-1.1 Score on a scale
Standard Deviation 0.75
|
-1.2 Score on a scale
Standard Deviation 0.76
|
SECONDARY outcome
Timeframe: Baseline, Week 3 after final initial injectionPopulation: ITT population included participants who were randomized and received an injection on both treatment sides.
WSRS is a validated 5-point reference scale with photographs that classifies facial wrinkles (nasolabial folds). WSRS represents a clinically meaningful change in NLF severity from the adjacent grades where 1 = absent (no visible fold; continuous skin line), 2 = mild (shallow but visible fold with a slight indentation; minor facial feature; implant is expected to produce a slight improvement in appearance), 3 = excellent (correction is expected from injectable implant), 4 = severe (very long and deep folds; prominent facial feature; less than 2 mm visible fold when stretched; significant improvement is expected from injectable implant), 5 = extreme (extremely deep and long folds, detrimental to facial appearance; 2 to 4 mm visible V-shaped fold when stretched; unlikely to have satisfactory correction with injectable implant alone). A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Emervel Classic Lidocaine
n=170 Participants
NLFs were injected with Emervel Classic Lidocaine (20 mg/mL with 0.3% lidocaine).
|
Juvederm Ultra
n=170 Participants
NLFs were injected with Juvéderm Ultra (24 mg/mL).
|
|---|---|---|
|
Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at Week 3 After the Final Initial Injection
|
-1.7 Score on a scale
Standard Deviation 0.72
|
-1.8 Score on a scale
Standard Deviation 0.70
|
SECONDARY outcome
Timeframe: Baseline, Week 12 after final initial injectionPopulation: ITT population included participants who were randomized and received an injection on both treatment sides.
WSRS is a validated 5-point reference scale with photographs that classifies facial wrinkles (nasolabial folds). WSRS represents a clinically meaningful change in nasolabial fold severity from the adjacent grades where 1 = absent (no visible fold; continuous skin line), 2 = mild (shallow but visible fold with a slight indentation; minor facial feature; implant is expected to produce a slight improvement in appearance), 3 = excellent (correction is expected from injectable implant), 4 = severe (very long and deep folds; prominent facial feature; less than 2 mm visible fold when stretched; significant improvement is expected from injectable implant), 5 = extreme (extremely deep and long folds, detrimental to facial appearance; 2 to 4 mm visible V-shaped fold when stretched; unlikely to have satisfactory correction with injectable implant alone). A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Emervel Classic Lidocaine
n=170 Participants
NLFs were injected with Emervel Classic Lidocaine (20 mg/mL with 0.3% lidocaine).
|
Juvederm Ultra
n=170 Participants
NLFs were injected with Juvéderm Ultra (24 mg/mL).
|
|---|---|---|
|
Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at Week 12 After Final Initial Injection
|
-1.5 score on a scale
Standard Deviation 0.75
|
-1.5 score on a scale
Standard Deviation 0.78
|
SECONDARY outcome
Timeframe: Baseline, Week 36 after final initial injectionPopulation: ITT population included participants who were randomized and received an injection on both treatment sides.
WSRS is a validated 5-point reference scale with photographs that classifies facial wrinkles (nasolabial folds). WSRS represents a clinically meaningful change in NLF severity from the adjacent grades where 1 = absent (no visible fold; continuous skin line), 2 = mild (shallow but visible fold with a slight indentation; minor facial feature; implant is expected to produce a slight improvement in appearance), 3 = excellent (correction is expected from injectable implant), 4 = severe (very long and deep folds; prominent facial feature; less than 2 mm visible fold when stretched; significant improvement is expected from injectable implant), 5 = extreme (extremely deep and long folds, detrimental to facial appearance; 2 to 4 mm visible V-shaped fold when stretched; unlikely to have satisfactory correction with injectable implant alone). A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Emervel Classic Lidocaine
n=170 Participants
NLFs were injected with Emervel Classic Lidocaine (20 mg/mL with 0.3% lidocaine).
|
Juvederm Ultra
n=170 Participants
NLFs were injected with Juvéderm Ultra (24 mg/mL).
|
|---|---|---|
|
Mean Change From Baseline in Wrinkle Severity Scale (WSRS) at Week 36 After Final Initial Injection
|
-1.0 Score on a scale
Standard Deviation 0.75
|
-1.1 Score on a scale
Standard Deviation 0.74
|
SECONDARY outcome
Timeframe: Baseline, Week 48 after final initial injectionPopulation: ITT population included participants who were randomized and received an injection on both treatment sides.
WSRS is a validated 5-point reference scale with photographs that classifies facial wrinkles (nasolabial folds). WSRS represents a clinically meaningful change in NLF severity from the adjacent grades where 1 = absent (no visible fold; continuous skin line), 2 = mild (shallow but visible fold with a slight indentation; minor facial feature; implant is expected to produce a slight improvement in appearance), 3 = excellent (correction is expected from injectable implant), 4 = severe (very long and deep folds; prominent facial feature; less than 2 mm visible fold when stretched; significant improvement is expected from injectable implant), 5 = extreme (extremely deep and long folds, detrimental to facial appearance; 2 to 4 mm visible V-shaped fold when stretched; unlikely to have satisfactory correction with injectable implant alone). A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Emervel Classic Lidocaine
n=170 Participants
NLFs were injected with Emervel Classic Lidocaine (20 mg/mL with 0.3% lidocaine).
|
Juvederm Ultra
n=170 Participants
NLFs were injected with Juvéderm Ultra (24 mg/mL).
|
|---|---|---|
|
Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at Week 48 After Final Initial Injection
|
-0.7 Score on a scale
Standard Deviation 0.69
|
-0.9 Score on a scale
Standard Deviation 0.76
|
SECONDARY outcome
Timeframe: Baseline, Week 24 after final initial injectionPopulation: ITT population included participants who were randomized and received an injection on both treatment sides.
Participants self-assessment was measured by using a wrinkle severity scale with 1 being absent and 5 being extreme. Each participant was to perform an assessment of the wrinkle severity based on self-assessment score: 1= Absent (No visible fold; continuous skin line), 2= Mild (Shallow but visible fold with a slight indentation), 3= Moderate (Moderately deep folds), 4= Severe (Very long and deep fold), 5= Extreme (Extremely deep and long folds). A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Emervel Classic Lidocaine
n=170 Participants
NLFs were injected with Emervel Classic Lidocaine (20 mg/mL with 0.3% lidocaine).
|
Juvederm Ultra
n=170 Participants
NLFs were injected with Juvéderm Ultra (24 mg/mL).
|
|---|---|---|
|
Mean Change From Baseline in Participant Self-Assessment of Wrinkle Severity at Week 24 After Final Initial Injection
|
-1.3 Score on a scale
Standard Deviation 1.04
|
-1.4 Score on a scale
Standard Deviation 0.96
|
SECONDARY outcome
Timeframe: At 0 ,15, 30, 45, 60 minutes and 24 hours after the initial injectionPopulation: ITT population included participants who were randomized and received an injection on both treatment sides. "Here, "number analyzed signifies who were evaluable at the given timepoints".
Participant pain severity for each NLF was assessed at time 0, 15, 30, 45, 60 minutes and 24 hours after the initial injection using an 11-point Numeric Pain Intensity Scale (NPIS).The NPIS was a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with 0 is no pain and 10 is the worst possible pain.
Outcome measures
| Measure |
Emervel Classic Lidocaine
n=170 Participants
NLFs were injected with Emervel Classic Lidocaine (20 mg/mL with 0.3% lidocaine).
|
Juvederm Ultra
n=170 Participants
NLFs were injected with Juvéderm Ultra (24 mg/mL).
|
|---|---|---|
|
Participant Pain Assessment After the Initial Injection
At 0 Minutes
|
2.9 Score on a scale
Interval 0.0 to 8.0
|
5.6 Score on a scale
Interval 0.0 to 10.0
|
|
Participant Pain Assessment After the Initial Injection
At 15 Minutes
|
0.5 Score on a scale
Interval 0.0 to 6.0
|
2.1 Score on a scale
Interval 0.0 to 8.0
|
|
Participant Pain Assessment After the Initial Injection
At 30 Minutes
|
0.2 Score on a scale
Interval 0.0 to 4.0
|
1.1 Score on a scale
Interval 0.0 to 8.0
|
|
Participant Pain Assessment After the Initial Injection
At 45 Minutes
|
0.2 Score on a scale
Interval 0.0 to 3.0
|
0.7 Score on a scale
Interval 0.0 to 7.0
|
|
Participant Pain Assessment After the Initial Injection
At 60 Minutes
|
0.1 Score on a scale
Interval 0.0 to 2.0
|
0.5 Score on a scale
Interval 0.0 to 5.0
|
|
Participant Pain Assessment After the Initial Injection
At 24 Hours
|
0.4 Score on a scale
Interval 0.0 to 5.0
|
0.4 Score on a scale
Interval 0.0 to 4.0
|
SECONDARY outcome
Timeframe: At 0, 15, 30, 45, 60 minutes and 24 hours after the Initial Touch-up InjectionPopulation: ITT population included participants who were randomized and received an injection on both treatment sides. "Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure and number analyzed signifies who were evaluable at the given timepoints.
Participant pain severity for each NLF was assessed at time 0, 15, 30, 45, 60 minutes and 24 hours after the initial injection using an 11-point Numeric Pain Intensity Scale (NPIS).The NPIS was a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with 0 is no pain and 10 is the worst possible pain.
Outcome measures
| Measure |
Emervel Classic Lidocaine
n=90 Participants
NLFs were injected with Emervel Classic Lidocaine (20 mg/mL with 0.3% lidocaine).
|
Juvederm Ultra
n=86 Participants
NLFs were injected with Juvéderm Ultra (24 mg/mL).
|
|---|---|---|
|
Participant Pain Assessment After the Initial Touch-up Injection
At 0 Minutes
|
2.3 Score on a scale
Interval 0.0 to 8.0
|
4.4 Score on a scale
Interval 0.0 to 10.0
|
|
Participant Pain Assessment After the Initial Touch-up Injection
At 15 Minutes
|
0.3 Score on a scale
Interval 0.0 to 4.0
|
1.4 Score on a scale
Interval 0.0 to 6.0
|
|
Participant Pain Assessment After the Initial Touch-up Injection
At 30 Minutes
|
0.2 Score on a scale
Interval 0.0 to 3.0
|
0.6 Score on a scale
Interval 0.0 to 5.0
|
|
Participant Pain Assessment After the Initial Touch-up Injection
At 45 Minutes
|
0.1 Score on a scale
Interval 0.0 to 2.0
|
0.3 Score on a scale
Interval 0.0 to 4.0
|
|
Participant Pain Assessment After the Initial Touch-up Injection
At 60 Minutes
|
0.1 Score on a scale
Interval 0.0 to 2.0
|
0.2 Score on a scale
Interval 0.0 to 3.0
|
|
Participant Pain Assessment After the Initial Touch-up Injection
At 24 Hours
|
0.2 Score on a scale
Interval 0.0 to 2.0
|
0.3 Score on a scale
Interval 0.0 to 4.0
|
SECONDARY outcome
Timeframe: From start of study drug administration up to 56 weeksPopulation: The safety population included all participants who received at least one injection.
AE was defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with the study drug. Number of participants with AEs were reported. Event was unrelated to study product or injection procedure. If the treated side where an AE occurred was not applicable, this AE was summarized under each treatment group."
Outcome measures
| Measure |
Emervel Classic Lidocaine
n=170 Participants
NLFs were injected with Emervel Classic Lidocaine (20 mg/mL with 0.3% lidocaine).
|
Juvederm Ultra
n=170 Participants
NLFs were injected with Juvéderm Ultra (24 mg/mL).
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs)
|
66 Participants
|
64 Participants
|
Adverse Events
Emervel Classic Lidocaine
Juvederm Ultra
Serious adverse events
| Measure |
Emervel Classic Lidocaine
n=170 participants at risk
NLFs were injected with Emervel Classic Lidocaine (20 mg/mL with 0.3% lidocaine).
|
Juvederm Ultra
n=170 participants at risk
NLFs were injected with Juvéderm Ultra (24 mg/mL).
|
|---|---|---|
|
General disorders
Cholecystitis
|
0.59%
1/170 • From start of study drug administration up to 56 weeks
The safety population included all participants who received at least one injection.
|
0.59%
1/170 • From start of study drug administration up to 56 weeks
The safety population included all participants who received at least one injection.
|
|
General disorders
Worsening right knee osteoarthritis
|
0.59%
1/170 • From start of study drug administration up to 56 weeks
The safety population included all participants who received at least one injection.
|
0.59%
1/170 • From start of study drug administration up to 56 weeks
The safety population included all participants who received at least one injection.
|
Other adverse events
| Measure |
Emervel Classic Lidocaine
n=170 participants at risk
NLFs were injected with Emervel Classic Lidocaine (20 mg/mL with 0.3% lidocaine).
|
Juvederm Ultra
n=170 participants at risk
NLFs were injected with Juvéderm Ultra (24 mg/mL).
|
|---|---|---|
|
Nervous system disorders
Headache
|
5.9%
10/170 • From start of study drug administration up to 56 weeks
The safety population included all participants who received at least one injection.
|
6.5%
11/170 • From start of study drug administration up to 56 weeks
The safety population included all participants who received at least one injection.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER