An interventional study of Emervel Deep Lidocaine and Juvederm Ultra Plus in Skin Wrinkling, sponsored by Galderma R&D. Completed at 11 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-23.
Sponsored by Galderma R&D · Not applicable, Interventional, and Treatment
The purpose of the study was to compare the effectiveness and safety of Emervel Deep Lidocaine versus Juvederm Ultra Plus in the treatment of moderate to severe facial wrinkles and folds.
This was a randomized, evaluator-blinded, active-controlled, multi-center, split-face comparison study of Emervel Deep Lidocaine versus Juvederm Ultra Plus in the treatment of moderate to severe facial wrinkles and folds. Two physicians, an Unblinded Injecting Investigator and a Blinded Evaluating Investigator, were required at each study center. The Unblinded Injecting Investigator was different from the Blinded Evaluating Investigator.
Galderma R&D is the lead sponsor of 280 studies on the registry; 9 are open to participants now.
Of its 59 completed or terminated interventional studies of FDA-regulated products, 55 (93%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
NLFs (Nasolabial Folds) were injected with Emervel Deep Lidocaine (20 mg/mL with 0.3% lidocaine).
Device: Emervel Deep Lidocaine
NLFs were injected with Juvéderm Ultra Plus (24 mg/mL).
Device: Juvederm Ultra Plus
20 mg/mL + 0.3% lidocaine
24mg/mL
Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at Week 24 After Final Initial Injection
WSRS is a validated 5-point reference scale with photographs that classifies deep 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.
Time frame: Baseline, Week 24 after final initial injection (Week 24 for participants without touch-up injection, Week 27 for participants with touch-up injection at Week 3)
Mean Change From Baseline in Wrinkle Severity Rating Score (WSRS) at Week 3 After Final Initial Injection
WSRS is a validated 5-point reference scale with photographs that classifies deep 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.
Time frame: Baseline, Week 3 after final initial injection (Week 3 for participants without touch-up injection, Week 6 for participants with touch-up injection at Week 3)
Mean Change From Baseline in Wrinkle Severity Rating Score (WSRS) at Week 12 After Final Initial Injection
WSRS is a validated 5-point reference scale with photographs that classifies deep 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.
Time frame: Baseline, Week 12 after final initial injection (Week 12 for participants without touch-up injection, Week 15 for participants with touch-up injection at Week 3)
Mean Change From Baseline in Wrinkle Severity Rating Score (WSRS) at Week 36 After Final Initial Injection
WSRS is a validated 5-point reference scale with photographs that classifies deep 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.
Time frame: Baseline, Week 36 after final initial injection (Week 36 for participants without touch-up injection, Week 39 for participants with touch-up injection at Week 3)
Mean Change From Baseline in Wrinkle Severity Rating Score (WSRS) at Week 48 After Final Initial Injection
WSRS is a 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.
Time frame: Baseline, Week 48 after final initial injection (Week 48 for participants without touch-up injection, Week 51 for participants with touch-up injection at Week 3)
Mean Change From Baseline in Participant Self-Assessment of Wrinkle Severity at Week 24 After Final Initial Injection
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.
Time frame: Baseline, Week 24 after final initial injection (Week 24 for participants without touch-up injection, Week 27 for participants with touch-up injection at Week 3)
Participant Pain Assessment After the Initial Injection
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 where a lower score correlates to better outcome for pain.
Time frame: At 0 ,15, 30, 45, 60 minutes and 24 hours after the initial injection (Baseline)
Participant Pain Assessment After the Initial Touch-up Injection
Participant pain severity for each NLF was assessed at time 0, 15, 30, 45, 60 minutes and 24 hours after the initial injection using 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 where a lower score correlates to better outcome for pain.
Time frame: At 0, 15, 30, 45, 60 minutes and 24 hours after the Initial Touch-up Injection (At 3 weeks after initial injection)
Number of Participants With Adverse Event (AEs)
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."
Time frame: From start of study drug administration up to 62 weeks
The study was conducted at 11 sites in the United States from 27 September 2010 to 12 January 2012.
| Milestone | All Participants |
|---|---|
| Started | 162 |
| Emervel deep lidocaine in left nlf followed by juvederm ultra in right nlf | 80 |
| Juvederm ultra in left nlf followed by emervel deep lidocaine in right nlf | 82 |
| Completed | 136 |
| Not completed | 26 |
| Withdrew: Adverse event | 4 |
| Withdrew: Withdrawal by subject | 11 |
| Withdrew: Clinical investigational plan violation | 1 |
| Withdrew: Lost to follow-up | 9 |
| Withdrew: Other | 1 |
WSRS is a validated 5-point reference scale with photographs that classifies deep 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.
| Score on a scale | Emervel Deep Lidocaine | Juvederm Ultra Plus |
|---|---|---|
| Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at Week 24 After Final Initial Injection | -1.1 ± 0.75 | -1.1 ± 0.68 |
WSRS is a validated 5-point reference scale with photographs that classifies deep 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.
| Score on a scale | Emervel Deep Lidocaine | Juvederm Ultra Plus |
|---|---|---|
| Mean Change From Baseline in Wrinkle Severity Rating Score (WSRS) at Week 3 After Final Initial Injection | -1.6 ± 0.62 | -1.6 ± 0.64 |
WSRS is a validated 5-point reference scale with photographs that classifies deep 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.
| Score on a scale | Emervel Deep Lidocaine | Juvederm Ultra Plus |
|---|---|---|
| Mean Change From Baseline in Wrinkle Severity Rating Score (WSRS) at Week 12 After Final Initial Injection | -1.3 ± 0.70 | -1.3 ± 0.74 |
WSRS is a validated 5-point reference scale with photographs that classifies deep 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.
| Score on a scale | Emervel Deep Lidocaine | Juvederm Ultra Plus |
|---|---|---|
| Mean Change From Baseline in Wrinkle Severity Rating Score (WSRS) at Week 36 After Final Initial Injection | -1.1 ± 0.67 | -1.1 ± 0.68 |
WSRS is a 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.
| Score on a scale | Emervel Deep Lidocaine | Juvederm Ultra Plus |
|---|---|---|
| Mean Change From Baseline in Wrinkle Severity Rating Score (WSRS) at Week 48 After Final Initial Injection | -0.8 ± 0.66 | -0.9 ± 0.66 |
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.
| Score on a scale | Emervel Deep Lidocaine | Juvederm Ultra Plus |
|---|---|---|
| Mean Change From Baseline in Participant Self-Assessment of Wrinkle Severity at Week 24 After Final Initial Injection | -1.2 ± 0.91 | -1.3 ± 0.75 |
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 where a lower score correlates to better outcome for pain.
| Score on a scale | Emervel Deep Lidocaine | Juvederm Ultra Plus |
|---|---|---|
| At 0 Minutes | 3.1 ± 2.1 | 5.3 ± 2.3 |
| At 15 Minutes | 0.5 ± 0.9 | 1.8 ± 1.8 |
| At 30 Minutes | 0.2 ± 0.6 | 1.0 ± 1.5 |
| At 45 Minutes | 0.1 ± 0.4 | 0.5 ± 1.0 |
| At 60 Minutes | 0.1 ± 0.3 | 0.3 ± 0.8 |
| At 24 Hours | 0.9 ± 1.5 | 0.9 ± 1.6 |
Participant pain severity for each NLF was assessed at time 0, 15, 30, 45, 60 minutes and 24 hours after the initial injection using 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 where a lower score correlates to better outcome for pain.
| Score on a scale | Emervel Deep Lidocaine | Juvederm Ultra Plus |
|---|---|---|
| At 0 Minutes | 3.3 ± 2.2 | 4.8 ± 2.4 |
| At 15 Minutes | 0.7 ± 1.2 | 1.2 ± 1.6 |
| At 30 Minutes | 0.3 ± 0.7 | 0.5 ± 1.0 |
| At 45 Minutes | 0.1 ± 0.4 | 0.2 ± 0.7 |
| At 60 Minutes | 0.1 ± 0.3 | 0.1 ± 0.5 |
| At 24 Hours | 0.5 ± 0.9 | 0.6 ± 1.3 |
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."
| Participants | Emervel Deep Lidocaine | Juvederm Ultra Plus |
|---|---|---|
| Number of Participants With Adverse Event (AEs) | 66 | 67 |
Collected over From start of study drug administration up to 62 weeks. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Emervel Deep Lidocaine | 0/162 (0%) | 7/162 (4.3%) | 16/162 (9.9%) |
| Juvederm Ultra Plus | 0/162 (0%) | 7/162 (4.3%) | 16/162 (9.9%) |
| Event | Emervel Deep Lidocaine | Juvederm Ultra Plus |
|---|---|---|
| Colon cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/162 | 1/162 |
| Lung cancer metastaticNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/162 | 1/162 |
| Uterine LeiomyomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/162 | 1/162 |
| Herpes ZosterInfections and infestations | 1/162 | 1/162 |
| Diarrhoea infectionsInfections and infestations | 1/162 | 1/162 |
| Small intestinal obstructionGastrointestinal disorders | 1/162 | 1/162 |
| Lumbar Spinal stenosisInfections and infestations | 1/162 | 1/162 |
| Ovarian CystReproductive system and breast disorders | 1/162 | 1/162 |
| Event | Emervel Deep Lidocaine | Juvederm Ultra Plus |
|---|---|---|
| Upper respiratory tract infectionInfections and infestations | 6/162 | 6/162 |
| SinusitisInfections and infestations | 5/162 | 5/162 |
| MigraineNervous system disorders | 5/162 | 5/162 |
The intent-to-treat population included all participants who were randomized and received an injection on both treatment sides.
| Age, Continuous(years) | Emervel Deep Lidocaine in Left NLF Followed by Juvederm Ultra Plus in Right NLF | Juvederm Ultra Plus in Left NLF Followed by Emervel Deep Lidocaine in Right NLF | Total |
|---|---|---|---|
| Mean | 53.4 ± 9.29 | 54.0 ± 8.09 | 53.7 ± 8.68 |
| Sex: Female, Male(Participants) | Emervel Deep Lidocaine in Left NLF Followed by Juvederm Ultra Plus in Right NLF | Juvederm Ultra Plus in Left NLF Followed by Emervel Deep Lidocaine in Right NLF | Total |
|---|---|---|---|
| Female | 78 | 78 | 156 |
| Male | 2 | 4 | 6 |
| Race/Ethnicity, Customized(Participants) | Emervel Deep Lidocaine in Left NLF Followed by Juvederm Ultra Plus in Right NLF | Juvederm Ultra Plus in Left NLF Followed by Emervel Deep Lidocaine in Right NLF | Total |
|---|---|---|---|
| Race — Caucasian | 63 | 66 | 129 |
| Race — Black | 9 | 11 | 20 |
| Race — Hispanic | 5 | 5 | 10 |
| Race — Other | 3 | 0 | 3 |
| Skin Type(Participants) | Emervel Deep Lidocaine in Left NLF Followed by Juvederm Ultra Plus in Right NLF | Juvederm Ultra Plus in Left NLF Followed by Emervel Deep Lidocaine in Right NLF | Total |
|---|---|---|---|
| Type I | 1 | 5 | 6 |
| Type II | 16 | 12 | 28 |
| Type III | 30 | 37 | 67 |
| Type IV | 18 | 16 | 34 |
| Type V | 11 | 8 | 19 |
| Type VI | 4 | 4 | 8 |
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Galderma R&D