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The purpose of this study is to compare the effectiveness and safety of Emervel Classic Lidocaine versus Juvederm® Ultra in the treatment of moderate to severe facial wrinkles and folds.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Emervel Classic Lidocaine | Experimental | NLFs (Nasolabial Folds) were injected with Emervel Classic Lidocaine (20 mg/mL with 0.3% lidocaine). |
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| Juvederm® Ultra | Active Comparator | NLFs were injected with Juvéderm Ultra (24 mg/mL). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emervel Classic Lidocaine | Device | 20 mg/mL + 0.3% lidocaine |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 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. | Baseline, Week 24 after final initial injection |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at Week 3 After the Final Initial Injection | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Operations | Galderma R&D | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Total Skin and Beauty Dermatology Center, PC | Birmingham | Alabama | 35202 | United States | ||
| Skin Care & Laser Physicians of Beverly Hills |
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A total of 171 participants were enrolled, of which 170 participants received treatment in this study.
The study was conducted at 12 centers in the United States from September 2010 to January 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Juvederm® Ultra |
| Device |
24mg/mL |
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| Baseline, Week 3 after final initial injection |
| Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at Week 12 After Final Initial Injection | 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. | Baseline, Week 12 after final initial injection |
| Mean Change From Baseline in Wrinkle Severity Scale (WSRS) at Week 36 After Final Initial Injection | 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. | Baseline, Week 36 after final initial injection |
| Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at Week 48 After Final Initial Injection | 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. | Baseline, Week 48 after final initial injection |
| 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. | Baseline, Week 24 after final initial injection |
| 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. | At 0 ,15, 30, 45, 60 minutes and 24 hours after the initial injection |
| 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 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. | At 0, 15, 30, 45, 60 minutes and 24 hours after the Initial Touch-up Injection |
| Number of Participants With Adverse Events (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." | From start of study drug administration up to 56 weeks |
| Los Angeles |
| California |
| 90069 |
| United States |
| FacesPlus Aesthetic Facility | San Diego | California | 92122 | United States |
| Therapeutics Research | San Diego | California | 92123 | United States |
| Steven Fagien | Boca Raton | Florida | 33431 | United States |
| Dermatology Research Institute | Coral Gables | Florida | 33146 | United States |
| Laser & Skin Surgery Center in Indiana | Carmel | Indiana | 46032 | United States |
| Callender Center for Clinical Research | Glendale | Maryland | 20769 | United States |
| The Center for Dermatology, Cosmetic & Laser Surgery | Mount Kisco | New York | 10549 | United States |
| Sadick Research Group | New York | New York | 10075 | United States |
| Oregon Medical Research PC | Portland | Oregon | 97223 | United States |
| DermResearch | Austin | Texas | 78759 | United States |
| Emervel Classic Lidocaine in Left NLF Followed by Juvederm Ultra in Right NLF |
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| Juvederm Ultra in Left NLF Followed by Emervel Classic Lidocaine in Right NLF |
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| COMPLETED |
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| NOT COMPLETED |
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The Intent to treat (ITT) population was defined as all participants who were randomized and received an injection on both treatment sides.
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| ID | Title | Description |
|---|---|---|
| BG000 | Emervel Classic Lidocaine in Left NLF Followed by Juvederm Ultra in Right NLF | 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. |
| BG001 | Juvederm Ultra in Left NLF Followed by Emervel Classic Lidocaine in Right NLF | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Fitzpatrick Skin Type | Skin Type I = White; very fair, red or blonde hair blue eyes; freckles; Always burns, never tans Skin Type II = White, fair, red or blond hair; blue, hazel or green eyes; Usually burns, tans with difficulty Skin Type III = Cream white; fair with any eye or hair color (common); Sometimes mild burn, gradually tans Skin Type IV = Brown; typical Mediterranean Caucasian skin; Rarely burns, tans with ease Skin Type V = Dark Brown; mid-eastern skin types; Very rarely burns, tans easily Skin Type VI = Black; Never burns, tans very easily | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 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. | Intent to Treat (ITT) population included participants who were randomized and received an injection on both treatment sides. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Week 24 after final initial injection |
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| Secondary | Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at Week 3 After the Final Initial Injection | 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. | ITT population included participants who were randomized and received an injection on both treatment sides. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Week 3 after final initial injection |
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| Secondary | Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at Week 12 After Final Initial Injection | 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. | ITT population included participants who were randomized and received an injection on both treatment sides. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Week 12 after final initial injection |
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| Secondary | Mean Change From Baseline in Wrinkle Severity Scale (WSRS) at Week 36 After Final Initial Injection | 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. | ITT population included participants who were randomized and received an injection on both treatment sides. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Week 36 after final initial injection |
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| Secondary | Mean Change From Baseline in Wrinkle Severity Rating Scale (WSRS) at Week 48 After Final Initial Injection | 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. | ITT population included participants who were randomized and received an injection on both treatment sides. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Week 48 after final initial injection |
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| Secondary | 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. | ITT population included participants who were randomized and received an injection on both treatment sides. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, Week 24 after final initial injection |
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| Secondary | 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. | 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". | Posted | Mean | Full Range | Score on a scale | At 0 ,15, 30, 45, 60 minutes and 24 hours after the initial injection |
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| Secondary | 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 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. | 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. | Posted | Mean | Full Range | Score on a scale | At 0, 15, 30, 45, 60 minutes and 24 hours after the Initial Touch-up Injection |
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| Secondary | Number of Participants With Adverse Events (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." | The safety population included all participants who received at least one injection. | Posted | Count of Participants | Participants | From start of study drug administration up to 56 weeks |
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From start of study drug administration up to 56 weeks
The safety population included all participants who received at least one injection.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Emervel Classic Lidocaine | NLFs were injected with Emervel Classic Lidocaine (20 mg/mL with 0.3% lidocaine). | 0 | 170 | 2 | 170 | 10 | 170 |
| EG001 | Juvederm Ultra | NLFs were injected with Juvéderm Ultra (24 mg/mL). | 0 | 170 | 2 | 170 | 11 | 170 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholecystitis | General disorders | 13.0 | Non-systematic Assessment | 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." |
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| Worsening right knee osteoarthritis | General disorders | MedDRA 13.0 | Non-systematic Assessment | 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." |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 13.0 | Non-systematic Assessment | 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." |
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| Title | Organization | Phone | Extension | |
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| Clinical Scientist | Galderma | +46184749000 | reception.seupp@galderma.com |
| Male |
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| Black |
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| Hispanic |
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| Other |
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| Skin Type II |
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| Skin Type III |
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| Skin Type IV |
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| Skin Type V |
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| Skin Type VI |
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