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This study is designed to
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Emervel Treatment Group | Experimental | Eligible subjects received bilateral treatment of Nasolabial Folds (NLFs) and Marionette Lines (MLs) with Emervel Classic and/or Emervel Deep |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emervel Classic and/or Deep Treatment Group | Device | Severity of Wrinkle Severity treated by product type: Emervel Classic: Nasolabial Folds (NLFs): Wrinkle Severity Rating Scale (WSRS) = 2/2, 2/3 or 3/3; Marionette Lines (MLs): Wrinkle Assessment Scale (WAS) = 2/2, 2/3 or 3/3 Emervel Deep Nasolabial Folds (NLFs): Wrinkle Severity Rating Scale (WSRS) = 3/3, 3/4 or 4/4; Marionette Lines (MLs): Wrinkle Assessment Scale (WAS) = 3/3, 3/4 or 4/4 Both products may be used in the same subject, but only in different anatomic locations. The same study product should be used within the same wrinkle or fold type (e.g., left and right NLFs treated with the same product) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Naturalness of Expression in Motion (2D Video) | Proportion of subjects having at least maintained naturalness of expression in lower face (naturalness is maintained or enhanced) based on 2D video assessment at Day 42, by treating investigator | 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Naturalness of Expression (Photographs) | Proportion of subjects having at least maintained naturalness of facial expression based on photograph assessment at Day 42, by treating investigator | 42 days |
| Number of Subjects With Naturalness of Expression, Attractiveness AND Younger Appearance (2D Video) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jay Mashburn | Galderma Laboratories | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | Emervel Treatment Group | Eligible subjects received bilateral treatment of Nasolabial Folds (NLFs) and Marionette Lines (MLs) with Emervel Classic and/or Emervel Deep Emervel Classic and/or Deep Treatment Group: Severity of Wrinkle Severity treated by product type: Emervel Classic: Nasolabial Folds (NLFs): Wrinkle Severity Rating Scale (WSRS) = 2/2, 2/3 or 3/3; Marionette Lines (MLs): Wrinkle Assessment Scale (WAS) = 2/2, 2/3 or 3/3 Emervel Deep Nasolabial Folds (NLFs): Wrinkle Severity Rating Scale (WSRS) = 3/3, 3/4 or 4/4; Marionette Lines (MLs): Wrinkle Assessment Scale (WAS) = 3/3, 3/4 or 4/4 Both products may be used in the same subject, but only in different anatomic locations. The same study product should be used within the same wrinkle or fold type (e.g., left and right NLFs treated with the same product) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Emervel Treatment Group | Eligible subjects received bilateral treatment of Nasolabial Folds (NLFs) and Marionette Lines (MLs) with Emervel Classic and/or Emervel Deep Emervel Classic and/or Deep Treatment Group: Severity of Wrinkle Severity treated by product type: Emervel Classic: Nasolabial Folds (NLFs): Wrinkle Severity Rating Scale (WSRS) = 2/2, 2/3 or 3/3; Marionette Lines (MLs): Wrinkle Assessment Scale (WAS) = 2/2, 2/3 or 3/3 Emervel Deep Nasolabial Folds (NLFs): Wrinkle Severity Rating Scale (WSRS) = 3/3, 3/4 or 4/4; Marionette Lines (MLs): Wrinkle Assessment Scale (WAS) = 3/3, 3/4 or 4/4 Both products may be used in the same subject, but only in different anatomic locations. The same study product should be used within the same wrinkle or fold type (e.g., left and right NLFs treated with the same product) |
| 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 |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Subjects With Naturalness of Expression in Motion (2D Video) | Proportion of subjects having at least maintained naturalness of expression in lower face (naturalness is maintained or enhanced) based on 2D video assessment at Day 42, by treating investigator | Posted | Count of Participants | Participants | 42 days |
|
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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 Treatment Group | Eligible subjects receive bilateral treatment of Nasolabial Folds (NLFs) and Marionette Lines (MLs) with Emervel Classic and/or Emervel Deep Emervel Classic and/or Deep Treatment Group: Severity of Wrinkle Severity to be treated by product type: Emervel Classic: Nasolabial Folds (NLFs): Wrinkle Severity Rating Scale (WSRS) = 2/2, 2/3 or 3/3; Marionette Lines (MLs): Wrinkle Assessment Scale (WAS) = 2/2, 2/3 or 3/3 Emervel Deep Nasolabial Folds (NLFs): Wrinkle Severity Rating Scale (WSRS) = 3/3, 3/4 or 4/4; Marionette Lines (MLs): Wrinkle Assessment Scale (WAS) = 3/3, 3/4 or 4/4 Both products may be used in the same subject, but only in different anatomic locations. The same study product should be used within the same wrinkle or fold type (e.g., left and right NLFs treated with the same product) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jay Mashburn | Galderma Laboratories | jay.mashburn@galderma.com |
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Proportion of subjects having at least maintained naturalness of expression in the lower face (naturalness is maintained or enhanced) AND attractiveness of the lower face is enhanced AND age of the lower face is younger, based on 2D video assessment at Day 42, by the treating investigator. The is a composite perception assessment; the proportion of subjects must meet all 3 criteria (maintain naturalness, maintain attractiveness, and appear younger in the lower face. |
| 42 days |
| Number of Subjects Reporting Global Improvement (Subject) | Aesthetic improvement assessed by subject using the Global Aesthetic Improvement Scale (GAIS). The subject reported GAIS assessment was based on comparing Day 42 to baseline photographs with the following ratings: Very much improved, much improved, somewhat improved, no change, and worse. A clinically significant "global" improvement was defined as a score of improved, much improved, or very much improved. | 42 days |
| Number of Subjects Demonstrating Global Improvement (Treating Investigator) | Aesthetic improvement assessed by treating investigator using the Global Aesthetic Improvement Scale (GAIS). The treating investigator reported GAIS assessment was based on comparing Day 42 to baseline photographs with the following ratings: Very much improved, much improved, somewhat improved, no change, and worse. A clinically significant "global" improvement was defined as a score of improved, much improved, or very much improved. | 42 days |
| Number of Subjects Reporting Satisfaction - The Overall Appearance of my Face Looks Natural | Proportion of subjects responding with Strongly Agree or Agree. Subject reported satisfaction using a 5-point Likert scale questionnaire. Responses were 1-strongly disagree, 2-disagree, 3-neutral, 4-agree, and 5-strongly agree. | 42 days |
| Wrinkle Severity (Assess NLFs) - Proportion of Subjects With Bilateral Improvement of at Least 1 Grade in Wrinkle Severity | Wrinkle severity assessed by treating investigator at Day 15/Touch and Day 42 using the Wrinkle Severity Rating Scale (WSRS). Assessments of both NLFs were graded according the following responses: 1-absent, 2-mild, 3-moderate, 4-severe, and 5-extreme. WSRS improvement from baseline included 1-grade improvement (reduction in WSRS) from baseline. | 42 days |
| Wrinkle Severity (Assess MLs) - Proportion of Subjects With Bilateral Improvement of at Least 1 Grade in Wrinkle Severity | Wrinkle severity assessed by treating investigator at Day 15/Touch and Day 42 using the Wrinkle Assessment Scale (WAS). Assessments of both MLs were graded according the following responses: 0-no wrinkles, 1-just perceptible wrinkle, 2-shallow wrinkle, 3, moderately deep wrinkle, 4-deep wrinkle, well defined edges, 5-very deep wrinkle, redundant fold. WAS improvement from baseline included 1-grade improvement (reduction in WAS) from baseline. | 42 days |
| Mean Change in Dynamic Facial Strain (Stretch) at Day 42 Compared to Baseline - NLF Combined (Global Dynamic Assessment) | Dynamic strain (stretch) results were analyzed using a Global Dynamic Assessment (GDA).The GDA averages strain (stretch) for the 4 predefined individual expressions, providing a global measure of dynamic strain (stretch), for a specific area of interest (ie, NLF). This value reflects the mean change in dynamic facial stretch at Day 42 compared to Baseline using 3D imaging. | baseline and 42 days |
| Mean Change in Dynamic Facial Strain (Stretch) at Day 42 Compared to Baseline - ML Combined (Global Dynamic Assessment) | Dynamic strain (stretch) results were analyzed using a Global Dynamic Assessment (GDA).The GDA averages strain (stretch) for the 4 predefined individual expressions, providing a global measure of dynamic strain (stretch), for a specific area of interest (ie, ML). This value reflects the mean change in dynamic facial stretch at Day 42 compared to Baseline using 3D imaging. | baseline and 42 days |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Secondary | Number of Subjects With Naturalness of Expression (Photographs) | Proportion of subjects having at least maintained naturalness of facial expression based on photograph assessment at Day 42, by treating investigator | Posted | Count of Participants | Participants | 42 days |
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| Secondary | Number of Subjects With Naturalness of Expression, Attractiveness AND Younger Appearance (2D Video) | Proportion of subjects having at least maintained naturalness of expression in the lower face (naturalness is maintained or enhanced) AND attractiveness of the lower face is enhanced AND age of the lower face is younger, based on 2D video assessment at Day 42, by the treating investigator. The is a composite perception assessment; the proportion of subjects must meet all 3 criteria (maintain naturalness, maintain attractiveness, and appear younger in the lower face. | Posted | Count of Participants | Participants | 42 days |
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| Secondary | Number of Subjects Reporting Global Improvement (Subject) | Aesthetic improvement assessed by subject using the Global Aesthetic Improvement Scale (GAIS). The subject reported GAIS assessment was based on comparing Day 42 to baseline photographs with the following ratings: Very much improved, much improved, somewhat improved, no change, and worse. A clinically significant "global" improvement was defined as a score of improved, much improved, or very much improved. | Posted | Count of Participants | Participants | 42 days |
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| Secondary | Number of Subjects Demonstrating Global Improvement (Treating Investigator) | Aesthetic improvement assessed by treating investigator using the Global Aesthetic Improvement Scale (GAIS). The treating investigator reported GAIS assessment was based on comparing Day 42 to baseline photographs with the following ratings: Very much improved, much improved, somewhat improved, no change, and worse. A clinically significant "global" improvement was defined as a score of improved, much improved, or very much improved. | Posted | Count of Participants | Participants | 42 days |
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| Secondary | Number of Subjects Reporting Satisfaction - The Overall Appearance of my Face Looks Natural | Proportion of subjects responding with Strongly Agree or Agree. Subject reported satisfaction using a 5-point Likert scale questionnaire. Responses were 1-strongly disagree, 2-disagree, 3-neutral, 4-agree, and 5-strongly agree. | Posted | Count of Participants | Participants | 42 days |
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| Secondary | Wrinkle Severity (Assess NLFs) - Proportion of Subjects With Bilateral Improvement of at Least 1 Grade in Wrinkle Severity | Wrinkle severity assessed by treating investigator at Day 15/Touch and Day 42 using the Wrinkle Severity Rating Scale (WSRS). Assessments of both NLFs were graded according the following responses: 1-absent, 2-mild, 3-moderate, 4-severe, and 5-extreme. WSRS improvement from baseline included 1-grade improvement (reduction in WSRS) from baseline. | Posted | Count of Participants | Participants | 42 days |
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| Secondary | Wrinkle Severity (Assess MLs) - Proportion of Subjects With Bilateral Improvement of at Least 1 Grade in Wrinkle Severity | Wrinkle severity assessed by treating investigator at Day 15/Touch and Day 42 using the Wrinkle Assessment Scale (WAS). Assessments of both MLs were graded according the following responses: 0-no wrinkles, 1-just perceptible wrinkle, 2-shallow wrinkle, 3, moderately deep wrinkle, 4-deep wrinkle, well defined edges, 5-very deep wrinkle, redundant fold. WAS improvement from baseline included 1-grade improvement (reduction in WAS) from baseline. | Posted | Count of Participants | Participants | 42 days |
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| Secondary | Mean Change in Dynamic Facial Strain (Stretch) at Day 42 Compared to Baseline - NLF Combined (Global Dynamic Assessment) | Dynamic strain (stretch) results were analyzed using a Global Dynamic Assessment (GDA).The GDA averages strain (stretch) for the 4 predefined individual expressions, providing a global measure of dynamic strain (stretch), for a specific area of interest (ie, NLF). This value reflects the mean change in dynamic facial stretch at Day 42 compared to Baseline using 3D imaging. | Posted | Mean | Standard Deviation | Percent of Stretch | baseline and 42 days |
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| Secondary | Mean Change in Dynamic Facial Strain (Stretch) at Day 42 Compared to Baseline - ML Combined (Global Dynamic Assessment) | Dynamic strain (stretch) results were analyzed using a Global Dynamic Assessment (GDA).The GDA averages strain (stretch) for the 4 predefined individual expressions, providing a global measure of dynamic strain (stretch), for a specific area of interest (ie, ML). This value reflects the mean change in dynamic facial stretch at Day 42 compared to Baseline using 3D imaging. | Posted | Mean | Standard Deviation | Percent of Stretch | baseline and 42 days |
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| 0 |
| 30 |
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| 30 |
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