Trial Outcomes & Findings for Emervel for the Correction of Lower Face Wrinkles & Folds (NCT NCT02718040)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

30 participants

Primary outcome timeframe

42 days

Results posted on

2022-08-01

Participant Flow

Participant milestones

Participant milestones
Measure	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)
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Emervel for the Correction of Lower Face Wrinkles & Folds

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Emervel Treatment Group n=30 Participants 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)
Age, Continuous	55.0 Years STANDARD_DEVIATION 6.01 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Canada	30 Participants n=5 Participants

PRIMARY outcome

Timeframe: 42 days

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

Outcome measures

Outcome measures
Measure	Emervel Treatment Group n=30 Participants 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)
Number of Subjects With Naturalness of Expression in Motion (2D Video)	30 Participants

SECONDARY outcome

Timeframe: 42 days

Proportion of subjects having at least maintained naturalness of facial expression based on photograph assessment at Day 42, by treating investigator

Outcome measures

Outcome measures
Measure	Emervel Treatment Group n=30 Participants 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)
Number of Subjects With Naturalness of Expression (Photographs)	28 Participants

SECONDARY outcome

Timeframe: 42 days

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.

Outcome measures

Outcome measures
Measure	Emervel Treatment Group n=30 Participants 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)
Number of Subjects With Naturalness of Expression, Attractiveness AND Younger Appearance (2D Video)	25 Participants

SECONDARY outcome

Timeframe: 42 days

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.

Outcome measures

Outcome measures
Measure	Emervel Treatment Group n=30 Participants 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)
Number of Subjects Reporting Global Improvement (Subject)	30 Participants

SECONDARY outcome

Timeframe: 42 days

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.

Outcome measures

Outcome measures
Measure	Emervel Treatment Group n=30 Participants 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)
Number of Subjects Demonstrating Global Improvement (Treating Investigator)	30 Participants

SECONDARY outcome

Timeframe: 42 days

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.

Outcome measures

Outcome measures
Measure	Emervel Treatment Group n=30 Participants 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)
Number of Subjects Reporting Satisfaction - The Overall Appearance of my Face Looks Natural	30 Participants

SECONDARY outcome

Timeframe: 42 days

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.

Outcome measures

Outcome measures
Measure	Emervel Treatment Group n=30 Participants 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)
Wrinkle Severity (Assess NLFs) - Proportion of Subjects With Bilateral Improvement of at Least 1 Grade in Wrinkle Severity	30 Participants

SECONDARY outcome

Timeframe: 42 days

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.

Outcome measures

Outcome measures
Measure	Emervel Treatment Group n=30 Participants 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)
Wrinkle Severity (Assess MLs) - Proportion of Subjects With Bilateral Improvement of at Least 1 Grade in Wrinkle Severity	30 Participants

SECONDARY outcome

Timeframe: baseline and 42 days

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.

Outcome measures

Outcome measures
Measure	Emervel Treatment Group n=30 Participants 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)
Mean Change in Dynamic Facial Strain (Stretch) at Day 42 Compared to Baseline - NLF Combined (Global Dynamic Assessment)	-1.836 Percent of Stretch Standard Deviation 2.1025

SECONDARY outcome

Timeframe: baseline and 42 days

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.

Outcome measures

Outcome measures
Measure	Emervel Treatment Group n=30 Participants 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)
Mean Change in Dynamic Facial Strain (Stretch) at Day 42 Compared to Baseline - ML Combined (Global Dynamic Assessment)	-2.209 Percent of Stretch Standard Deviation 2.8716

Adverse Events

Emervel Treatment Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jay Mashburn

Galderma Laboratories

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place