Clinical trial NCT02718040: Emervel for the Correction of Lower Face Wrinkles & Folds
Official title: A Multi-Center Study to Evaluate the Perception of Facial Expressions Following Correction of Wrinkles and Folds in the Lower Face Using Emervel® Classic Lidocaine and Emervel® Deep Lidocaine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nasolabial Folds
Marionette Lines
Wrinkles
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2016-03-24
Enrollment: 30
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to

1. evaluate the naturalness of facial expressions in motion (2D video images), by treating investigator assessment
2. evaluate naturalness of facial expressions (photographs), by treating investigator assessment
3. evaluate perceived attractiveness and age of subject (2D videos), by treating investigator assessment
4. evaluate aesthetic improvement, by subject and treating investigator assessments
5. evaluate subject satisfaction
6. evaluate nasolabial fold (NLF) severity, by treating investigator assessment
7. evaluate marionette lines (MLs) severity, by treating investigator assessment
8. evaluate dynamic facial strain in animation using 3D digital photogrammetric analysis
9. evaluate all adverse events reported during the study.


Eligibility criteria: Key Inclusion Criteria:

1. Seeking correction of bilateral NLFs: severe (i.e., bilateral WSRS = 3-4) or moderate (i.e., bilateral WSRS = 2-3) AND bilateral MLs: severe (i.e., WAS = 3-4) or moderate (i.e., WAS = 2-3).
2. Subjects of childbearing potential who agree to use medically accepted methods of contraception during the study and for 30 days following study completion.
3. Intent to undergo optimal correction of bilateral NLFs and MLs. Optimal correction is defined as the best possible aesthetic outcome as agreed to by the treating investigator and subject.

Key Exclusion Criteria:

1. Subject who presents with a severity of wrinkles or folds that require other treatments, e.g. laser treatment, chemical peeling, to achieve optimal correction.
2. Previous facial surgery, including aesthetic facial surgical therapy, liposuction or tattoo, in the treatment area.
3. Previous tissue augmenting therapy or contouring with permanent or non-permanent filler or fat-injection in the facial area.
4. Previous tissue revitalization treatment with neurotoxin in the facial area within 6 months before treatment.
5. Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel.
6. Known/previous allergy or hypersensitivity to local anaesthetics, e.g. lidocaine or other amide-type anaesthetics.
7. Known/previous allergy or hypersensitivity to gram-positive bacterial proteins.
8. Any medical condition that, in the opinion of the treating investigator, would make the subject unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease that may interfere with the outcome of the study).
9. Other condition preventing the subject from entering the study in the treating investigator's opinion, e.g. subjects not likely to avoid other facial cosmetic treatments, subjects anticipated to be unreliable, unavailable or incapable of understanding the study assessments or having unrealistic expectations of the treatment result.

Primary outcomes:
measure: Number of Subjects With Naturalness of Expression in Motion (2D Video)
timeFrame: 42 days
Secondary outcomes:
measure: Number of Subjects With Naturalness of Expression (Photographs)
timeFrame: 42 days
measure: Number of Subjects With Naturalness of Expression, Attractiveness AND Younger Appearance (2D Video)
timeFrame: 42 days
measure: Number of Subjects Reporting Global Improvement (Subject)
timeFrame: 42 days
measure: Number of Subjects Demonstrating Global Improvement (Treating Investigator)
timeFrame: 42 days
measure: Number of Subjects Reporting Satisfaction - The Overall Appearance of my Face Looks Natural
timeFrame: 42 days
measure: Wrinkle Severity (Assess NLFs) - Proportion of Subjects With Bilateral Improvement of at Least 1 Grade in Wrinkle Severity
timeFrame: 42 days
measure: Wrinkle Severity (Assess MLs) - Proportion of Subjects With Bilateral Improvement of at Least 1 Grade in Wrinkle Severity
timeFrame: 42 days
measure: Mean Change in Dynamic Facial Strain (Stretch) at Day 42 Compared to Baseline - NLF Combined (Global Dynamic Assessment)
timeFrame: baseline and 42 days
measure: Mean Change in Dynamic Facial Strain (Stretch) at Day 42 Compared to Baseline - ML Combined (Global Dynamic Assessment)
timeFrame: baseline and 42 days
Other outcomes:
Locations:
Study officials:
affiliation: Galderma Laboratories
name: Jay Mashburn
role: STUDY_DIRECTOR
References: