Emervel for the Correction of Lower Face Wrinkles & Folds
Condition: Nasolabial Folds; Marionette Lines; Wrinkles
Intervention: Emervel Classic and/or Deep Treatment Group
Intervention description: 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)
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: Female
Minimum age: 40 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

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.