Non-comparative Evaluation of Facial Expressions Following Lower Face Correction Using Emervel Classic and Emervel Deep

Study Overview
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Brief Summary
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Study is designed to characterize subject and treating investigator reported outcomes in the early post-treatment period, following bilateral correction of nasolabial folds using Emervel Classic and Emervel Deep. to evaluate subject-reported return to social engagement, after the initial treatment (Baseline/Day 1 visit). to evaluate change in Global Aesthetic Improvement Scale (GAIS) at day 30- subject/investigator reported to evaluate subject satisfaction with treatment outcome at baseline, day 14 and day 30. to evaluate change in Wrinkle Severity Rating Scale (WSRS) from baseline to post-treatment follow-up time points at day 14 and Day 30 - investigator reported to evaluate all adverse events during the course of the study

Official Title
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A Single-Center, Non-Comparative Study to Evaluate Subject Recovery Following Correction of Bilateral Nasolabial Folds Using Emervel® Classic Lidocaine and Emervel® Deep Lidocaine

Conditions
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Nasolabial Folds, Wrinkles

Intervention / Treatment
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* Device: Emervel Classic
* Device: Emervel Deep


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Male or female subjects, 35 to 60 years of age Bilateral NLFs: severe (WSRS = 4/4) or moderate (WSRS = 3/3), as assessed by the treating investigator Subjects of childbearing potential who agree to use medically accepted methods of contraception during the study and for 30 days following study completion. Childbearing potential is defined as not being surgically sterile (e.g., hysterectomy, bilateral salpingo-oophorectomy, or tubal ligation) or those who are not post-menopausal (absence of menstruation for at least 1 year prior to Day 1). - If not surgically sterile or post-menopausal, the subject agrees to use acceptable forms of contraception. Acceptable methods of contraception are defined as follows: use of oral/systemic contraceptives for at least 3 months prior to the start of the study; or use of an intrauterine device; or use of double barrier (e.g., condom or diaphragm and spermicidal foam/gel, condom and diaphragm); or use of contraceptive implants or injectables for at least 28 days prior to the start of the study; or partner with vasectomy at least 3 months prior to study start; or strict abstinence. Females of child bearing potential must have negative urine pregnancy test (UPT) at Day 1 and Day 14 if touch-up is to be performed. Key Exclusion Criteria: Subject who presents with a severity of wrinkles or folds that require other treatments, e.g. laser treatment, chemical peeling, to achieve optimal correction Previous facial surgery, including aesthetic facial surgical therapy, liposuction or tattoo, in the treatment area Previous tissue augmenting therapy or contouring with permanent filler-type injectable product Previous tissue augmenting therapy with non-permanent filler or fat-injection in the facial area to be treated, within twelve (12) months before treatment Previous tissue revitalisation treatment with neurotoxin below the zygomatic arch, within six (6) months before treatment Previous tissue revitalisation treatment with laser or light, mesotherapy, chemical peeling or dermabrasion below the zygomatic arch within six (6) months before treatment Subject who presents with severe midface volume loss Subject has a beard or facial hair that, in the investigator's opinion, would interfere with the study injections and/or study assessments Woman who plans to become pregnant during the study Woman who is pregnant or breast feeding Known/previous allergy or hypersensitivity to any injectable hyaluronic acid (HA) gel Known/previous allergy or hypersensitivity to local anaesthetics, e.g. lidocaine or other amide-type anaesthetics Known/previous allergy or hypersensitivity to gram-positive bacterial proteins History of severe or multiple allergies manifested by anaphylaxis History of bleeding disorders or treatment with anticoagulants or inhibitors of platelet aggregation within two (2) weeks before treatment Treatment with chemotherapy, immunosuppressive agents, immunomodulatory therapy (e.g. monoclonal antibodies), systemic or topical (facial) corticosteroids (inhaled corticoids are allowed) within three (3) months before study treatment Any medical condition or treatment that, in the opinion of the treating investigator, would make the subject unsuitable for inclusion Study site personnel, close relatives of the study site personnel (e.g. parents, children, siblings, or spouse), employees, or close relatives of employees at the Sponsor company Participation in any clinical study within thirty (30) days before treatment

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Emervel Classic<br>Subjects treated with Emervel Classic (moderate NLFs; WSRS = 3/3). Subjects receiving bilateral treatment of NLFs following approved product labeling. | Device: Emervel Classic<br>* Subjects requiring bilateral correction of NLFs and meeting eligibility criteria will be enrolled and treated with Emervel Classic (moderate NLFs; WSRS = 3/3)<br>|
| Experimental: Emervel Deep<br>Subjects treated with Emervel Deep (severe NLFs; WSRS = 4/4). Subjects receiving bilateral treatment of NLFs following approved product labeling. | Device: Emervel Deep<br>* Subjects requiring bilateral correction of NLFs and meeting eligibility criteria will be enrolled and treated with Emervel Deep (severe NLFs; WSRS = 4/4).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject-reported time of return to social engagement after initial treatment | Time of return to social engagement (in hours) | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to post-treatment follow-up time points in subject reported GAIS | Change from baseline to post-treatment follow-up time points in the subject reported GAIS (photographs) at day 30 | up to 30 days | 
| Subject satisfaction with treatment outcome of the nasolabial folds | Subject satisfaction with treatment assessments at baseline, day 14, and day 30 | 30 days | 
| Change from baseline to post-treatment follow-up time points in treating investigator reported WSRS | Change from baseline to post-treatment follow-up time points in the treating investigator reported WSRS at day 14 and day 30 | 30 days | 
| Change from baseline to post-treatment follow-up time points in treating investigator reported GAIS | Change from baseline to post-treatment follow-up time points in the treating investigator reported GAIS (photographs) at day 30 | 30 days | 
| Incidence rate of subjects with adverse events (AEs) |  | 30 days | 
| Incidence rate of subjects with injection-related adverse events | Injection-related adverse events recorded by the subject in study diary | 30 days |