Perception of Facial Expressions Following Correction of Wrinkles and Folds

Study Overview
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Brief Summary
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The purpose of this study is 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.

Official Title
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A Multi-center, Non-comparative 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

Conditions
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Wrinkles and Folds in Lower Face

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent NLFs assessed as moderate of severe using the WSRS Intent to undergo optimal correction of both NLFs Intent to undergo correction of at least one other wrinkle or fold in the lower face 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 Subject who presents with severe midface volume loss Subject who presents with facial hair, e.g. beard, moustache, in the treatment area Woman who is pregnant or breast feeding or plans to become pregnant during the study 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 Previous surgery, including aesthetic facial surgical therapy, liposuction or tattoo, in the treatment area Previous tissue augmenting therapy or contouring with permanent filler or fat-injection below the zygomatic arch Previous tissue augmenting therapy, contouring or revitalisation treatment with non-HA filler, e.g. Calcium Hydroxyapatite (CaHa), or Poly L-Lactic Acid (PLLA), below the zygomatic arch within 24 months before treatment Previous tissue augmenting therapy, contouring or revitalisation treatment with non-permanent filler below the zygomatic arch within 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 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)

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intradermal injection<br>Emervel Classic Lidocaine and/or Emervel Deep Lidocaine | Device: Emervel Classic Lidocaine<br>* Treatment of wrinkles and folds<br>Device: Emervel Deep Lidocaine<br>* Treatment of wrinkles and folds<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment impact on facial expressions | Perception of naturalness | 1 month after touch-up treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety by assessment of local tolerability |  | 2 weeks after first treatment | 
| Safety by assessment of Adverse Events |  | 0-13 months | 
| Treating investigator satisfaction with treatment outcome | Questionnaire | 1 month after touch-up | 
| Subject satisfaction with treatment outcome | Questionnaires | 1 month after touch-up | 
| Nasolabial fold severity | WSRS photo scale | Before treatment and 2 weeks after first treatment and 1 month after touch-up | 
| Aesthetic improvement of lower face | GAIS | 1 month after touch-up |