Safety and Efficacy of Lip Injections With Emervel Lips and Juvederm Ultra Smile

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate the efficacy and safety of Emervel Lips and Juvederm Ultra smile

Official Title
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A Randomised, Evaluator-blinded, Comparative Study of the Safety and Efficacy of Lip Injections With Emervel Lips and Juvederm Ultra Smile

Conditions
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Local Tolerability After Lip Filler Injections

Intervention / Treatment
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* Device: Emervel Lips
* Device: Juvederm Ultra Smile


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female subjects aged 18 to 65 years. Subjects with the intention to undergo lip augmentation treatment. Subjects treatment-naïve for lip augmentation treatment Subjects with lip appearance judged by the treating investigator to be suitable for lip line treatment Subjects with signed informed consent. Exclusion Criteria: Concomitant anticoagulant therapy and therapy with inhibitors of platelet aggregation (e.g. aspirin or other nonsteroidal anti-inflammatory drugs [NSAIDs]), Omega-3 or vitamin E within 10 days before study treatment, or a history of bleeding disorders. Prior surgery or tattoo to the upper or lower lip or lip line. Presence of any abnormal lip structure, such as a scar or lump or severe lip asymmetry. Previous tissue augmenting therapy in the lip area (including oral commissures, marionette and perioral lines) with HA or collagen filler, or laser treatment, within 12 months before study entry. Permanent implant or treatment with non-HA or non-collagen filler in the area surrounding the lips (including nasolabial folds, oral commissures, marionette and perioral lines). History of herpes labialis with an outbreak within 4 weeks of study entry or with 4 or more outbreaks in the 12 months before study entry. Active skin disease, inflammation or related conditions, such as infection, psoriasis and herpes zoster near or on the area to be treated. History of angioedema. Previous hypersensitivity to HA. Previous hypersensitivity to lidocaine or other amide-type anaesthetics Cancerous or precancerous lesions in the area to be treated. Immunosuppressive therapy, chemotherapy, treatment with biologics or systemic corticosteroids within 3 months before study treatment. Pregnancy or breast feeding. Participation in any other clinical study within 30 days before inclusion. Other condition preventing the subject to entering the study in the investigator's opinion, e.g. subjects not likely to avoid other facial cosmetic treatments below the level of the lower orbital rim, subjects anticipated to be unreliable or incapable of understanding the study assessment or unrealistic expectations of treatment result. Study staff or close relative to study staff (e.g. parents, children, siblings or spouse).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Emervel Lips<br>Emervel Lips | Device: Emervel Lips<br>* Lip treatment of both upper and lower lip<br>|
| Experimental: Juvederm Ultra Smile<br>Juvederm Ultra Smile | Device: Juvederm Ultra Smile<br>* Lip treatment of both upper and lower lip<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local tolerability | To assess local tolerability after treatment including erythema, bruising, itching, swelling, pain/ tenderness at 14 days. Number of subjects reporting the events will be analysed. | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AE reporting | To evaluate long-term safety throughout the study period | 24 weeks | 
| Global Aesthetic Improvement Scale (GAIS) | To evaluate esthetic change of lips from baseline using GEIS | Week 2 to week 24 | 
| Lip Fullness Grading Scale (LFGS) | To evaluate esthetic change of lips from baseline using LFGS | 0-24 weeks | 
| Subject's satisfaction | To evaluate subjects satisfaction in terms of a subject satisfaction questionnaire | 0-24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lip, fillers, Hyaluronic acid