Study to Evaluate Efficacy, Safety and Injection Technique of Restylane Lip Volume and Restylane Lip Refresh

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 two new Restylane Lip products, Restylane Lip Volume and Restylane Lip Refresh, and to collect information on the injection technique.

Detailed Description
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Restylane Lip Volume is intended to be used for lip enhancement and Restylane Lip Refresh is intended to restore hydrobalance and improve skin structure of the lips (referred to as lip rejuvenation in this protocol), respectively. The lidocaine content is designed to reduce the subject's pain during treatment. The objectives of this open, multicenter study are to evaluate efficacy and safety of the products for the studied indications and to collect information on injection techniques used.

Official Title
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An Open, Multi-center Study Evaluating Efficacy, Safety and Injection Technique of Restylane Lip Products for Lip Enhancement and Lip Rejuvenation

Conditions
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Injection Techniques

Intervention / Treatment
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* Device: Restylane Lip Volume
* Device: Restylane Lip Refresh


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 60 years of age. Intent to undergo lip augmentation or rejuvenation of both the upper and lower lip. Signed informed consent. Exclusion Criteria: 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. A history of herpes labialis and an outbreak within four weeks of study entry or with four or more outbreaks in the 12 months prior to study entry. Presence of facial hair that may interfere with efficacy evaluations. 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 hyaluronic acid or local anesthetics. Concomitant anticoagulant therapy and therapy with inhibitors of platelet aggregation within 10 days prior to treatment, or a history of bleeding disorders. Cancerous or pre-cancerous lesions in the area to be treated. Previous tissue augmenting therapy in the area to be treated with hyaluronic acid (HA) or collagen filler, or laser treatment, during the last 12 months. Permanent implant placed in the area to be treated or treatment with non-HA or non-collagen filler in the area to be treated. Pregnancy or breast feeding. Participation in any other clinical study within 30 days prior to 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: 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Restylane Lip Volume<br>Submucosal injections with Restylane Lip Volume. Treatment of up to 1,5 ml product for upper and lower lip, respectively at week 0 and optional at week 2 and 12. | Device: Restylane Lip Volume<br>* Treatment of up to 1,5 ml product for upper and lower lip, respectively at week 0 and optional at week 12.<br>|
| Experimental: Restylane Lip Refresh<br>Submucosal injections with Restylane Lip Refresh. Treatment of up to 0,5 ml product for upper and lower lip, respectively at week 0 and optional at week 2 and 12. | Device: Restylane Lip Refresh<br>* Treatment of up to 0,5 ml product for upper and lower lip, respectively at week 0 and optional at week 12.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GEIS (Global Esthetic Improvement Scale) Assessed by the Subject at Week 8 After Treatment | To evaluate esthetic change of lips from baseline as judged by the subjects using GEIS. GEIS is a categorical scale with five levels: very much improved, much improved, somewhat improved, no change, worse. | At week 8 - change of lips from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GEIS (Global Esthetic Improvement Scale) Assessed by the Subject at Week 36 After Treatment | To evaluate esthetic change of lips from baseline as judged by the subjects using GEIS at week 36. GEIS is a categorical scale with five levels: very much improved, much improved, somewhat improved, no change, worse. | week 36 - change from baseline | 
| GEIS (Global Esthetic Improvement Scale) Assessed by the Treating Investigator at Week 36 After Treatment | To evaluate esthetic change of lips from baseline as judged by the treating investigator using GEIS at week 36. GEIS is a categorical scale with five levels: very much improved, much improved, somewhat improved, no change. | week 36 - change from baseline | 
| GEIS (Global Esthetic Improvement Scale) Assessed by the Independent Evaluator at Week 36 After Treatment | To evaluate esthetic change of lips from baseline as judged by the independent evaluator using GEIS at week 2, 4, 12, 26 and 36. GEIS is a categorical scale with five levels: very much improved, much improved, somewhat improved, no change, worse. | week 36 - change from baseline | 
| MLFS (Medicis Lip Fullness Scale) at Week 8 | To evaluate the efficacy in terms of Medicis Lip Fullness Scale (MLFS) score by live assessment performed separately by the treating and the independent investigators in the Restylane Lip Volume group. The scale has five levels: Very thin, thin, median, full, very full. Treatment success is defined as at least one grade increase. | week 8 - change from baseline | 
| Subject Satisfaction Questionnaire | To evaluate subjects satisfaction in terms of a subject satisfaction questionnaire at week 8 after treatment. The subject satisfaction questionnaire consists of questions regarding the looks, appearance, disomfort, and satisfaction regarding the treatment of the lips. The question that will be referred to is: How satisfied are you today with (the look of) your lips ? | Week 8 | 
| Subject Diary for 14 Days After Initial Treatment | To evaluate the acute safety profile (bruising, itching, pain, redness, swelling and tenderness) in terms of a 14-day subject diary after initial treatment. Subjects still reporting one or more of the symptoms; bruising, itching, pain, redness, swelling and tenderness in the diary at day 14. | 2 weeks after initial treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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efficacy, safety, Restylane, Lip products, injection techniques