An Efficacy and Safety Study Evaluating Treatment Sessions of Restylane Skinboosters Vital Lidocaine in the Face

Study Overview
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Brief Summary
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A randomised, multi-centre, parallel-group efficacy and safety study evaluating two and three initial treatment sessions of Restylane Skinboosters Vital Lidocaine in the face.

Detailed Description
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Approximately 50 female subjects shall be treated with two or three initial treatment sessions including long-term follow-up 18 months after the initial treatment regimen. Efficacy and safety to be evaluated.

Official Title
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A Randomised, Multi-centre, Parallel-group, Efficacy and Safety Study Evaluating Two and Three Initial Treatment Sessions of Restylane Skinboosters Vital Lidocaine in the Face

Conditions
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Aged Skin

Intervention / Treatment
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* Device: Restylane Vital Skinboosters Lidocaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of signed and dated informed consent to participate in the study. Non-pregnant, non-breast feeding female aged 35-45 years. Visible signs of aging in the face Intent to improve skin hydration, skin structure and the elasticity of the skin using - Restylane Skinboosters Vital Lidocaine. Exclusion Criteria: Extensively photo damaged and aged skin. Woman who plan to become pregnant during the course of the study. 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. History of severe or multiple allergies manifested by anaphylaxis. History of bleeding disorders or treatment with anticoagulants or inhibitors of platelet aggregation, Omega-3 or Vitamin E within 10 days before study treatment Treatment with chemotherapy, immunosuppressive agents, immunomodulatory therapy (e.g. monoclonal antibodies), systemic or topical (facial) corticosteroids (inhaled corticoids are allowed) within three months before study treatment. Previous tissue augmenting therapy or contouring with permanent filler or fat-injection in the face. Previous tissue augmenting therapy, contouring or revitalisation treatment with non-permanent filler, neurotoxin or revitalisation preparations (e.g. Hyal System or Restylane Skinboosters) in the face within 12 months before study treatment. Previous tissue revitalisation treatment with laser or light, radiofrequency, focused ultrasound, chemical peeling, dermabrasion, mesotherapy or any other similar treatment with influence on skin quality in the face within 6 months before study treatment. Previous aesthetic facial surgical therapy, liposuction or tattoo in the face. Previous sinus surgery or dental root surgery within 3 months before study treatment. Active skin disease, inflammation or related conditions, such as infection, perioral dermatitis, seborrheic eczema, rosacea, acne, psoriasis or herpes zoster in the face. History of or active collagen diseases or autoimmune diseases such as systemic lupus erythematosus, rheumatic arthritis, skin or systemic sclerosis. Tendency to form keloids, hypertrophic scars or any other healing disorder. History of radiation of or cancerous or pre-cancerous lesions (e.g. actinic keratosis) in the face. Use of systemic or facial topical retinoic acid within 12 months before study treatment. Nicotine use within 6 months before study treatment. (Occasional smoking, such as 1-5 cigarettes per week, or similar amount of nicotine, is allowed). Any medical condition that, in the opinion of the Investigator, would make the subject unsuitable for inclusion (e.g. chronic, relapsing or hereditary disease that may interfere with the outcome of the study. Other condition preventing the subject from entering the study in the Investigator's opinion, e.g. subjects not likely to avoid other facial aesthetic treatments, subjects anticipated to be unreliable, unavailable or incapable of understanding the study assessments or having unrealistic expectations of the treatment result. Study site personnel or close relatives of the study site personnel (e.g. parents, children, siblings and spouse) or employees at the Sponsor company. Participation in any other clinical study within 3 months before study treatment.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: R. Vital Skinboosters Lidocaine (three)<br>Treatment with three initial sessions | Device: Restylane Vital Skinboosters Lidocaine<br> <br> |
| Experimental: R. Vital Skinboosters Lidocaine (two)<br>Treatment with two initial sessions | Device: Restylane Vital Skinboosters Lidocaine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Improved Participants on the Global Aesthetic Improvement Scale (GAIS)-Subject | Subject assessment at follow-up visits of aesthetic change from baseline of the treated areas using the Global Aesthetic Improvement Scale (GAIS). GAIS is a 5-graded scale: worse; no change; improved; much improved; or very much improved. A clinically significant improvement was defined as a score of improved; much improved; or very much improved. | Baseline, 1 Month, 3 Months, 6 Months, 9 Months, 12 Months, 15 Months, 18 Months | 
| Percentage of Improved Participants on the Global Aesthetic Improvement Scale (GAIS)-Investigator | Investigator assessment at follow-up visits of aesthetic change from baseline of the treated areas using the Global Aesthetic Improvement Scale (GAIS). GAIS is a 5-graded scale: worse; no change; improved; much improved; or very much improved. A clinically significant improvement was defined as a score of improved; much improved; or very much improved. | Baseline, 1 Month, 3 Months, 6 Months, 9 Months, 12 Months, 15 Months, 18 Months |