An Efficacy and Safety Study Evaluating Treatment Sessions of Restylane Skinboosters Vital Lidocaine in the Face
Condition: Aged Skin
Intervention: Restylane Vital Skinboosters Lidocaine
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 53.0
Sex: Female
Minimum age: 35 Years
Maximum age: 45 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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.