Safety and Efficacy of Treatment With Azzalure, Restylane/Emervel Filler and Restylane Skinbooster
Condition: Facial Aesthetic Treatment
Intervention: Azzalure; Restylane/Emervel filler; Restylane Skinbooster
Intervention description: Glabellar lines; Facial tissue augmentation; Facial skin rejuvenation
Intervention MeSH terms: Botulinum Toxins; abobotulinumtoxinA; Hyaluronic Acid
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Minimum age: 35 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The efficacy and safety, as well as subject satisfaction will be evaluated after single
      treatment with Azzalure alone or Restylane/Emervel filler alone followed by repeated combined
      treatment with Azzalure, Restylane/Emervel filler and Restylane Skinbooster. Subjects will be
      followed for up to 18 months after initial treatment.
    

Eligibility criteria:

        Inclusion Criteria

          -  Subjects aged 35 to 50 years old

          -  Subjects with the intention to undergo facial aesthetic treatment and who are likely
             to benefit from a combination of injection treatments and the benefit can be shown by
             improvements in their global facial aesthetic appearance and satisfaction.

          -  Subjects with nasolabial folds assessed as mild or moderate.

          -  Subjects with glabellar lines assessed as moderate or severe, when the severity of the
             lines has an important psychological impact on the subject.

          -  Subjects with signed informed consent.

        Exclusion Criteria:

          -  Subjects requiring treatment of forehead lines or crow´s feet.

          -  Obvious facial sagging (major loss of facial fat/volume).

          -  Signs or symptoms of eyelid ptosis or signs of compensatory frontalis muscle activity.

          -  Heavily scarred or sun-damaged facial skin.

          -  Active skin disease, inflammation or related conditions, such as infection, psoriasis
             and herpes zoster/herpes simplex near or on the areas to be treated.

          -  Cancerous or pre-cancerous lesions in the areas to be treated.

          -  Facial tissue augmenting therapy or revitalization treatment with hyaluronic acid (HA)
             or collagen, or botulinum toxin treatment during the last 12 months.

          -  Procedures or treatments inducing an active dermal response such as laser, Intense
             Pulsed Light, chemical peeling, microdermabrasion, retinoids within the last 6 months.

          -  Any aesthetic surgery of the face.

          -  Permanent implant or aesthetic treatment with non-HA or non-collagen products in the
             face.

          -  History of severe keloids and/or hypertrophic scars.

          -  Neuromuscular junctional disorders (e.g. myasthenia gravis, Eaton Lambert syndrome or
             amyotrophic lateral sclerosis) or history of dysphagia and aspiration.

          -  Known hypersensitivity to hyaluronic acid, botulinum toxin, lidocaine hydrochloride or
             other amide-type anesthetics.

          -  History of autoimmune diseases.

          -  Any medical condition that in the opinion of the investigator would make the subject
             unsuitable for inclusion (e.g. a chronic, relapsing or hereditary disease that may
             affect the general condition or may require frequent medical treatment).

          -  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.

          -  Immunosuppressive therapy, chemotherapy, or systemic corticosteroids within the last 3
             months prior to baseline visit.

          -  Female subjects who are pregnant or plan to become pregnant within the study
             timeframe, or who are nursing.