Safety and Efficacy of Treatment With Azzalure, Restylane/Emervel Filler and Restylane Skinbooster

An Evaluator-blinded Multi-center Study of Combined Treatment With Azzalure, Restylane/Emervel Filler and Restylane Skinbooster as Compared to Single Treatment With Either Azzalure Alone or Restylane/Emervel Filler Alone

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.

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.