Two Formulations of ELAPR Compared to Restylane® Vital Light Following Repeat Implants in the Upper Arm Dermis

Exclusion Criteria

• •Clinically significant abnormalities of haematology or biochemistry testing
• •Bleeding diathesis
• •anticoagulant drugs
• •thrombocytopenia or clinically significant prolonged APTT or PT
• •Chronic use of aspirin, other non-steroidal anti-inflammatory drugs or other anti-platelet agents
• •History of keloid formation
• •Systemic corticosteroids within last 12 weeks
• •Diabetes or other metabolic disorders that may interfere with the subject's response to treatment in the opinion of the investigator
• •Any serious medical condition which in the opinion of the investigator would have a strong possibility of requiring systemic corticosteroid medication
• •Pregnancy/lactation
• •Previously received Tropoelastin
• •A history of anaphylaxis or allergic reactions including any known hypersensitivity to Hyaluronic acid or lidocaine
• •Sensitivity to Restylane® Vital light or Restylane products
• •Use of any other investigational product on the intended implant site in the previous 12 months.
• •Sensitivity to topical local anaesthetic cream (EMLA®) or have the following conditions where EMLA is contraindicated: dermatitis, Methaemoglobinaemia, Glucose-6-phosphate dehydrogenase deficiency or "Mollusca Contagiosa"