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

A Phase 1B Study to Assess the Safety and Efficacy of Two Formulations of ELAPR Compared to Restylane® Vital Light Following Repeat Implants in the Upper Arm Dermis

This is an early phase study comparing two fixed dose of the study compound ELAPR and a Restylane® Vital Light (control), by multiple intradermal injections to a 3cm x 3cm area of the upper arm dermis. All subjects will receive three treatments, 3 weeks apart. Each treatment will consist of 16 injections in total, each 10mm apart in a grid formation over a 3cm x 3cm area of the mid - to deep dermis of the medial aspect of the upper arm. Each injection will consist of 20-30ul of product delivered using a 30Gx¼" needle.

Each subject will also receive Restylane® Vital Light (control) to the opposite arm following the same treatment regimen and using the same technique. A 4mm skin biopsy will be taken from each of the implant sites from Cohort A subjects (including replacements) on Day 169, and from Cohort B subjects (including replacements) on Day 85. The biopsy will encompass the needle point tattoo at the centre of the implant site. The biopsy site will be closed with a single stitch followed by standard aftercare procedures with stitch removal 7 to 10 days later.

Inclusion Criteria:

• Age 35 to 50 years
• Male or Female
• Good general health status
• Able to give informed consent

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"