A single centre open-label study to evaluate the tolerability and safety of a synthetic injectable soft tissue implant material (Family C Matrix) in the skin of normal volunteers.

Tolerability & safety of a new synthetic soft tissue implant material consisting of Family C microspheres in hyaluronic acid carrier in the skin of healthy volunteers. The Family C implant is a thermoplastic block copolymer produced from two long-chain methacrylic aliphatic esters and one short-chain acrylic aliphatic ester. At body temperature, the material is an elastomeric solid. The Family C test article proposed will be the same material currently under evaluation per protocol D73-2602-07, yet will be provided in a microsphere form, suspended in hyaluronic acid (HA), and injected into the dermis. The implants will be delivered via a standard syringe and needle, with the assistance of an additional investigational syringe driver device. This Family C co-polymer material is now being proposed for evaluation as an injectable matrix for use in soft tissue repair or augmentation. The material is presented as microspheres in a suspension of HA. At Screening Visit (up to 30 days before Visit 1), participants will be evaluated for eligibility per the inclusion/exclusion criteria and review of their medical and dermatological history. Eligible and willing participants will review and sign the informed consent form. At Baseline – Treatment Visit 1 (Day 1), participants from whom a signed, written informed consent has been obtained and study eligibility confirmed, will be designated to receive implantation with the Test Article. Each participant will be randomly assigned to two time points for biopsy evaluation (Day 30, 90, 180, 270 or 360) of the implant material prior to placement. Two implants (~ 0.1cc) will be administered intradermally within the designated region of the inner aspect of their proximal forearm (mid-humeral area), right or left side. At the Follow-Up Visits 2, 3, 4 5, 6, 7 and 8 (Day 8, 15, 30, 60, 90, 180 or 270) participants will return to the study site for evaluation and grading of the implant sites by the Investigator per protocol. Participants will return for their Procedure Visit 1 and 2 (@ two of the randomly assigned time points; Day 30, 90, 180, 270 or 360). Each participant will have two procedure visits to remove their two implants by the investigator. Thirty (30) days after the second Procedure Visit, participants will return for post excision evaluation of the test sites. The total duration of the trial is 15 months.