Bio-Dermal Restoration with Rapidly Polymerizing Collagen: A Multicenter Clinical Study

Abstract

Background Despite the increasing popularity of facial contouring with hyaluronic acid, innovation has been limited to iterations that feature different particle sizes, concentrations, and degrees of crosslinking. Bio-dermal restoration is a new approach for correcting facial tissue defects by supplementing the natural dermal structure providing a scaffold for fibroblast adherence and proliferation. Objectives The purpose of the study was to evaluate the safety of RPC Pure-Collagen for the treatment of facial contours. Methods A prospective, multicenter, open-label study in 30 patients treated with RPC Pure-Collagen in the nasolabial fold and followed up to 12 weeks after injection. A subset of patients was further followed up to 9 months after treatment. RPC Pure-Collagen is a sterile, nonpyrogenic, viscous, clear solution composed of pure porcine collagen ethylenediamine tetraacetic acid (EDTA) and Mannitol that can be injected through a 30 gauge needle as a liquid and fibrilizes in situ forming a natural, open 3-dimensional collagen matrix for bio-dermal restoration. Results No treatment related adverse events were noted in addition to transient injection site reactions typical to injection procedures, which were mild or moderate in severity except for one case of severe bruising. There were no reports of hypersensitivity, supporting that RPC Pure Collagen does not require skin testing prior to treatment. Performance results showed a significant improvement from baseline upon treatment, and at the end of the study, on both the Merz Aesthetic Scale and the Global Aesthetic Improvement Scale assessments. Conclusions This initial study shows that RPC Pure-Collagen is safe for its use in facial contouring and provides good indication for long-term safety. Bio-dermal restoration with RPC Pure-Collagen holds promise as safe, lasting, and natural facial contouring treatment. Level of Evidence: 4