EG-RPC-03 Pilot Safety Evaluation in Lips
Research type
Research Study
Full title
Pilot Safety Evaluation of an In Situ Polymerizing Collagen Composition for Lip Shaping and Volumization
IRAS ID
197244
Contact name
Rebecca Rone McCrate
Contact email
Sponsor organisation
EternoGen Aesthetics
Duration of Study in the UK
0 years, 11 months, 28 days
Research summary
Collagen based dermal fillers have been used extensively over the past 30+ years. For more than 20 years, collagen fillers were the "gold standard" in soft tissue augmentation. The demand for collagen-based fillers has declined and at this point, most of the collagen products are no longer commercially available. Demand has declined for several reasons including the potential risks of allergic reactions with bovine collagen, the perceived limited clinical benefit with the majority of collagen-based compositions and more importantly, the introduction of hyaluronic based products that now dominate the dermal filler markets worldwide. However, there is interest from dermatologists, plastic surgeons, and other clinicians using dermal fillers in finding a new and unique collagen-based composition that does not present a hypersensitivity risk that injects as easily as hyaluronic acid, that provides a scaffold for tissue regeneration, an that will be as durable as hyaluronic acid. RPC Pure Collagen composition aims to meet these requirements.
The purpose of the clinical study described herein is to evaluate the safety of a novel, porcine collagen-based composition (“RPC Pure-Collagen”) intended for correction of contour deficiencies and deformities in soft tissue. RPC Pure‐Collagen is recommended for the correction of fine to moderate wrinkles and/or deformities at the upper to mid dermis, depending on the lesion to be corrected. The Clinical Trial is a prospective, open label study to evaluate the safety of RPC Pure Collagen. Up to 10 subjects deformities or loss of volume in the lips will be enrolled at a center in United Kingdom. Subjects will receive RPC Pure Collagen injections into the vermillion border and/or lip body. Injection sites will be visually examined for erythema, edema and/or ulceration at 2, 6 and 12 weeks. Investigator and subject scoring as well as photographs will be recorded at these time points.REC name
London - Dulwich Research Ethics Committee
REC reference
17/LO/0460
Date of REC Opinion
29 Aug 2017
REC opinion
Further Information Favourable Opinion