Preliminary Safety Evaluation of RPC Pure-Collagen

• Research type

  Research Study

• Full title

  Evaluation of the Safety and Tolerability of a Novel, Porcine Collagen-Based Composition Intended for Use to Treat Mild to Severe Facial Wrinkles and Folds

• IRAS ID

  138810

• Contact name

  Christopher Inglefield

• Contact email

  chris@lbps.co.uk

• Sponsor organisation

  EternoGen

• 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. While overall demand has diminished for the reasons discussed above, there is still a desire to identify a versatile collagen-based filler with an exceptional safety profile and longevity equal to today’s hyaluronic acid products. RPC Pure Collagen appears to meet these requirements. The purpose of the pilot clinical study described herein is to evaluate the safety and tolerability of a novel, porcine collagen-based composition (“RPC Pure-Collagen”) intended for used to treat mild to severe facial wrinkles and folds including nasolabial folds. RPC Pure Collagen is supplied as a clear, viscous gel that can be injected through 30 Gauge needles and cannula. In preclinical animal studies, RPC Pure-Collagen was shown to be durable up to 6 months.
  This is a prospective, single-center, dual-phase open-label study to evaluate the safety and tolerability of RPC Pure-Collagen. In phase I, the safety of RPC Pure-Collagen will be evaluated following skin testing in the back or forearms of subjects. Injection sites in the lower back and forearm will be visually examined for erythema, edema and/or ulceration at 3-5 days, and at 4 weeks. At week 4, biopsies will be removed from subjects receiving injections into the lower back and histologically examined for inflammatory markers. Injection sites on the forearm will be visually examined at 28 days (4 weeks) for indications of hypersensitivity. Subjects showing no signs of hypersensitivity either in the back or forearm may continue participation in Phase II of the study. In Phase II, subjects will receive RPC Pure-Collagen injections into the nasolabial area followed by evaluation at 1, 4, 8 and 12 weeks.

• REC name

  London - Stanmore Research Ethics Committee

• REC reference

  13/LO/1661

• Date of REC Opinion

  10 Dec 2013

• REC opinion

  Further Information Favourable Opinion