Skin Test Hypersensitivity Study of a Cross-linked, Porcine Collagen Implant for Aesthetic Surgery

Abstract

BACKGROUND The use of bovine collagen implants for dermal contour correction is associated with a 3% to 5% incidence of hypersensitivity, which necessitates pretreatment screening by an intradermal skin test. OBJECTIVE The objective was to determine the incidence of hypersensitivity with the recently developed cross‐linked, porcine collagen implant, EVOLENCE (ColBar LifeScience Ltd.), which is used intradermally for correction of rhytids and scars. MATERIALS AND METHODS Enrolled subjects (n=530) received an intradermal injection of 0.1 mL EVOLENCE implant in the left forearm and a second injection in the right forearm after 2 weeks. Injection sites were assessed clinically at 30 minutes and 72 hours after each injection and at 30 days after the second injection. Serum anticollagen antibody determinations were performed at screening and at the end of the study. RESULTS Study assessments were completed by 519 subjects. No significant erythematous reactions suggestive of positive hypersensitivity were observed. Most subjects did not display antibodies against porcine Type I collagen at any time, and those who did showed no changes in levels during the study. The single‐sided 95% upper confidence limit for the possibility of moderate‐to‐severe erythematous reactions with the EVOLENCE implant was determined as 0.58% of subjects. CONCLUSION Because the EVOLENCE implant has a low potential for hypersensitivity, intradermal skin testing before its use appears unnecessary.

The Biology of Facial Fillers

“…2,37 Because it so closely resembles human collagen and because the N-terminals are removed in the production process, it should have significantly decreased immunogenicity. 2,38 In a study of 519 patients, there were no hypersensitivity reactions. 38 There is not currently a large number of long-term studies available.…”

“…2,38 In a study of 519 patients, there were no hypersensitivity reactions. 38 There is not currently a large number of long-term studies available. In one small study comparing Evolence with Zyplast (12 patients), there was better persistence of Evolence at 18 months and no elevation of immunoglobulins during the study.…”

“…The incidence of allergic reaction to skin tests is 3 to 5%. 2,32,38 During its purification and manufacturing process, cleavage of many of the telopeptides decreases but does not eliminate its immunogenicity. 32,36 To the extent that cross-linking decreases the number of telopeptides, it may also decrease the immunogenicity, 33 but this has not been proved definitively.…”

Expert guideline on the use of porcine collagen in aesthetic medicine

“…However the sold product is still widely available and will continue to be used in the next couple of years. These porcine products differ from bovine collagen products in being significantly less allergenic [1] and possessing longer stability after injection. A sugar molecule (ribose) is employed for cross‐linking instead of a chemical stabilizer [2].…”

Efficacy and Tolerability of Admixing 0.3% Lidocaine with Dermicol-P35 27G for the Treatment of Nasolabial Folds

“…Dermicol‐P35 27G (Evolence, Ortho Dermatologics Inc., Los Angeles, CA) is a type I porcine collagen–based dermal filler that is ribose cross‐linked using patented Glymatrix technology 5 . Dermicol‐P35 27G is durable, 6,7 does not have the toxicity associated with glutaraldehyde, and has a low potential for hypersensitivity 8 . In a randomized, multicenter study, Dermicol‐P35 27G was as effective as non‐animal‐stabilized hyaluronic acid for reducing the Modified Fitzpatrick Wrinkle Scale (MFWS) score in the treatment of nasolabial folds (NLFs) 5 .…”