Skin test hypersensitivity study of a cross-linked, porcine collagen implant for aesthetic surgery.
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.


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.


CONCLUSIONS
Because the EVOLENCE implant has a low potential for hypersensitivity, intradermal skin testing before its use appears unnecessary.
Shoshani
David
D
ColBar LifeScience Ltd, Herzliya, Israel. DShoshani@colil.jnj.com
Markovitz
Elana
E
Cohen
Yael
Y
Heremans
Annie
A
Goldlust
Arie
A
D000328:Adult; D000818:Animals; D001672:Biocompatible Materials / Q000008:administration & dosage*; D003094:Collagen / Q000008:administration & dosage / Q000276:immunology*; D003357:Cosmetic Techniques; D003432:Cross-Linking Reagents; D004342:Drug Hypersensitivity / Q000175:diagnosis* / Q000209:etiology; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D005542:Forearm; D006801:Humans; D007267:Injections; D008297:Male; D012882:Skin Tests; D013535:Suspensions; D013552:Swine
D001672:Biocompatible Materials; D003432:Cross-Linking Reagents; D013535:Suspensions; D003094:Collagen