title: A two-stage phase I trial of Evolence30 collagen for soft-tissue contour correction.
abstract: BACKGROUND
  The ideal dermal filler should be nonpermanent but with a durable effect lasting between 1 and 2 years, which is not the case with the resorbable fillers that are currently available. Evolence30 is a new, porcine-derived collagen gel based on the Glymatrix cross-linking technology, which results in a more natural and longer-lasting collagen product.
  
  
  METHODS
  In this first clinical trial of Evolence30 (30 mg/ml), the safety and efficacy of this new filler were tested and compared with those of Zyplast (bovine cross-linked) collagen, after treatment of nasolabial folds in 12 volunteers. Safety assessments included two hypersensitivity tests, physical examination of injections sites, punch biopsies for histopathology, adverse events, and blood sample analysis. The seven-grade, validated Modified Fitzpatrick Wrinkle Scale was used by three independent blinded assessors to evaluate efficacy.
  
  
  RESULTS
  No treatment-related adverse events were reported. Only transient erythema was observed in both treated sides, and there were no abnormal laboratory findings. None of the sera contained immunoglobulin (Ig) M, IgA, or IgE antibodies against porcine collagen at any time during the study. Initially, Evolence30 and Zyplast improved wrinkle severity to a similar extent. However, in an average follow-up of 18 months, assessment by the blinded assessors showed that the treatment effect on the Evolence30-treated side was superior in 9 of the 11 participants who were treated (p = 0.022).
  
  
  CONCLUSIONS
  Evolence30 is a new, porcine-derived collagen product based on the Glymatrix cross-linking technology that enables a safe and effective correction of the nasolabial folds. This correction lasts significantly longer than that with Zyplast.
authors.affiliation: Gent, Belgium; and Tel Aviv, Ramat-Gan, and Herzliya, Israel From the Department of Plastic Surgery, University Hospital Gent; Department of Oral Biology, Goldschleger School of Dental Medicine, Sackler Faculty of Medicine, Tel Aviv University; Esthetic Dermatology Unit, Sheba Medical Center; and ColBar LifeScience.
authors.forename: Stan J
authors.initials: SJ
authors.lastname: Monstrey
authors.forename: Sandu
authors.initials: S
authors.lastname: Pitaru
authors.forename: Moustapha
authors.initials: M
authors.lastname: Hamdi
authors.forename: Koen
authors.initials: K
authors.lastname: Van Landuyt
authors.forename: Phillip
authors.initials: P
authors.lastname: Blondeel
authors.forename: Joseph
authors.initials: J
authors.lastname: Shiri
authors.forename: Arie
authors.initials: A
authors.lastname: Goldlust
authors.forename: David
authors.initials: D
authors.lastname: Shoshani
mesh_terms: D000368:Aged; D003094:Collagen / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D004954:Esthetics; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage* / Q000009:adverse effects; D007271:Injections, Intradermal; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D011336:Probability; D012060:Rejuvenation; D012307:Risk Factors; D015595:Skin Aging / Q000187:drug effects*; D018709:Statistics, Nonparametric; D016896:Treatment Outcome
chemical_list: C502935:Perlane; C048470:glutaraldehyde-cross-linked collagen; D006820:Hyaluronic Acid; D003094:Collagen