A two-stage phase I trial of Evolence30 collagen for soft-tissue contour correction.
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.
Monstrey
Stan J
SJ
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.
Pitaru
Sandu
S
Hamdi
Moustapha
M
Van Landuyt
Koen
K
Blondeel
Phillip
P
Shiri
Joseph
J
Goldlust
Arie
A
Shoshani
David
D
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
C502935:Perlane; C048470:glutaraldehyde-cross-linked collagen; D006820:Hyaluronic Acid; D003094:Collagen