TY - JOUR
T1 - A two-stage phase I trial of evolence30 collagen for soft-tissue contour correction
AU - Monstrey, Stan J.
AU - Pitaru, Sandu
AU - Hamdi, Moustapha
AU - Van Landuyt, Koen
AU - Blondeel, Phillip
AU - Shiri, Joseph
AU - Goldlust, Arie
AU - Shoshani, David
PY - 2007/7
Y1 - 2007/7
N2 - 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. Evolence 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 Evolence (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, Evolence 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 Evolence-treated side was superior in 9 of the 11 participants who were treated (p = 0.022). CONCLUSIONS: Evolence 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.
AB - 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. Evolence 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 Evolence (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, Evolence 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 Evolence-treated side was superior in 9 of the 11 participants who were treated (p = 0.022). CONCLUSIONS: Evolence 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.
UR - http://www.scopus.com/inward/record.url?scp=34250721179&partnerID=8YFLogxK
U2 - 10.1097/01.prs.0000264402.97692.b6
DO - 10.1097/01.prs.0000264402.97692.b6
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C2 - 17572579
AN - SCOPUS:34250721179
SN - 0032-1052
VL - 120
SP - 303
EP - 311
JO - Plastic and Reconstructive Surgery
JF - Plastic and Reconstructive Surgery
IS - 1
ER -