A randomized, double-blind, multicenter comparison of the efficacy and tolerability of Restylane versus Zyplast for the correction of nasolabial folds.
BACKGROUND
Bovine collagen is extensively used for facial soft tissue augmentation but provides only temporary correction and can cause hypersensitivity reactions. Hyaluronic acid derivatives potentially offer improved longevity of correction and a reduced risk of immunogenicity and hypersensitivity.


OBJECTIVE
To compare the efficacy and safety of nonanimal stabilized hyaluronic acid gel (Restylane; Q-Med, Uppsala, Sweden) with that of bovine collagen (Zyplast) for treatment of nasolabial folds.


METHODS
One hundred thirty-eight patients with prominent nasolabial folds were randomized to treatment with hyaluronic acid gel and bovine collagen on contralateral sides of the face. Treatments were repeated at 2-week intervals, as required, to achieve "optimal cosmetic result" (baseline). Outcomes were evaluated by a blinded investigator at 2, 4, and 6 months after baseline.


RESULTS
Less injection volume was required for "optimal cosmetic result" with hyaluronic acid gel than with bovine collagen, and patients and investigators judged hyaluronic acid gel to be more effective in maintaining cosmetic correction. The investigator-based Wrinkle Severity Rating Scale and Global Aesthetic Improvement Scale assessments at 6 months after baseline indicated that hyaluronic acid gel was superior in 56.9% and 62.0% of patients, respectively, whereas bovine collagen was superior in 9.5% and 8.0% of patients, respectively. The frequency, intensity, and duration of local injection-site reactions were similar for the two products.


CONCLUSIONS
Nonanimal stabilized hyaluronic acid provides a more durable aesthetic improvement than bovine collagen and is well tolerated.
Narins
Rhoda S
RS
Dermatology and Laser Center, White Plains, New York, USA. rsnmd@worldnet.att.net
Brandt
Fredric
F
Leyden
James
J
Lorenc
Z Paul
ZP
Rubin
Mark
M
Smith
Stacy
S
D000328:Adult; D000368:Aged; D001672:Biocompatible Materials / Q000008:administration & dosage*; D003094:Collagen / Q000008:administration & dosage*; D003357:Cosmetic Techniques; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D007271:Injections, Intradermal; D008046:Lip; D008297:Male; D008875:Middle Aged; D009666:Nose; D019736:Prostheses and Implants; D015595:Skin Aging / Q000187:drug effects*; D013997:Time Factors; D016896:Treatment Outcome
D001672:Biocompatible Materials; C048470:glutaraldehyde-cross-linked collagen; D006820:Hyaluronic Acid; D003094:Collagen; C445361:Restylane