A randomized, multicenter study of the safety and efficacy of Dermicol-P35 and non-animal-stabilized hyaluronic acid gel for the correction of nasolabial folds.
BACKGROUND
Non-animal-stabilized hyaluronic acid (NASHA) offers longer-lasting cosmetic improvement and reduced risk of hypersensitivity and requires less injection volume than bovine collagen-derived dermal fillers. Porcine collagen-derived Dermicol-P35 has low immunogenicity and has the potential to provide durability at least equivalent to that of NASHA.


OBJECTIVE
The objective was to evaluate the efficacy and safety of Dermicol-P35 and NASHA for correction of nasolabial folds (NLFs).


METHODS
A total of 149 subjects with moderate NLFs were randomized to receive Dermicol-P35 and NASHA on contralateral sides of the face. If needed, subjects could receive a repeat injection 2 weeks later to obtain an optimal cosmetic result (OCR).


RESULTS
Significant (p<.001) improvement in the Modified Fitzpatrick Wrinkle Scale scores relative to screening was observed after treatment with Dermicol-P35 and NASHA. Relative to the OCR visit, mean scores increased (p<.001) over time, but there were no significant differences between treatments (+0.39 and +0.37 at 6 months; p=.626). Greater proportions of subjects experienced swelling, bruising, and pain at the NASHA site. Several subjects had more induration at the Dermicol-P35 site. There was no evidence of any adverse immunologic effect.


CONCLUSIONS
The effectiveness of Dermicol-P35 is maintained for at least 6 months and is equivalent to NASHA for the correction of NLFs.
Narins
Rhoda S
RS
Dermatology Surgery and Laser Center, White Plains, New York 10604, USA. rsnmd@worldnet.att.net
Brandt
Fredric S
FS
Lorenc
Z Paul
ZP
Maas
Corey S
CS
Monheit
Gary D
GD
Smith
Stacy R
SR
McIntyre
Sandi
S
D000704:Analysis of Variance; D001672:Biocompatible Materials / Q000008:administration & dosage*; D003094:Collagen / Q000627:therapeutic use*; D003357:Cosmetic Techniques; D005145:Face; D005260:Female; D005782:Gels; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage* / Q000031:analogs & derivatives; D007267:Injections; D008297:Male; D018709:Statistics, Nonparametric; D016896:Treatment Outcome
D001672:Biocompatible Materials; D005782:Gels; D006820:Hyaluronic Acid; D003094:Collagen; C445361:Restylane