12-Month controlled study in the United States of the safety and efficacy of a permanent 2.5% polyacrylamide hydrogel soft-tissue filler.
OBJECTIVE
To evaluate the safety and efficacy of a 2.5% polyacrylamide hydrogel in the aesthetic enhancement of nasolabial folds.


METHODS
The safety and efficacy of a polyacrylamide hydrogel were compared with those of nonanimal stabilized hyaluronic acid (NASHA) in 315 subjects in a double-blind, randomized, multicenter, noninferiority trial with a 12-month follow-up. The primary efficacy end point was mean change in Wrinkle Assessment Scale (WAS) scores at 6 months. The primary safety end point was rate of serious adverse events (AEs) through 12 months after treatment.


RESULTS
Polyacrylamide hydrogel was as effective as NASHA, and effectiveness persisted throughout the 12-month follow-up. Treatment-related AEs occurred with equal incidence; most were mild to moderate, transient, and related to injection procedure. One serious AE (infection) was thought to be related to treatment with polyacrylamide hydrogel; it resolved within 5 days after appropriate treatment.


CONCLUSIONS
This 2.5% polyacrylamide hydrogel offers promise as a long-lasting soft tissue filler. It is well tolerated, as effective as NASHA in correction of nasolabial folds, and persistent. Longer evaluation is required to evaluate longer-term safety and demonstrate duration of effect beyond 12 months. This
Department of Dermatology, School of Medicine, New York University, White Plains, New York 10604, USA. rsnmd1@hotmail.com
Rhoda S
RS
Narins
William P
WP
Coleman
Rodney
R
Rohrich
Gary
G
Monheit
Richard
R
Glogau
Fredric
F
Brandt
Suzanne
S
Bruce
Lawrence
L
Colen
Steven
S
Dayan
Ian
I
Jackson
Corey
C
Maas
Alexander
A
Rivkin
Anthony
A
Sclafani
Joan C
JC
Spivak
D000180:Acrylic Resins / Q000008:administration & dosage*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007267:Injections; D008297:Male; D008875:Middle Aged; D019736:Prostheses and Implants / Q000592:standards*; D015361:Rhytidoplasty / Q000592:standards*; D015595:Skin Aging / Q000187:drug effects*; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
D000180:Acrylic Resins; C016680:polyacrylamide gels