PMID- 20969659
OWN - NLM
STAT- MEDLINE
DCOM- 20101130
LR  - 20101025
IS  - 1524-4725 (Electronic)
IS  - 1076-0512 (Linking)
VI  - 36 Suppl 3
DP  - 2010 Nov
TI  - 12-Month controlled study in the United States of the safety and efficacy of a 
      permanent 2.5% polyacrylamide hydrogel soft-tissue filler.
PG  - 1819-29
LID - 10.1111/j.1524-4725.2010.01736.x [doi]
AB  - OBJECTIVE: To evaluate the safety and efficacy of a 2.5% polyacrylamide hydrogel 
      in the aesthetic enhancement of nasolabial folds. METHODS AND MATERIALS: 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. CONCLUSION: 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
CI  - (c) 2010 by the American Society for Dermatologic Surgery, Inc.
FAU - Narins, Rhoda S
AU  - Narins RS
AD  - Department of Dermatology, School of Medicine, New York University, White Plains, 
      New York 10604, USA. rsnmd1@hotmail.com
FAU - Coleman, William P 3rd
AU  - Coleman WP 3rd
FAU - Rohrich, Rodney
AU  - Rohrich R
FAU - Monheit, Gary
AU  - Monheit G
FAU - Glogau, Richard
AU  - Glogau R
FAU - Brandt, Fredric
AU  - Brandt F
FAU - Bruce, Suzanne
AU  - Bruce S
FAU - Colen, Lawrence
AU  - Colen L
FAU - Dayan, Steven
AU  - Dayan S
FAU - Jackson, Ian
AU  - Jackson I
FAU - Maas, Corey
AU  - Maas C
FAU - Rivkin, Alexander
AU  - Rivkin A
FAU - Sclafani, Anthony
AU  - Sclafani A
FAU - Spivak, Joan C
AU  - Spivak JC
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - Dermatol Surg
JT  - Dermatologic surgery : official publication for American Society for Dermatologic 
      Surgery [et al.]
JID - 9504371
RN  - 0 (Acrylic Resins)
RN  - 0 (polyacrylamide gels)
SB  - IM
MH  - Acrylic Resins/*administration & dosage
MH  - Double-Blind Method
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Injections
MH  - Male
MH  - Middle Aged
MH  - Prostheses and Implants/*standards
MH  - Rhytidoplasty/*standards
MH  - Skin Aging/*drug effects
MH  - Time Factors
MH  - Treatment Outcome
MH  - United States
EDAT- 2010/11/05 06:00
MHDA- 2010/12/14 06:00
CRDT- 2010/10/26 06:00
PHST- 2010/10/26 06:00 [entrez]
PHST- 2010/11/05 06:00 [pubmed]
PHST- 2010/12/14 06:00 [medline]
AID - 10.1111/j.1524-4725.2010.01736.x [doi]
PST - ppublish
SO  - Dermatol Surg. 2010 Nov;36 Suppl 3:1819-29. doi: 
      10.1111/j.1524-4725.2010.01736.x.