Improvement in nasolabial folds with a hyaluronic acid filler using a cohesive polydensified matrix technology: results from an 18-month open-label extension trial.
BACKGROUND
Repeat treatments of nonpermanent dermal fillers are used in the long-term treatment of wrinkles and folds and to volumize. OBJECTIVE To determine the safety and effectiveness of a nonanimal-sourced hyaluronic acid (HA) (which uses a cohesive polydensified matrix (CPM) technology [CPMHA]) for the treatment of nasolabial folds (NLFs) during an 18-month open-label extension trial.


METHODS
Ninety-five of 118 subjects continued with this optional open-label extension of a split-face, double-blind trial. All subjects received CPMHA in both NLFs at 24 weeks after treatment in this study and were assessed at weeks 32, 48, 72, and 96. Touch-ups were allowed for optimal correction. Safety was assessed according to reported adverse events (AEs) and serum antibody measurement.


RESULTS
At all four post-week 24 time points, the severity of the NLFs showed a decrease from baseline on the Wrinkle Severity Rating Scale. The effects persisted in the majority (∼80%) of subjects without repeat treatment for at least one interval of 48 weeks. The study filler was well tolerated, with only one related AE (injection site bruising) reported. Little potential for immunogenic reactions was identified.


CONCLUSIONS
This CPMHA is a well-tolerated and effective treatment for at least 48 weeks in the majority of subjects for the correction of moderate to severe NLFs with repeat injections given over an 18-month period.
Narins
Rhoda S
RS
Dermatology Surgery and Laser Center, White Plains, New York 10604, USA. rsnmd@worldnet.att.net
Coleman
William P
WP
Donofrio
Lisa M
LM
Jones
Derek H
DH
Maas
Corey
C
Monheit
Gary
G
Kaur
Mandeep
M
Grundy
Starr L
SL
Pappert
Eric J
EJ
Hardas
Bhushan
B
D000328:Adult; D000368:Aged; D003357:Cosmetic Techniques; D004311:Double-Blind Method; D005145:Face; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage*; D007271:Injections, Intradermal / Q000379:methods; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D015361:Rhytidoplasty / Q000379:methods*; D015595:Skin Aging; D013997:Time Factors; D016896:Treatment Outcome; D055675:Viscosupplements / Q000008:administration & dosage*
D055675:Viscosupplements; D006820:Hyaluronic Acid