A randomized study of the efficacy and safety of injectable poly-L-lactic acid versus human-based collagen implant in the treatment of nasolabial fold wrinkles.
BACKGROUND
Injectable poly-L-lactic acid (PLLA) is a synthetic, biodegradable, biocompatible polymer device.


OBJECTIVE
We sought to compare the efficacy and safety of injectable PLLA with human-derived collagen in treating nasolabial fold wrinkles.


METHODS
In this randomized, evaluator-blinded, parallel-group, multicenter study, subjects received injectable PLLA (n = 116) or collagen (n = 117) injections (1-4 visits, 3-week intervals). Wrinkle Assessment Scale scores were calculated at screening; posttreatment week 3; months 3, 6, 9, and 13 (injectable PLLA or collagen groups); and months 19 and 25 (injectable PLLA group). Safety data were obtained from subject interviews and case report forms.


RESULTS
Injectable PLLA significantly improved mean Wrinkle Assessment Scale scores (all time points, P < .001). Improvements (up to 25 months after last treatment) were significantly greater (P < .001) than with collagen for posttreatment months 3 to 13.


CONCLUSIONS
Mostly white women and subjects with Fitzpatrick skin types II and III were included.


CONCLUSIONS
Injectable PLLA provides well-tolerated, effective, and long-lasting (up to 25 months) nasolabial fold wrinkle correction.
Narins
Rhoda S
RS
Department of Dermatology, New York University School of Medicine, New York, New York, USA.
Baumann
Leslie
L
Brandt
Fredric S
FS
Fagien
Steven
S
Glazer
Scott
S
Lowe
Nicholas J
NJ
Monheit
Gary D
GD
Rendon
Marta I
MI
Rohrich
Rod J
RJ
Werschler
Wm Philip
WP
D003094:Collagen / Q000009:adverse effects / Q000627:therapeutic use*; D003357:Cosmetic Techniques; D005260:Female; D006801:Humans; D007271:Injections, Intradermal / Q000379:methods; D019344:Lactic Acid / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011091:Polyesters; D011108:Polymers / Q000009:adverse effects / Q000627:therapeutic use*; D015595:Skin Aging
D011091:Polyesters; D011108:Polymers; D019344:Lactic Acid; C033616:poly(lactide); D003094:Collagen