TY - JOUR
T1 - 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
AU - Narins, Rhoda S.
AU - Baumann, Leslie
AU - Brandt, Fredric S.
AU - Fagien, Steven
AU - Glazer, Scott
AU - Lowe, Nicholas J.
AU - Monheit, Gary D.
AU - Rendon, Marta I.
AU - Rohrich, Rod J.
AU - Werschler, Wm Philip
N1 - Funding Information:
Disclosure: Drs Narins, Baumann, Fagien, Glazer, and Monheit were consultants for Dermik Laboratories, a business of sanofi-aventis U.S. LLC, during the time of the study. Dr Brandt receives grant support from Dermik Laboratories , a business of sanofi-aventis U.S. LLC. Dr Lowe was a consultant for and received grant support from Dermik Laboratories , a business of sanofi-aventis U.S. LLC, during the time of the study. Dr Rendon is a consultant for and receives grant support from Dermik Laboratories , a business of sanofi-aventis U.S. LLC. In addition, Dr Rendon is an advisory board member for and receives grant support from BioForm Medical Inc . Dr Werschler was a consultant, investigator, advisory board member, and speaker for Dermik Laboratories, a business of sanofi-aventis U.S. LLC, during the time of the study. Dr Rohrich has no conflicts of interest to declare.
PY - 2010/3
Y1 - 2010/3
N2 - 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. Limitations: Mostly white women and subjects with Fitzpatrick skin types II and III were included. Conclusion: Injectable PLLA provides well-tolerated, effective, and long-lasting (up to 25 months) nasolabial fold wrinkle correction.
AB - 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. Limitations: Mostly white women and subjects with Fitzpatrick skin types II and III were included. Conclusion: Injectable PLLA provides well-tolerated, effective, and long-lasting (up to 25 months) nasolabial fold wrinkle correction.
KW - aesthetic
KW - dermal filler
KW - injectable device
KW - injectable poly-L-lactic acid
KW - soft-tissue augmentation
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U2 - 10.1016/j.jaad.2009.07.040
DO - 10.1016/j.jaad.2009.07.040
M3 - Article
C2 - 20159311
AN - SCOPUS:76249097489
SN - 0190-9622
VL - 62
SP - 448
EP - 462
JO - Journal of the American Academy of Dermatology
JF - Journal of the American Academy of Dermatology
IS - 3
ER -