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 - 24/04/13
Abstract |
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.
Le texte complet de cet article est disponible en PDF.Key words : aesthetic, dermal filler, injectable device, injectable poly-L-lactic acid, soft-tissue augmentation
Abbreviations used : AE, CRF, NLFW, PLLA, WAS
Plan
Sponsored by Dermik Laboratories, a business of sanofi-aventis U.S. LLC. Editorial support for this article was also provided by Dermik Laboratories, a business of sanofi-aventis U.S. LLC, and by the editorial staff at Medicus International and Embryon. |
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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. |
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Clinical trial registry: NCT00444210 (comparative study); NCT00444353 (long-term follow-up). |
Vol 62 - N° 3
P. 448-462 - mars 2010 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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