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J Am Acad Dermatol. 2010 Mar;62(3):448-62. doi: 10.1016/j.jaad.2009.07.040.

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.

Author information

1
Department of Dermatology, New York University School of Medicine, New York, New York, USA.

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.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00444210 NCT00444353.

PMID:
20159311
DOI:
10.1016/j.jaad.2009.07.040
[Indexed for MEDLINE]

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