Investigator global evaluations of efficacy of injectable poly-l-lactic acid versus human collagen in the correction of nasolabial fold wrinkles

Fredric S. Brandt, Alex Cazzaniga, Leslie Baumann, Steven Fagien, Scott Glazer, Jeffrey M. Kenkel, Nicholas J. Lowe, Gary D. Monheit, Rhoda S. Narins, Marta I. Rendon, Rod J. Rohrich, William Philip Werschler

Research output: Contribution to journalArticle

8 Citations (Scopus)

Abstract

Background: Injectable poly-L-lactic acid (PLLA) is indicated in the United States for use in immune-competent patients for correction of shallow-to-deep nasolabial fold contour deficiencies and other facial wrinkles in which a deep dermal grid pattern injection technique is appropriate. It is also indicated for restoration and/or correction of signs of lipoatrophy in patients with human immunodeficiency virus.Objective: The authors examine the efficacy of injectable PLLA for correction of nasolabial fold wrinkles, based on Investigator Global Evaluations (IGE).Methods: A randomized, multicenter, subject-blinded, parallel-group study compared injectable PLLA versus human collagen for correction of nasolabial fold wrinkles for 13 months after up to four treatments (intent-to-treat population, 233). Injectable PLLA-treated subjects were followed up for an additional 12 months (total, 25 months) after the final treatment session. Efficacy was also assessed through secondary IGE for improvement, which is the subject of this report.Results: IGE reports of improvement were significantly greater in subjects who received injectable PLLA versus those who received human collagen (p <.001). Overall improvement with injectable PLLA was 100% three weeks after the final treatment, remaining above 85% through month 25. Overall IGE of improvement with human collagen declined from 94.0% at week three to 6.0% at month 13. Both treatment groups had similar safety profiles.Conclusions: IGE of improvement were significantly greater with injectable PLLA treatment than with human collagen treatment at all time points following the last treatment. Injectable PLLA treatment continued to show a beneficial effect for up to 25 months.

Original languageEnglish (US)
Pages (from-to)521-528
Number of pages8
JournalAesthetic Surgery Journal
Volume31
Issue number5
DOIs
StatePublished - Jul 2011

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Nasolabial Fold
Collagen
Research Personnel
Injections
Therapeutics
poly(lactic acid)
HIV

Keywords

  • collagen
  • cosmetic medicine
  • nasolabial folds
  • PLLA
  • poly-L-lactic acid

ASJC Scopus subject areas

  • Surgery

Cite this

Investigator global evaluations of efficacy of injectable poly-l-lactic acid versus human collagen in the correction of nasolabial fold wrinkles. / Brandt, Fredric S.; Cazzaniga, Alex; Baumann, Leslie; Fagien, Steven; Glazer, Scott; Kenkel, Jeffrey M.; Lowe, Nicholas J.; Monheit, Gary D.; Narins, Rhoda S.; Rendon, Marta I.; Rohrich, Rod J.; Werschler, William Philip.

In: Aesthetic Surgery Journal, Vol. 31, No. 5, 07.2011, p. 521-528.

Research output: Contribution to journalArticle

Brandt, FS, Cazzaniga, A, Baumann, L, Fagien, S, Glazer, S, Kenkel, JM, Lowe, NJ, Monheit, GD, Narins, RS, Rendon, MI, Rohrich, RJ & Werschler, WP 2011, 'Investigator global evaluations of efficacy of injectable poly-l-lactic acid versus human collagen in the correction of nasolabial fold wrinkles', Aesthetic Surgery Journal, vol. 31, no. 5, pp. 521-528. https://doi.org/10.1177/1090820X11411161
Brandt, Fredric S. ; Cazzaniga, Alex ; Baumann, Leslie ; Fagien, Steven ; Glazer, Scott ; Kenkel, Jeffrey M. ; Lowe, Nicholas J. ; Monheit, Gary D. ; Narins, Rhoda S. ; Rendon, Marta I. ; Rohrich, Rod J. ; Werschler, William Philip. / Investigator global evaluations of efficacy of injectable poly-l-lactic acid versus human collagen in the correction of nasolabial fold wrinkles. In: Aesthetic Surgery Journal. 2011 ; Vol. 31, No. 5. pp. 521-528.
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abstract = "Background: Injectable poly-L-lactic acid (PLLA) is indicated in the United States for use in immune-competent patients for correction of shallow-to-deep nasolabial fold contour deficiencies and other facial wrinkles in which a deep dermal grid pattern injection technique is appropriate. It is also indicated for restoration and/or correction of signs of lipoatrophy in patients with human immunodeficiency virus.Objective: The authors examine the efficacy of injectable PLLA for correction of nasolabial fold wrinkles, based on Investigator Global Evaluations (IGE).Methods: A randomized, multicenter, subject-blinded, parallel-group study compared injectable PLLA versus human collagen for correction of nasolabial fold wrinkles for 13 months after up to four treatments (intent-to-treat population, 233). Injectable PLLA-treated subjects were followed up for an additional 12 months (total, 25 months) after the final treatment session. Efficacy was also assessed through secondary IGE for improvement, which is the subject of this report.Results: IGE reports of improvement were significantly greater in subjects who received injectable PLLA versus those who received human collagen (p <.001). Overall improvement with injectable PLLA was 100{\%} three weeks after the final treatment, remaining above 85{\%} through month 25. Overall IGE of improvement with human collagen declined from 94.0{\%} at week three to 6.0{\%} at month 13. Both treatment groups had similar safety profiles.Conclusions: IGE of improvement were significantly greater with injectable PLLA treatment than with human collagen treatment at all time points following the last treatment. Injectable PLLA treatment continued to show a beneficial effect for up to 25 months.",
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AU - Brandt, Fredric S.

AU - Cazzaniga, Alex

AU - Baumann, Leslie

AU - Fagien, Steven

AU - Glazer, Scott

AU - Kenkel, Jeffrey M.

AU - Lowe, Nicholas J.

AU - Monheit, Gary D.

AU - Narins, Rhoda S.

AU - Rendon, Marta I.

AU - Rohrich, Rod J.

AU - Werschler, William Philip

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N2 - Background: Injectable poly-L-lactic acid (PLLA) is indicated in the United States for use in immune-competent patients for correction of shallow-to-deep nasolabial fold contour deficiencies and other facial wrinkles in which a deep dermal grid pattern injection technique is appropriate. It is also indicated for restoration and/or correction of signs of lipoatrophy in patients with human immunodeficiency virus.Objective: The authors examine the efficacy of injectable PLLA for correction of nasolabial fold wrinkles, based on Investigator Global Evaluations (IGE).Methods: A randomized, multicenter, subject-blinded, parallel-group study compared injectable PLLA versus human collagen for correction of nasolabial fold wrinkles for 13 months after up to four treatments (intent-to-treat population, 233). Injectable PLLA-treated subjects were followed up for an additional 12 months (total, 25 months) after the final treatment session. Efficacy was also assessed through secondary IGE for improvement, which is the subject of this report.Results: IGE reports of improvement were significantly greater in subjects who received injectable PLLA versus those who received human collagen (p <.001). Overall improvement with injectable PLLA was 100% three weeks after the final treatment, remaining above 85% through month 25. Overall IGE of improvement with human collagen declined from 94.0% at week three to 6.0% at month 13. Both treatment groups had similar safety profiles.Conclusions: IGE of improvement were significantly greater with injectable PLLA treatment than with human collagen treatment at all time points following the last treatment. Injectable PLLA treatment continued to show a beneficial effect for up to 25 months.

AB - Background: Injectable poly-L-lactic acid (PLLA) is indicated in the United States for use in immune-competent patients for correction of shallow-to-deep nasolabial fold contour deficiencies and other facial wrinkles in which a deep dermal grid pattern injection technique is appropriate. It is also indicated for restoration and/or correction of signs of lipoatrophy in patients with human immunodeficiency virus.Objective: The authors examine the efficacy of injectable PLLA for correction of nasolabial fold wrinkles, based on Investigator Global Evaluations (IGE).Methods: A randomized, multicenter, subject-blinded, parallel-group study compared injectable PLLA versus human collagen for correction of nasolabial fold wrinkles for 13 months after up to four treatments (intent-to-treat population, 233). Injectable PLLA-treated subjects were followed up for an additional 12 months (total, 25 months) after the final treatment session. Efficacy was also assessed through secondary IGE for improvement, which is the subject of this report.Results: IGE reports of improvement were significantly greater in subjects who received injectable PLLA versus those who received human collagen (p <.001). Overall improvement with injectable PLLA was 100% three weeks after the final treatment, remaining above 85% through month 25. Overall IGE of improvement with human collagen declined from 94.0% at week three to 6.0% at month 13. Both treatment groups had similar safety profiles.Conclusions: IGE of improvement were significantly greater with injectable PLLA treatment than with human collagen treatment at all time points following the last treatment. Injectable PLLA treatment continued to show a beneficial effect for up to 25 months.

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