Journal of the American Academy of Dermatology
Volume 62, Issue 3 , Pages 448-462 , March 2010

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

  • Rhoda S. Narins, MD

      Affiliations

    • Department of Dermatology, New York University School of Medicine, New York, New York
    • Corresponding Author InformationReprint requests: Rhoda S. Narins, MD, Dermatology Surgery and Laser Center, 222 Westchester Ave, White Plains, NY 10604.
  • ,
  • Leslie Baumann, MD

      Affiliations

    • Division of Cosmetic Dermatology, University of Miami, Miami, Florida
  • ,
  • Fredric S. Brandt, MD

      Affiliations

    • private practice, Coral Gables, Florida
  • ,
  • Steven Fagien, MD

      Affiliations

    • private practice, Boca Raton, Florida
  • ,
  • Scott Glazer, MD

      Affiliations

    • private practice, Buffalo Grove, Illinois
  • ,
  • Nicholas J. Lowe, MD, FRCP

      Affiliations

    • Department of Dermatology, University of California-Los Angeles School of Medicine, Los Angeles, California
    • Clinical Research Specialists, Inc, Santa Monica, California
  • ,
  • Gary D. Monheit, MD

      Affiliations

    • Departments of Dermatology and Ophthalmology, University of Alabama at Birmingham, Birmingham, Alabama
  • ,
  • Marta I. Rendon, MD

      Affiliations

    • Dermatology and Aesthetic Center, Inc, Boca Raton, Florida
  • ,
  • Rod J. Rohrich, MD

      Affiliations

    • University of Texas Southwestern Medical Center, Dallas, Texas
  • ,
  • Wm. Philip Werschler, MD

      Affiliations

    • Medicine/Dermatology, University of Washington School of Medicine, Seattle, Washington
    • Premier Clinical Research, Spokane, Washington

References 

  1. American Society of Plastic Surgeons. 2000/2006/2007 National plastic surgery statistics. 2008. Available at: www.plasticsurgery.org/Documents/Media/statistics/2007-full-statistics-report.pdf. Accessed July 15, 2009.
  2. Carruthers A, Carey W, De Lorenzi C, Remington K, Schachter D, Sapra S. Randomized, double-blind comparison of the efficacy of two hyaluronic acid derivatives, Restylane Perlane and Hylaform, in the treatment of nasolabial folds. Dermatol Surg. 2005;31:1591–1598
  3. Narins RS, Bowman PH. Injectable skin fillers. Clin Plast Surg. 2005;32:151–162
  4. Radiesse injectable implant. [package insert] Franksville, WI: BioForm Medical Inc; 2006;
  5. Lupo MP, Smith SR, Thomas JA, Murphy DK, Beddingfield FC. Effectiveness of Juvederm Ultra Plus dermal filler in the treatment of severe nasolabial folds. Plast Reconstr Surg. 2008;121:289–297
  6. Simamora P, Chern W. Poly-L-lactic acid: an overview. J Drugs Dermatol. 2006;5:436–440
  7. Majola A, Vainionpaa S, Vihtonen K, Mero M, Vasenius J, Tormala P, et al. Absorption, biocompatibility, and fixation properties of polylactic acid in bone tissue: an experimental study in rats. Clin Orthop Relat Res. 1991;268:260–269
  8. Gogolewski S, Jovanovic M, Perren SM, Dillon JG, Hughes MK. Tissue response and in vivo degradation of selected polyhydroxyacids: polylactides (PLA), poly(3-hydroxybutyrate) (PHB), and poly(3-hydroxybutyrate-co-3-hydroxyvalerate) (PHB/VA). J Biomed Mater Res. 1993;27:1135–1148
  9. Viljanen JT, Pihlajamaki HK, Tormala PO, Rokkanen PU. Comparison of the tissue response to absorbable self-reinforced polylactide screws and metallic screws in the fixation of cancellous bone osteotomies: an experimental study on the rabbit distal femur. J Orthop Res. 1997;15:398–407
  10. Thissen H, Chang KY, Tebb TA, Tsai WB, Glattauer V, Ramshaw JA, et al. Synthetic biodegradable microparticles for articular cartilage tissue engineering. J Biomed Mater Res A. 2006;77:590–598
  11. Heckmann L, Schlenker HJ, Fiedler J, Brenner R, Dauner M, Bergenthal G, et al. Human mesenchymal progenitor cell responses to a novel textured poly(L-lactide) scaffold for ligament tissue engineering. J Biomed Mater Res B Appl Biomater. 2007;81:82–90
  12. Tunc DC, Jadhav B. Development of absorbable, ultra high strength poly(lactides). In:  Gebelein CG,  Dunn RL editor. Progress in biomedical polymers. New York (NY): Plenum Press; 1990;p. 239–248
  13. Tiitinen A. Hormonal replacement therapy and ovarian cancer. Acta Obstet Gynecol Scand. 2002;81:479–481
  14. Van Patten CL, Olivotto IA, Chambers GK, Gelmon KA, Hislop TG, Templeton E, et al. Effect of soy phytoestrogens on hot flashes in postmenopausal women with breast cancer: a randomized, controlled clinical trial. J Clin Oncol. 2002;20:1449–1455
  15. Valantin MA, Aubron-Olivier C, Ghosn J, Laglenne E, Pauchard M, Schoen H, et al. Polylactic acid implants (New-Fill) to correct facial lipoatrophy in HIV-infected patients: results of the open-label study VEGA. AIDS. 2003;17:2471–2477
  16. Sadick NS, Burgess C. Clinical experience of adverse outcomes associated with poly-L-lactic acid. J Drugs Dermatol. 2007;6:S4–S8
  17. Spenlehauer G, Veillard M, Benoit JP. Formation and characterization of cisplatin loaded poly(d, l-lactide) microspheres for chemoembolization. J Pharm Sci. 1986;75:750–755
  18. Pettit DK, Lawter JR, Huang WJ, Pankey SC, Nightlinger NS, Lynch DH, et al. Characterization of poly(glycolide-co-D, L-lactide)/poly(D, L-lactide) microspheres for controlled release of GM-CSF. Pharm Res. 1997;14:1422–1430
  19. Rokkanen PU. Bioabsorbable polymers for medical applications with an emphasis on orthopedic surgery. In:  Dumitriu S editors. Polymeric biomaterials. 2nd ed. New York (NY): Marcel Dekker; 2002;p. 545–561
  20. Vleggaar D. Facial volumetric correction with injectable poly-L-lactic acid. Dermatol Surg. 2005;31:1511–1517
  21. Werschler WP, Smith SA. Mechanism of action of poly-L-lactic acid: a stimulatory dermal filler. J Drugs Dermatol. 2007;6(1 Suppl):S18–S20
  22. Sculptra(r)Aesthetic [prescribing information]. Bridgewater, NJ: Dermik Laboratories; 2009;
  23. Sculptra [prescribing information]. Bridgewater, NJ: Dermik Laboratories, a business of sanofi-aventis U.S. LLC; 2006;
  24. Cosmoplast [prescribing information]. Santa Barbara, CA: Allergan Inc; 2007;
  25. Baumann L, Kaufman J, Saghari S. Collagen fillers. Dermatol Ther. 2006;19:134–140
  26. Monheit GD, and the Cosmetic Study Trial Group. Photonumeric scoring of nasolabial fold wrinkle correction to compare the efficacy of injectable poly-L-lactic acid and human-derived collagen. Poster presented at: Summer Academy Meeting of the American Academy of Dermatology; August 1-5, 2007; New York, New York.
  27. Woerle B, Hanke CW, Sattler G. Poly-L-lactic acid: a temporary filler for soft tissue augmentation. J Drugs Dermatol. 2004;3:385–389
  28. Lemperle G, Morhenn V, Charrier U. Human histology and persistence of various injectable filler substances for soft tissue augmentation. Aesthetic Plast Surg. 2003;27:354–366
  29. Vleggaar D, Bauer U. Facial enhancement and the European experience with Sculptra (poly-L-lactic acid). J Drugs Dermatol. 2004;3:542–547
  30. Bauer U. Improvement of facial aesthetics at 40 months with injectable poly-L-lactic acid (PLLA). Poster presented at: 17th Congress of the International Society of Aesthetic Plastic Surgery; August 28-31, 2004; Houston, Texas.
  31. Lam SM, Azizzadeh B, Graivier M. Injectable poly-L-lactic acid (Sculptra): technical considerations in soft-tissue contouring. Plast Reconstr Surg. 2006;118:55–63S
  32. Sherman RN. Sculptra: the new three-dimensional filler. Clin Plast Surg. 2006;33:539–550
  33. Hanke CW, Redbord KP. Safety and efficacy of poly-L-lactic acid in HIV lipoatrophy and lipoatrophy of aging. J Drugs Dermatol. 2007;6:123–128
  34. Leonard AL, Hanke CW. A protocol for facial volume restoration with poly-L-lactic acid. J Drugs Dermatol. 2006;5:872–877
  35. Lowe NJ, Maxwell CA, Patnaik R. Adverse reactions to dermal fillers: review. Dermatol Surg. 2005;31:1616–1625
  36. Narins RS, Brandt F, Leyden J, Lorenc ZP, Rubin M, Smith S. A randomized, double-blind, multicenter comparison of the efficacy and tolerability of Restylane versus Zyplast for the correction of nasolabial folds. Dermatol Surg. 2003;29:588–595
  37. Guaraldi G, Orlando G, De Fazio D, De Lorenzi I, Rottino A, De Santis G, et al. Comparison of three different interventions for the correction of HIV-associated facial lipoatrophy: a prospective study. Antivir Ther. 2005;10:753–759
  38. Onesti MG, Renzi LF, Paoletti F, Scuderi N. Use of polylactic acid in face lipodystrophy in HIV positive patients undergoing treatment with antiretroviral drugs (HAART). Acta Chir Plast. 2004;46:12–15
  39. Moyle GJ, Lysakova L, Brown S, Sibtain N, Healy J, Priest C, et al. A randomized open-label study of immediate versus delayed polylactic acid injections for the cosmetic management of facial lipoatrophy in persons with HIV infection. HIV Med. 2004;5:82–87
  40. Moyle GJ, Brown S, Lysakova L, Barton SE. Long-term safety and efficacy of poly-L-lactic acid in the treatment of HIV-related facial lipoatrophy. HIV Med. 2006;7:181–185
  41. Mest DR, Humble G. Safety and efficacy of poly-L-lactic acid injections in persons with HIV-associated lipoatrophy: the US experience. Dermatol Surg. 2006;32:1336–1345
  42. Burgess CM, Quiroga RM. Assessment of the safety and efficacy of poly-L-lactic acid for the treatment of HIV-associated facial lipoatrophy. J Am Acad Dermatol. 2005;52:233–239
  43. Mest DR, Humble GM. Retreatment with injectable poly-L-lactic acid for HIV-associated facial lipoatrophy: 24-month extension of the Blue Pacific study. Dermatol Surg. 2009;35:350–359
  44. Levy RM, Redbord KP, Hanke CW. Treatment of HIV lipoatrophy and lipoatrophy of aging with poly-L-lactic acid: a prospective 3-year follow-up study. J Am Acad Dermatol. 2008;59:923–933
  45. Narins RS, Brandt FS, Lorenc ZP, Maas CS, Monheit GD, Smith SR, et al. A randomized, multicenter study of the safety and efficacy of Dermicol-P35 and non-animal-stabilized hyaluronic acid gel for the correction of nasolabial folds. Dermatol Surg. 2007;33(Suppl):S213–S221
  46. Baumann LS, Shamban AT, Lupo MP, Monheit GD, Thomas JA, Murphy DK, et al. Comparison of smooth-gel hyaluronic acid dermal fillers with cross-linked bovine collagen: a multicenter, double-masked, randomized, within-subject study. Dermatol Surg. 2007;33:S128–S135
  47. Smith S, Busso M, McClaren M, Bass LS. A randomized, bilateral, prospective comparison of calcium hydroxylapatite microspheres versus human-based collagen for the correction of nasolabial folds. Dermatol Surg. 2007;33:S112–S121
  48. Borelli C, Kunte C, Weisenseel P, Thoma-Greber E, Korting HC, Konz B. Deep subcutaneous application of poly-L-lactic acid as a filler for facial lipoatrophy in HIV-infected patients. Skin Pharmacol Physiol. 2005;18:273–278
  49. Vleggaar D. Poly-L-lactic acid: consultation on the injection techniques. J Eur Acad Dermatol Venereol. 2006;20:17–21
  50. Juvéderm Ultra Plus [package insert]. Santa Barbara, CA: Allergan Inc; 2008;
  51. Narins RS, Brandt FS, Lorenc ZP, Maas CS, Monheit GD, Smith SR. Twelve-month persistency of a novel ribose-cross-linked collagen dermal filler. Dermatol Surg. 2008;34(Suppl):S31–S39
  52. Vleggaar D. Soft-tissue augmentation and the role of poly-L-lactic acid. Plast Reconstr Surg. 2006;118:46–54S
  53. Lowe NJ, Maxwell A, Lowe P, Shah A, Patnaik R. Patient satisfaction with injectable poly-L-lactic acid; 3-years' clinical experience. Dermatol Surg. 2009;35(Suppl 1):344–349

 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.

 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.

 Clinical trial registry: NCT00444210 (comparative study); NCT00444353 (long-term follow-up).

PII: S0190-9622(09)00962-1

doi: 10.1016/j.jaad.2009.07.040

Journal of the American Academy of Dermatology
Volume 62, Issue 3 , Pages 448-462 , March 2010