Consensus Recommendations on the Use of Injectable Poly-L-Lactic Acid for Facial and Nonfacial Volumization

April 2014 | Volume 13 | Issue 4 | Supplement Individual Articles | 44 | Copyright © April 2014


Danny Vleggaar MD,a Rebecca Fitzgerald MD,b Z. Paul Lorenc MD FACS,c J. Todd Andrews MD,d Kimberly Butterwick MD,e Jody Comstock MD,f C. William Hanke MD,g T. Gerald O’Daniel MD FACS,h Melanie D. Palm MD MBA,i Wendy E. Roberts MD,j Neil Sadick MD,k and Craig F. Teller MDl

aHead of Cosmetic Dermatology in Private Practice, Geneva, Switzerland
bDepartment of Medicine, David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, CA, USA
cLorenc Aesthetic Plastic Surgery Center, New York, NY, USA
dRiver Oaks, 3355 West Alabama, Houston, TX, USA
eDermatology/Cosmetic Laser Associates of La Jolla Inc., La Jolla, CA, USA
fSkin Spectrum, Tucson, AZ, USA
gDepartment of Dermatology, Saint Vincent Carmel Medical Center, Laser & Skin Surgery Center of Indiana, Carmel, IN, USA
h222 S. First Street, Louisville, KY, USA
iArt of Skin MD, Solana Beach, CA, USA
j35-280 Bob Hope Drive, Rancho Mirage, CA, USA
kSadick Dermatology, New York, NY, USA
lBellaire Dermatology Associates, 6565 W. Loop S, Bellaire, TX, USA

J. Todd Andrews MD has been a medical consultant for Sinclair IS Pharma, France. He has also been a consultant and trainer for Valeant Pharmaceuticals North America LLC/ Medicis Corporation, and Allergan USA, Inc.
Kimberly J. Butterwick MD has served as an Advisory Board member for Allergan, Inc. and has received honoraria as a consultant for Allergan, Inc., Merz Corporation, and Valeant Pharmaceuticals International, Inc.
Jody A. Comstock, MD has been a physician trainer, speaker, and consultant for Allergan, Inc., Lumenis, and Valeant Pharmaceuticals International, Inc. He has also been a speaker and consultant for Obagi Medical Products, Inc., a division of Valeant Pharmaceuticals North America LLC and SkinCeuticals International.
C. William Hanke MD has served as a consultant for and has received clinical research grants from Valeant Pharmaceuticals International, Inc. to conduct studies on poly-L-lactic acid.
T. Gerald O’Daniel MD FACS serves as a physician trainer for Sculptra for Valeant Pharmaceuticals International, Inc.; he receives no support or financial assistance. He has no other relationships to disclose.
Melanie D. Palm MD MBA has served as a physician trainer, speaker, and consultant for Valeant Pharmaceuticals.
Wendy E. Roberts MD has served as a consultant, speaker, and Advisory Board member for and has received honoraria from: Allergan Medical, Allergan Cosmetic, Kythera Biopharmaceuticals, La Roche-Posay, L'Oréal, MELA Sciences, NeoStrata Company, SkinMedica, Top MD, Theraplex, and Valeant Pharmaceuticals International, Inc.
Neil Sadick MD has received research grants from Allergan, Inc. and Valeant Pharmaceuticals North America LLC, and is a member of the Advisory Board for Merz Pharmaceuticals and Valeant Pharmaceuticals North America LLC.
Craig F. Teller MD has conducted research for Allergan, Inc. and Amgen Inc., and has received consultant honoraria from and served as a member of the Advisory Board and/or Speakers’ Bureau for AbbVie Inc., Allergan, Inc., Amgen Inc., Celgene Corporation, Merz Corporation, Taro Pharmaceuticals U.S.A., Inc., and Valeant Pharmaceuticals International, Inc./Medicis Corporation.

References

  1. Sculptra [package insert]. 2012.
  2. Sculptra Aesthetic [prescribing information]. 2012.
  3. Lowe NJ, Maxwell CA, Lowe P, Shah A, Patnaik R. Injectable poly-L-lactic acid: 3 years of aesthetic experience. Dermatol Surg. 2009;35(suppl 1):s344-s349.
  4. 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(6):923-933.
  5. Moyle GJ, Lysakova L, Brown S, 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(2):82-87.
  6. Valantin MA, Aubron-Olivier C, Ghosn J, 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(17):2471-2477.
  7. Woerle B, Hanke CW, Sattler G. Poly-L-lactic acid: a temporary filler for soft tissue augmentation. J Drugs Dermatol. 2004;3(4):385-389.
  8. 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(3):181-185.
  9. 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(11):1336-1345.
  10. 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(suppl 1):s350-s359.
  11. Burgess CM, Quiroga RM. Assessment of the safety and efficacy of poly-Llactic acid for the treatment of HIV-associated facial lipoatrophy. J Am Acad Dermatol. 2005;52(2):233-239.
  12. Lafaurie M, Dolivo M, Porcher R, Rudant J, Madelaine I, Molina JM. Treatment of facial lipoatrophy with intradermal injections of polylactic acid in HIV-infected patients. J Acquir Immune Defic Syndr. 2005;38(4):393-398.
  13. Guaraldi G, Orlando G, De Fazio D, et al. Comparison of three different interventions for the correction of HIV-associated facial lipoatrophy: a prospective study. Antivir Ther. 2005;10(6):753-759.
  14. 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(6):273-278.
  15. Vleggaar D. Soft-tissue augmentation and the role of poly-L-lactic acid. Plast Reconstr Surg. 2006;118(suppl 3):s46-s54.
  16. Hanke CW, Redbord KP. Safety and efficacy of poly-L-lactic acid in HIV lipoatrophy and lipoatrophy of aging. J Drugs Dermatol. 2007;6(2):123-128.
  17. Engelhard P, Knies M. Safety and efficacy of New-Fill (polylactic acid) in the treatment of HIV-associated lipoatrophy of the face (HALF) [abstract]. Presented at: XIV International AIDS Conference; July 7-12, 2002; Barcelona, Spain.
  18. Engelhard P, Humble G, Mest D. Safety of Sculptra: a review of clinical trial data. J Cosmet Laser Ther. 2005;7(3-4):201-205.
  19. Narins RS, Baumann L, Brandt FS, et al. 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. J Am Acad Dermatol. 2010;62(3):448-462.
  20. Carey D, Baker D, Petoumenos K, et al. Poly-l-lactic acid for HIV-1 facial lipoatrophy: 48-week follow-up. HIV Med. 2009;10(3):163-172.
  21. Carey DL, Baker D, Rogers GD, et al. A randomized, multicenter, open-label study of poly-L-lactic acid for HIV-1 facial lipoatrophy. J Acquir Immune Defic Syndr. 2007;46(5):581-589.
  22. Lee JY, Schulman MR, Skolnik RA. Modified poly-L-lactic acid injection technique: safety and efficacy of “cross-fanning” in non-HIV-related facial atrophy. Ann Plast Surg. 2010;64(4):435-441.
  23. Palm MD, Woodhall KE, Butterwick KJ, Goldman MP. Cosmetic use of poly-l-lactic acid: a retrospective study of 130 patients. Dermatol Surg. 2010;36(2):161-170.
  24. Rossner F, Rossner M, Hartmann V, Erdmann R, Wiest LG, Rzany B. Decrease of reported adverse events to injectable polylactic acid after recommending an increased dilution: 8-year results from the Injectable Filler Safety study. J Cosmet Dermatol. 2009;8(1):14-18.
  25. Survey: Consumers rate soft-tissue treatments tops; choose dermatologic surgeons most often. American Society for Dermatologic Surgery. Available at: http://www.asds.net/_Media.aspx?id=7304. Accessed February 5, 2014.
  26. Mandy SH. Satisfying patient expectations with soft-tissue augmentation. Dermatol Online J. 2009;15(7):1-16.
  27. Weinkle S, Lupo M. Attitudes, awareness, and usage of medical anti-aging treatments: results of a patient survey. J Clin Aesthet Dermatol. 2010;3(9):30-33.
  28. Vleggaar D, Fitzgerald R, Lorenc ZP. Satisfying patient expectations with poly-L-lactic acid soft tissue augmentation. J Drugs Dermatol. 2014;13(suppl 4):s40-s43.
  29. Palm MD, Goldman MP. Patient satisfaction and duration of effect with PLLA: a review of the literature. J Drugs Dermatol. 2009;8(suppl 10):s15-s20.