Safety of Sculptra®: A review of clinical trial data

Journal of Cosmetic and Laser Therapy

Volumn 7, Issue 3-4, 2005, Pages 201-205

  Engelhard, Peter ^a   Humble, Gail ^b   Mest, Douglas ^b  

^a Apex South Beach   (United States)

^b Blue Pacific Aesthetic Medical Group   (United States)

Author keywords

Adverse events; Poly L lactic acid; Safety; Side effects

Indexed keywords

POLYLACTIC ACID; BIOMATERIAL; LACTIC ACID; POLYMER;

CLINICAL TRIAL; CONFERENCE PAPER; DISEASE EXACERBATION; HUMAN; INJECTION SITE CONTUSION; INJECTION SITE DISCOMFORT; INJECTION SITE EDEMA; INJECTION SITE ERYTHEMA; INJECTION SITE INFLAMMATION; INJECTION SITE IRRITATION; LIPOATROPHY; MAINTENANCE THERAPY; PRIORITY JOURNAL; ESTHETIC SURGERY; HIGHLY ACTIVE ANTIRETROVIRAL THERAPY; HIV ASSOCIATED LIPODYSTROPHY; REVIEW;

ANTIRETROVIRAL THERAPY, HIGHLY ACTIVE; BIOCOMPATIBLE MATERIALS; CLINICAL TRIALS; COSMETIC TECHNIQUES; HIV-ASSOCIATED LIPODYSTROPHY SYNDROME; HUMANS; LACTIC ACID; POLYMERS;

EID: 30944458800     PISSN: 1462883X     EISSN: 14764180     Source Type: Journal    
DOI: 10.1080/14764170500451404     Document Type: Conference Paper

References (24)

1. Kulkarni RK, Pani KC, Neuman C, Leonard F. Polylactic acid for surgical implants. Arch Surg. 1966;93:839-43.
2. Kulkarni RK, Moore EG, Hegyeli AF, Leonard F. Biodegradable poly(lactic acid) polymers. J Biomed Mater Res. 1971;5:169-81.
3. Kronenthal RL. Biodegradable polymers in medicine. In: Kronenthal RL, Oser Z, Martin E, editors. Polymer science and technology. New York: Plenum Press, 1975. p. 119-37.
4. Nakamura S, Ninomiya S, Takatori Y, Morimoto S, Kusaba I, Kurokawa T. Polylactide screws in acetabular osteotomy. 28 dysplastic hips followed for 1 year. Acta Orthop Scand. 1993;64:301-2.
5. 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;14:1422-30.
6. Spenlehauer G, Veillard M, Benoit JP. Formation and characterization of cisplatin loaded poly(d,1-lactide) microspheres for chemoembolization. J Pharm Sci. 1986;75:750-5.
7. Vleggaar D, Bauer U. Facial enhancement and the European experience with poly-L-lactic acid. J Drugs Dermatol. 2004;3:542-7.
8. Woerle B, Hanke CW, Sattler G. Poly-L-lactic acid: a temporary filler for soft tissue augmentation. J Drugs Dermatol. 2004;3:385-9.
9. Bauer U. Correction of facial deformities with poly-L-lactic acid: 40-month follow-up. J Eur Acad Dermatol Venereol. 2004;18(s2):193-557.
10. Champe PC, Harvey RA. Lippincott's illustrated reviews: biochemistry. 2nd ed. Philadelphia: Lippincott Williams & Wilkins, 1994.
11. Lodish H, Berk A, Zipursky SL. Cellular energetics: glycolysis, aerobic oxidation, and photosynthesis. In: Molecular cell biology. New York: WH Freeman and Company, 2000. p. 622-6.
12. 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;27:1135-48.
13. Bos RR, Rozema FR, Boering G, Nijenhuis AJ, Pennings AJ, Verwey AB, et al. Degradation of and tissue reaction to biodegradable poly(L-lactide) for use as internal fixation of fractures: a study in rats. Biomaterials. 1991;12:32-6.
14. Brady JM, Cutright DE, Miller RA, Barristone GC. Resorption rate, route, route of elimination, and ultrastructure of the implant site of polylactic acid in the abdominal wall of the rat. J Biomed Mater Res. 1973;7:155-66.
15. Cutright DE, Perez B, Beasley JD 3rd, Larson WJ, Posey WR. Degradation rates of polymers and copolymers of polylactic and polyglycolic acids. Oral Surg Oral Med Oral Pathol. 1974;37:142-52.
16. Sattler G. Long-lasting results with polylactic acid. Dermatology. 2003;9:422-3.
17. Sommer B. Crystalline polylactic acid (New-Fill): current handling guidelines. Skin. 2004;15:1-4.
18. Wolters M, Lampe H. Experiences with New-Fill for the treatment of wrinkles and contour defects in the face. P 74 ISAPS 2003. Houston TX.
19. 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.
20. 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;17:2471-7.
21. 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;5:82-7.
22. Carr A, Emery S, Law M, Puls R, Lundgren JD, Powderly WG. An objective case definition of lipodystrophy in HIV-infected adults: a case-control study. Lancet. 2003;361:726-35.
23. Engelhard P, Knies M. Safety and efficacy of New-Fill® (polylactic acid) in the treatment of HIV-associated lipoatrophy of the face (HALF). In: XIV International AIDS Conference 2002. Barcelona: Monduzzi Editore, 2002.
24. Mest DR, Humble G. Safety and efficacy of intradermal poly-L-lactic acid (Sculptra) injections in patients with HIV-associated facial lipoatrophy. Antiviral Ther. 2004;9:L36.