title: Injectable poly-L-lactic acid for human immunodeficiency virus-associated facial lipoatrophy: cumulative year 2 interim analysis of an open-label study (FACES).
abstract: BACKGROUND
  Studies of injectable poly-L-lactic acid (PLLA) in human immunodeficiency virus (HIV)-associated facial lipoatrophy have predominantly included male Caucasians.
  
  
  OBJECTIVE
  To report cumulative year 2 interim study results examining the safety and efficacy of injectable PLLA in subjects with HIV categorized according to Fitzpatrick skin type and sex.
  
  
  METHODS
  This is an ongoing open-label, multicenter, 5-year study of 290 treated subjects. After correction with injectable PLLA, subjects are being followed annually. Primary end points include incidence and severity of treatment-emergent adverse events (TEAEs). Secondary end points include mean change from baseline of James scale severity grade and treatment satisfaction.
  
  
  RESULTS
  At 2 years, TEAE incidences were: potentially related to study product (n = 53,18.3%) or injection procedure (n = 71, 24.5%), injection-site nodules (n = 24, 8.3%) and papules (n = 25, 8.6%). No hypertrophic scars, keloids, or product-related serious TEAEs were reported. Mean improvement in James scale grade for all groups was 1.4 (p < .001), and 89.4% of subjects and 95.5% of physicians rated treatment satisfaction as very good or excellent.
  
  
  CONCLUSIONS
  At 2 years, injectable PLLA is a safe and effective long-term treatment for HIV-associated facial lipoatrophy regardless of Fitzpatrick skin type; confirmation of these results will be needed at the completion of this 5-year study.
authors: Advanced Facial Plastic Surgery Center, Dallas, Texas, USA.
authors: Benjamin
authors: B
authors: Bassichis
authors: Gary
authors: G
authors: Blick
authors: Marcus
authors: M
authors: Conant
authors: David
authors: D
authors: Condoluci
authors: Michael
authors: M
authors: Echavez
authors: Joseph
authors: J
authors: Eviatar
authors: Michael H
authors: MH
authors: Gold
authors: Tiffani
authors: T
authors: Hamilton
authors: C William
authors: CW
authors: Hanke
authors: Gail
authors: G
authors: Humble
authors: Anthony
authors: A
authors: LaMarca
authors: Elizabeth
authors: E
authors: Daro-Kaftan
authors: Douglas
authors: D
authors: Mest
authors: Gerald
authors: G
authors: Pierone
mesh_terms: D000273:Adipose Tissue / Q000473:pathology*; D000328:Adult; D000368:Aged; D001284:Atrophy; D003357:Cosmetic Techniques; D005260:Female; D015658:HIV Infections / Q000150:complications*; D006801:Humans; D007267:Injections; D019344:Lactic Acid / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D017060:Patient Satisfaction; D011091:Polyesters; D011108:Polymers / Q000008:administration & dosage*
chemical_list: D011091:Polyesters; D011108:Polymers; D019344:Lactic Acid; C033616:poly(lactide)