Long‐term safety and efficacy of poly‐L‐lactic acid in the treatment of HIV‐related facial lipoatrophy

Objective We evaluated the long‐term safety and efficacy of injectable poly‐L‐lactic acid (PLLA) for the correction of facial lipoatrophy. Methods This was a randomized, open‐label, comparative, single‐centre study of injected PLLA in patients with HIV‐related facial lipoatrophy. Thirty subjects wer...

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Bibliographic Details
Published in:HIV medicine 2006-04, Vol.7 (3), p.181-185
Main Authors: Moyle, GJ, Brown, S, Lysakova, L, Barton, SE
Format: Article
Language:English
Subjects:
Adult
Biocompatible Materials - administration & dosage
Biocompatible Materials - adverse effects
Cosmetic Techniques - adverse effects
Drug Implants
Face
Female
Follow-Up Studies
HIV-1
HIV-Associated Lipodystrophy Syndrome - therapy
Human immunodeficiency virus
Humans
Injections
Lactic Acid - administration & dosage
Lactic Acid - adverse effects
lipoatrophy
Male
Pilot Projects
PLLA
Polyesters
Polymers - administration & dosage
Polymers - adverse effects
poly‐L‐lactic acid
Safety
Sculptra™/New‐Fill
Statistics, Nonparametric
Treatment Outcome
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Summary:Objective We evaluated the long‐term safety and efficacy of injectable poly‐L‐lactic acid (PLLA) for the correction of facial lipoatrophy. Methods This was a randomized, open‐label, comparative, single‐centre study of injected PLLA in patients with HIV‐related facial lipoatrophy. Thirty subjects were randomized to immediate or delayed PLLA treatments, administered as three sets of bilateral injections, 2 weeks apart, into the deep dermis above the buccal fat pad. Week 24 results have been published previously (Moyle et al, HIV Medicine 2004, Vol. 5, pp. 82–87). Long‐term efficacy was assessed at a recall visit using visual analogue scales (VASs) to record patient satisfaction, and by the Hospital Anxiety and Depression Scale (HADS). Patients also reported any adverse events (AEs) during the treatment period and at the recall visit. Results Twenty‐seven patients returned for the recall visit, a minimum of 18 months post final study treatment. Fourteen of these patients were excluded from the recall visit because of additional treatment with PLLA. Improvements in VAS scores for facial appearance were sustained from baseline to the recall visit in both randomization groups (P
ISSN:1464-2662
1468-1293
DOI:10.1111/j.1468-1293.2006.00342.x