Background: This study assessed the safety and efficacy of intradermal injections of polylactic acid (PLA) in patients with facial lipoatrophy under antiretroviral therapy.
Methods: In a prospective open-label study, PLA was injected in both cheeks every 2 weeks. The primary efficacy endpoint was the patient's self-perception of improvement as assessed by a visual analogue scale (VAS). Secondary endpoints included 3-dimensional photographs (3DP) to measure dermal thickness, quality of life (QoL) scores, and adverse events.
Results: Ninety-four patients received a median of 5 sets of injection in both cheeks. Median age was 43 years, and median CD4 cell count was 500/mm3. Median VAS score significantly increased from 3.4/10 at baseline to 6.8/10 at the end of the treatment procedure and was sustained at 7/10 at the end of follow-up (P < 0.0001 vs. baseline). Median dermal thickness increase was 2.3 mm at the end of follow-up. QoL scores remained unchanged. Seventeen patients needed further injections of PLA during a median follow-up of 12 months. Injections were well tolerated with only 1 serious adverse event (anaphylactic reaction) that necessitated treatment interruption.
Conclusions: Injections of PLA improved patients' self-perception of facial lipoatrophy, with a good safety profile. The benefit of the procedure, however, decreased with time.
From the *Service des Maladies Infectieuses et Tropicales, †Département de Biostatistique et Informatique Médicales, and ‡Pharmacie Centrale, Hôpital Saint-Louis, Paris, France.
Received for publication June 26, 2004; accepted November 30, 2004.
Supported by a grant from Sidaction, Ensemble contre le Sida (Paris, France). Dermik Laboratories graciously provided polylactic acid for the study.
Presented in part at the 11th Conference on Retroviruses and Opportunistic Infections, San Francisco, CA, February 2004 (abstract 726).
Reprints: Jean-Michel Molina, Service des Maladies Infectieuses et Tropicales, Hôpital Saint-Louis, 1 avenue Claude Vellefaux, 75475 Paris Cedex 10, France (e-mail: email@example.com).