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.
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.
Authors: Phyllis C Tien; Yolanda Barrón; Jessica E Justman; Charles Hyman; Mardge H Cohen; Mary Young; Andrea Kovacs; Stephen R Cole Journal: AIDS Patient Care STDS Date: 2007-05 Impact factor: 5.078