BACKGROUND: Poly-L-lactic acid (PLLA), marketed as Sculptra (Dermik Laboratories, Bridgewater, NJ), is used for subcutaneous volume restoration. Durability studies are ongoing and longevity data are not yet available. OBJECTIVE: We sought to evaluate the long-term efficacy and safety of PLLA during 3 years of follow-up. METHODS: We conducted a prospective cohort study. Primary outcome measures were facial lipoatrophy score, complications, and patient satisfaction. RESULTS: In all, 65 patients were initially treated with PLLA; 27 patients were HIV positive and 38 were HIV negative. Of those patients, 12 were lost to follow-up. Both HIV-positive and HIV-negative patients demonstrated statistically significant improvement in facial lipoatrophy score at the end of 3 years; HIV-positive patients had a net improvement of 2.50 points (P < .01) and HIV-negative patients had a net improvement of 1.11 points (P < .01) on the Facial Lipoatrophy Grading Scale. Subgroup analyses revealed no statistically significant difference in facial lipoatrophy score between years 2 and 3 among patients who did not receive treatment during the third year. Complications were rare and included subcutaneous papule formation, which improved spontaneously and partially responded to subcision in one patient. LIMITATIONS: Sample size was limited in this study. In addition, 12 of 65 patients (18%) were lost to follow-up between years 2 and 3. CONCLUSIONS: PLLA provides volumetric correction of HIV lipoatrophy and lipoatrophy of aging. Results appear to be long lasting and correction can be maintained for up to 3 years with additional treatment sessions. In a subset of patients, correction is maintained for at least 1 year after their last treatment session. Patient satisfaction with PLLA is high.
BACKGROUND:Poly-L-lactic acid (PLLA), marketed as Sculptra (Dermik Laboratories, Bridgewater, NJ), is used for subcutaneous volume restoration. Durability studies are ongoing and longevity data are not yet available. OBJECTIVE: We sought to evaluate the long-term efficacy and safety of PLLA during 3 years of follow-up. METHODS: We conducted a prospective cohort study. Primary outcome measures were facial lipoatrophy score, complications, and patient satisfaction. RESULTS: In all, 65 patients were initially treated with PLLA; 27 patients were HIV positive and 38 were HIV negative. Of those patients, 12 were lost to follow-up. Both HIV-positive and HIV-negative patients demonstrated statistically significant improvement in facial lipoatrophy score at the end of 3 years; HIV-positivepatients had a net improvement of 2.50 points (P < .01) and HIV-negative patients had a net improvement of 1.11 points (P < .01) on the Facial Lipoatrophy Grading Scale. Subgroup analyses revealed no statistically significant difference in facial lipoatrophy score between years 2 and 3 among patients who did not receive treatment during the third year. Complications were rare and included subcutaneous papule formation, which improved spontaneously and partially responded to subcision in one patient. LIMITATIONS: Sample size was limited in this study. In addition, 12 of 65 patients (18%) were lost to follow-up between years 2 and 3. CONCLUSIONS: PLLA provides volumetric correction of HIV lipoatrophy and lipoatrophy of aging. Results appear to be long lasting and correction can be maintained for up to 3 years with additional treatment sessions. In a subset of patients, correction is maintained for at least 1 year after their last treatment session. Patient satisfaction with PLLA is high.
Authors: Ryan M Dickey; Matthew R Louis; Joshua A Cox; Kriti Mohan; Edward I Lee; Marjory G Nigro Journal: Semin Plast Surg Date: 2016-08 Impact factor: 2.314