Injectable poly-L-lactic acid for human immunodeficiency virus-associated facial lipoatrophy: cumulative year 2 interim analysis of an open-label study (FACES).

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. MATERIALS AND 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. CONCLUSION: 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.

Review and Evaluation of Treatment Procedures Using Injectable Poly-L-Lactic Acid in the Treatment of Human Immunodeficiency Virus-associated Facial Lipoatrophy.

Injectable poly-L-lactic acid is United States Food and Drug Administration-approved for the restoration and/or correction of the signs of lipoatrophy in people with human immunodeficiency virus and for use in immune-competent people for the correction of nasolabial fold contour deficiencies. Current prescribing information recommends using either a tunneling or threading technique in a grid or cross-hatched pattern or a depot technique (in thin skin areas) to administer multiple passes of injectable poly-L-lactic acid per treatment session via a 26-gauge needle. A review of the literature and the recently published guidelines from the American Society for Dermatologic Surgery provide evidence to support the use of a cross-fanning technique with a 25-gauge needle. In conclusion, the use of a cross-fanning injection technique with a 25-gauge needle to administer injectable poly-L-lactic acid provides a clinically valid, alternate delivery option for the treatment of patients with human immunodeficiency virus-associated lipoatrophy.

Retreatment with injectable poly-l-lactic acid for HIV-associated facial lipoatrophy: 24-month extension of the Blue Pacific study.

BACKGROUND: Facial lipoatrophy occurs in HIV-positive patients taking highly active antiretroviral therapy and during natural aging. Injectable poly-l-lactic acid (PLLA) is a device approved internationally for restoration and correction of the signs of HIV-associated facial lipoatrophy. OBJECTIVE: To evaluate the long-term safety, duration of effect, and satisfaction with serial injections of PLLA for HIV-associated facial lipoatrophy. METHODS AND MATERIALS: In this single-site, open-label, retreatment study, 65 HIV-positive patients were treated with injectable PLLA every 5 weeks (until optimal recorrection). Presenting degree of lipoatrophy based on the James scale (1=mild, 4=severe) was reviewed. Skin thickness was measured at fixed points with calipers. Patients completed a post-retreatment satisfaction questionnaire. RESULTS: Nearly 10% of patients had persistent correction >36 months, based on patient report. Approximately 50% required three or fewer retreatments to maintain satisfactory correction (determined by patient and physician). Milder lipoatrophy on initial presentation required fewer retreatments and had more sustained correction. Time to first retreatment varied according to James scale score: 1 (21.4 months) and 4 (13.0 months). The mean patient satisfaction score was 4.9 (1=dissatisfied, 5=very satisfied) at study end. No serious adverse events were reported. CONCLUSION: Injectable PLLA is a safe and effective long-term treatment option for HIV-associated lipoatrophy.

Safety and efficacy of poly-L-lactic acid injections in persons with HIV-associated lipoatrophy: the US experience.

BACKGROUND: With the introduction of highly active antiretroviral therapy (HAART), HIV/AIDS has become a more chronic disease. This increase in survival, however, has been accompanied by the occurrence of metabolic and morphologic changes known collectively as HIV-associated lipodystrophy. OBJECTIVE: The objective was to evaluate the quantifiable improvement in facial wasting (lipoatrophy) after serial injections of poly-L-lactic acid (PLLA) as well as the long-term safety and durability of this material. METHODS AND MATERIALS: A single-site, open-label study in which patients received up to six treatment sessions of injectable PLLA. Patients were followed for 12 months after treatment. Patients were evaluated for increase in total cutaneous thickness by skin calipers. Serial photographs and patient satisfaction and patient well-being questionnaires were undertaken throughout the study period. RESULTS: Patients at the end of treatment exhibited a mean increase in skin thickness of 65.1% compared with baseline values. This correction was maintained throughout the 12-month follow-up period (68.8% at 6 months and 73% at 12 months). On a one to five scale, patient satisfaction was 4.5 at the end of treatment and increased to 4.8 at 12-month follow-up. No serious adverse events were reported. CONCLUSION: PLLA is a safe and well-tolerated treatment option for HIV-associated lipoatrophy.

Safety of Sculptra: a review of clinical trial data.

The development of facial lipoatrophy as a result of highly active antiretroviral therapy (HAART) used to treat patients with human immunodeficiency virus (HIV) has adversely affected patient quality of life and compliance with therapy. Thanks to modern pharmacotherapies, HIV can now be viewed as a chronic disease; however, this welcome change has exacerbated the effect of facial lipoatrophy since HIV-infected patients can now expect to live longer and healthier lives but remain subject to public scrutiny of their ongoing disease state. Sculptra (Dermik Laboratories, Berwyn, PA, USA) has recently been introduced in the USA for correction of the appearance of facial lipoatrophy. The device affords long-lasting restoration while still being non-permanent, thus providing an extended but adjustable cosmetic effect. The safety profile of this product has been observed in four investigator-initiated clinical trials of more than 250 HIV patients and in numerous investigator reports, with no serious adverse events or infections deemed associated with the product. Maintenance of the excellent safety profile for this injectable device requires adherence to a novel technique and appreciation of its unique attributes.

Soft tissue augmentation using sculptra.

Sculptra (poly-L-lactic acid) as of August 2004 has been approved by the U.S. Food and Drug Administration as the first injectable facial volumizer in the treatment of lipoatrophy. Lipoatrophy is often seen in HIV-positive patients and is felt to be multifactorial. This article reviews European and U.S. clinical study data and summarize treatment technique for both on label and off-label use.

Soft tissue augmentation using silicone: an historical review.

Silicone has a long and colorful history in cosmetic medicine. We are once again seeing a resurgence of its use as a soft tissue filler. This article is a review of the historical past of silicone use and its appropriate off-label uses today in cosmetic medicine.