Burgess CM, Quiroga RM.. Assessment of the safety and efficacy of poly-L-lactic acid for the treatment of HIV-associated facial lipoatrophy

Center for Dermatology and Dermatologic Surgery, Washington, DC 20037, USA.
Journal of the American Academy of Dermatology (Impact Factor: 4.45). 03/2005; 52(2):233-9. DOI: 10.1016/j.jaad.2004.08.056
Source: PubMed


Lipodystrophy syndrome is uniquely associated with the use of highly active antiretroviral therapy (HAART) containing protease inhibitors or nucleoside reverse transcriptase inhibitors. Between 15% and 80% of patients on HAART develop facial lipoatrophy within 10 months of initiating therapy. At present, no ideal treatment strategies have emerged in spite of the psychosocial stress, resulting in depression and isolation in many HIV-infected patients. Most soft tissue fillers seem to be well tolerated; however, various reactions such as allergic reactions, infection, and inflammatory and allergic granulomatous nodules are possible. Poly-L-lactic acid (PLA; New-Fill, Biotech Industry SA, Luxembourg) is currently being used in Europe and is approved by the Food and Drug Administration (FDA) in the United States for soft tissue augmentation in HIV-associated facial lipoatrophy.
To determine the safety and efficacy of PLA for dermal enhancement of facial lipoatrophy in immuncompromised HIV-infected patients with prior use of HAART.
Sixty-one immunocompromised, HIV-infected male patients (52 whites, 7 African Americans, 1 Latino, and 1 Asian) underwent multiple treatment sessions with PLA over a 5-month period for facial lipoatrophy. The severity of facial lipoatrophy was assessed and photographs were taken at baseline and before each treatment session. Periodic monitoring for adverse reactions and degree of improvement were assessed by the patient, the treating physician, and a non-treating physician.
At the 6-month follow-up, all 61 immunocompromised HIV patients had a successful outcome, defined as smoothing of the skin with less concavities or depressions, and improved overall appearance in an average of 3 treatment sessions. Although all patients were very pleased with their results, two patients developed persistent asymptomatic palpable intradermal papules in the infraorbital region as a result of the site of placement and concentration of PLA. On long-term follow-up (18 months), 48 of 61 (79%) required an average of 3 visits to achieve the desired enhancement and 13 of 61 (21%) patients requested additional treatment sessions beyond the initial 3 sessions. Although the patient and the physicians rated the level of improvement as "Excellent," the desire for further dermal enhancement was purely subjective. In general, the procedures were well tolerated without the clinical development of adverse reactions.
The use of PLA to treat facial lipoatrophy resulted in significant and prolonged improvement in HIV-infected patients. The effect was long lasting, for up to 2 years in some patients, depending on when treatment was initiated. There were no reported cases of infection, allergies, or serious adverse reactions, and the treatment was well tolerated.

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    • "Injectable Poly-L-lactic acid (PLLA) was introduced into Europe in 1999 as New-fill ® , receiving European Union approval to increase the volume of depressed areas, such as skin creases, wrinkles, folds and scars. In February of 2004, this indication was extended to include largevolume corrections of lipoatrophy, and in the same year it received U.S. Food and Drug Administration approval for the restoration and/or correction of the signs of facial lipoatrophy in people with human immunodeficiency virus [1]. Its cosmetic use was approved by the FDA in 2009 [2] and relies upon volumetric expansions as well as the formation of new collagen and elastic fibers. "
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    ABSTRACT: Background: Wrinkles are characterized by changes in the organization and structure of the dermis. Human wrinkle fibroblasts (WF) have a different functional behaviour in comparison with normal-aged fibroblasts (NF). Decreases in migration capacities and collagen I synthesis are observed. Mitochondrial function is impaired with an increase in lac-tate production during aging. Sculptra® (poly-L-lactic acid: PLLA), a biodegradable synthetic polymer, is used for sub-cutaneous volume restoration. Thus we decided to investigate different fibroblast functions when placed in contact with PLLA. Objectives: The potential of PLLA to compensate for the reduction of metabolic activity, to restore the migra-tion capacity of WF and to inhibit the lactate production, was investigated and compared to NF. Methods: Two differ-ent skin samples were used from each of the three women’s facelift (one inside a face wrinkle and one from normal aged skin). Collagen I, lactate productions and proliferation capacities were investigated on monolayer cultures. Migra-tion properties were evaluated using three-dimensional collagen lattices. Results: PLLA increased collagen I synthesis, restored migration capacities and tended to decrease lactate production in WF, whereas PPLA stimulated proliferation in NF and tended to improve the migration of NF. Conclusion: These results suggested that PLLA from Sculptra® acted as a stimulus for collagen production in WF and that it is suitable for correcting skin depressions, such as wrinkles.
    Full-text · Article · Jan 2012 · Journal of Cosmetics, Dermatological Sciences and Applications
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    • "For example, Burgess and Quiroga (2005) used PLA to treat lipoatrophy in 61 HIV-infected patients over a 5-month period. The amount of PLA varied from 1–4 vials, depending on the degree of lipoatrophy severity and areas of involvement. "
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    ABSTRACT: In the quest for the "ideal" soft tissue filler, many diverse products have been developed. The expanding market of available fillers is a testament that no one product will ideally suit all patients or clinicians. In addition, the challenge of satisfying the criteria of an ideal filler has driven researchers to take a variety of development paths. This has resulted in multiple categories to characterize soft tissue fillers. These fillers are categorized according to: (1) filler material, eg, autologous, natural, synthetic; (2) mechanism of action, eg, void filler, neocollagenesis, fibroblast stimulation; (3) patient type and profile, eg, younger versus older patient, rhytids versus "sinking and sagging" skin; or (4) durability of treatment effects, eg, temporary, semi-permanent, or permanent. Although strategies for soft tissue augmentation may be quite diverse, strategies should share a universal goal to address fat redistribution (atrophy and hypertrophy), the primary underlying morphological cause of facial aging. To accomplish this, volumizers are now available that are injected more deeply, resulting in the restoration of supportive structure and foundation. These can be used in combination with other products that are used more superficially for smoothing skin surfaces. As numerous soft tissue fillers enter the market, mechanisms and injection techniques become more divergent, and therefore require that the dermatologist and cosmetic surgeon receive adequate training to use products safely and effectively. This manuscript provides an overview of soft tissue fillers and their proper use.
    Preview · Article · Feb 2006 · Clinical Interventions in Aging
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    ABSTRACT: Background Facial hemiatrophy, a typical manifestation of Parry-Romberg syndrome, produces massive face asymmetry, causing marked aesthetic damage and severe psychological discomfort, with repercussions to the psychophysical status of the patient. This article presents a successful combined treatment that results in resolution of symptoms and patient satisfaction. Methods The authors proposed a clinic-therapeutic management comprising a customized program of bio-lipo-intense pulsed light (IPL) remodeling. Results In 2007, at a 1-year follow-up visit, the patient presented a stable result. She is satisfied with the augmentation treatment, the new volume and contours of the face, and the resolution of the sclerosis and ochrodermia. Conclusion The authors have succeeded with a minimally invasive reconstructive technique for Romberg disease using a customized therapeutic program of poly-L-lactic acid, lipofilling, and IPL therapy. They report a case of good healing without recurrences and complications, with a good cosmetic result, and with satisfaction of the patient.
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