Correction Of Facial Lipoatrophy Research Articles

Evaluation of Injectable Calcium Hydroxylapatite for the Treatment of Facial Lipoatrophy Associated with Human Immunodeficiency Virus

To evaluate the safety and effectiveness of soft tissue augmentation with calcium hydroxylapatite (CaHA) microspheres in an aqueous gel in patients with facial lipoatrophy (FLA) secondary to human immunodeficiency virus (HIV) disease. This 12-month open-label, prospective study enrolled 30 subjects (29 men and 1 woman) with HIV-associated FLA. After the initial treatment phase (up to 2 injections, 30 days apart), patients were followed up at 3, 6, and 12 months. Patients were offered touch-up injections at 6 and 12 months. Measurements included confirmed changes in the Global Aesthetic Improvement Scale and in cheek thickness. Average initial treatment volume was 9.5 mL per patient (both sides); total volumes per patient after 12 months averaged 16.1 mL. At all time points, all patients were rated as improved or better and responded affirmatively to satisfaction questions. Cheek thickness measurements increased substantially over baseline (p<.001). Most commonly reported adverse events were edema (93%), ecchymosis (83%), and erythema (77%). CaHA is an appropriate and well-tolerated treatment for patients with HIV-associated FLA. With an excellent safety profile, CaHA provides immediate correction of FLA and appears to provide lasting improvement in appearance.

Duration of Correction for Human Immunodeficiency Virus-Associated Lipoatrophy After Retreatment with Injectable Poly-l-Lactic Acid

The Blue Pacific study assessed the effect of injectable poly-L-lactic acid (PLLA) (Sculptra; Dermik Laboratories, a business of Sanofi-Aventis U.S. LLC, Bridgewater, NJ, USA) for the treatment of human immunodeficiency virus (HIV)-associated facial lipoatrophy. This case report describes a patient treated originally with injectable PLLA in the Blue Pacific study, then retreated with injectable PLLA 12 months after completion of his initial treatment sessions. Retreatment was well tolerated and resulted in a correction of facial lipoatrophy for a duration of 2 years 7 months.

Prospective, Open-Label, 18-Month Trial of Calcium Hydroxylapatite (Radiesse) for Facial Soft-Tissue Augmentation in Patients with Human Immunodeficiency Virus-Associated Lipoatrophy: One-Year Durability

The objective was to evaluate the safety and effectiveness of soft-tissue augmentation of calcium hydroxylapatite (Radiesse) in patients with facial lipoatrophy secondary to human immunodeficiency virus disease. This 18-month, prospective, open-label, multicenter clinical trial of calcium hydroxylapatite for soft-tissue augmentation of patients with facial lipoatrophy enrolled 100 subjects (94 men and six women). Correction of facial lipoatrophy was evaluated by comparing changes from baseline using the Global Aesthetic Improvement Scale, with confirmation using standardized photography. All 100 patients were determined to be improved or better at 3 months. Secondary effectiveness endpoints-improvement at 6 months on the scale and skin thickness measurements at 3 and 6 months-were also met. Twelve-month data and 18-month scale scores were also available. One hundred percent of assessable patients were rated as improved or better on the scale at every time point through 12 months; 91 percent were improved or better at 18 months. "Yes" responses to all patient satisfaction questions ranged from 97 percent to 100 percent at every evaluation through 12 months. In addition, skin thickness measurements at 12 months remained statistically better than those at baseline. Eighteen-month patient satisfaction and skin thickness measurements were not available at the time of submission. Adverse events reported through 12 months were generally mild (ecchymosis, edema, erythema, pain, and pruritus), not unexpected, and generally short in duration. Eighteen-month safety data were not available at the time of submission. Radiesse is an appropriate and well-tolerated treatment for patients with facial lipoatrophy. It demonstrates an excellent safety profile, causes immediate augmentation of the soft tissues, and appears to provide relatively long-lasting improvement in appearance, with very high patient satisfaction.

Poly-L-lactic Acid for Facial Lipoatrophy in HIV

To review the clinical data for poly-L-lactic acid, a synthetic polymer used as an intradermal injection for the treatment of HIV associated facial fat loss (lipoatrophy). A literature search was performed using MEDLINE (1966-August 2006). The search was limited to articles published in English and used the key words polylactic acid, polylactides, degradation, lipodystrophy, lipoatrophy, and HIV/AIDS. Dermik Laboratories was contacted to obtain unpublished information. Additional articles were retrieved from citations of selected references. Relevant information on the pharmacology, pharmacokinetics, safety, and efficacy of poly-L-lactic acid from clinical trials were selected. Poly-L-lactic acid (Sculptra) is a biocompatible, biodegradable, synthetic polymer able to be tailored into various desired morphologic features. It is approved by the Food and Drug Administration for the correction of facial lipoatrophy in people with HIV. Six clinical trials have evaluated the use of intradermal injections of poly-L-lactic acid. Results showed that cutaneous thickness is improved in patients receiving poly-L-lactic acid. Adverse effects included nodule and hematoma formation, as well as pain at the injection site. Poly-L-lactic acid offers a treatment alternative for patients with HIV-associated lipoatrophy. Further research is required in nonwhite populations.