Safety of Sculptra®: a review of clinical trial data

• Published in: Journal of cosmetic and laser therapy 2005-12, Vol.7 (3-4), p.201-205
• Main Authors: Engelhard, Peter, Humble, Gail, Mest, Douglas
• Format: Article
• Language: English
• Subjects: Adverse events; Antiretroviral Therapy, Highly Active - adverse effects; Biocompatible Materials - therapeutic use; Clinical Trials as Topic; Cosmetic Techniques; HIV-Associated Lipodystrophy Syndrome - etiology; HIV-Associated Lipodystrophy Syndrome - therapy; Humans; Lactic Acid - therapeutic use; poly-L-lactic acid; Polyesters; Polymers - therapeutic use; safety; side effects
• ISSN: 1476-4172; 1476-4180
• DOI: 10.1080/14764170500451404

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 impermanent, 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.