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 wit...

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Published in	Dermatologic surgery Vol. 38; no. 7pt2; pp. 1193 - 1205
Main Authors	Bassichis, Benjamin, Blick, Gary, Conant, Marcus, Condoluci, David, Echavez, Michael, Eviatar, Joseph, Gold, Michael H., Hamilton, Tiffani, Hanke, C. William, Humble, Gail, LaMarca, Anthony, Daro‐Kaftan, Elizabeth, Mest, Douglas, Pierone, Gerald
Format	Journal Article
Language	English
Published	United States 01.07.2012
Subjects	Adipose Tissue - pathology Adult Aged Atrophy Cosmetic Techniques Female HIV Infections - complications Human immunodeficiency virus Humans Immunodeficiency Injections Lactic Acid - administration & dosage lipoatrophy Male Middle Aged Nodules Patient Satisfaction Polyesters Polylactic acid Polymers - administration & dosage Sex Skin Tea Tetraethylammonium
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Abstract	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.
AbstractList	Studies of injectable poly-L-lactic acid (PLLA) in human immunodeficiency virus (HIV)-associated facial lipoatrophy have predominantly included male Caucasians.BACKGROUNDStudies of injectable poly-L-lactic acid (PLLA) in human immunodeficiency virus (HIV)-associated facial lipoatrophy have predominantly included male Caucasians.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.OBJECTIVETo 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.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.MATERIALS AND METHODSThis 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.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.RESULTSAt 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.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.CONCLUSIONAt 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. Studies of injectable poly-L-lactic acid (PLLA) in human immunodeficiency virus (HIV)-associated facial lipoatrophy have predominantly included male Caucasians. 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. 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. 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. 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. 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. Studies of injectable poly-l-lactic acid (PLLA) in human immunodeficiency virus (HIV)-associated facial lipoatrophy have predominantly included male Caucasians. 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. 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. 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. 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.
Author	Hanke, C. William Conant, Marcus Mest, Douglas Daro‐Kaftan, Elizabeth Hamilton, Tiffani Pierone, Gerald Condoluci, David LaMarca, Anthony Humble, Gail Blick, Gary Eviatar, Joseph Gold, Michael H. Bassichis, Benjamin Echavez, Michael
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Notes	This study was funded by Dermik Laboratories, a business of sanofi‐aventis U.S. LLC, A SANOFI COMPANY. All authors, with the exception of Elizabeth Daro‐Kaftan, PhD, were paid investigators. Editorial support was provided by Elizabeth Daro‐Kaftan, PhD, of Peloton Advantage, LLC. The authors were fully responsible for the content, editorial decisions, and opinions expressed in the current article. No author received an honorarium related to the development of this manuscript . ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 ObjectType-Article-2 ObjectType-Feature-1
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Snippet	Background Studies of injectable poly‐l‐lactic acid (PLLA) in human immunodeficiency virus (HIV)‐associated facial lipoatrophy have predominantly included male... Studies of injectable poly-L-lactic acid (PLLA) in human immunodeficiency virus (HIV)-associated facial lipoatrophy have predominantly included male... Studies of injectable poly-l-lactic acid (PLLA) in human immunodeficiency virus (HIV)-associated facial lipoatrophy have predominantly included male...
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SubjectTerms	Adipose Tissue - pathology Adult Aged Atrophy Cosmetic Techniques Female HIV Infections - complications Human immunodeficiency virus Humans Immunodeficiency Injections Lactic Acid - administration & dosage lipoatrophy Male Middle Aged Nodules Patient Satisfaction Polyesters Polylactic acid Polymers - administration & dosage Sex Skin Tea Tetraethylammonium
Title	Injectable Poly‐l‐Lactic Acid for Human Immunodeficiency Virus–Associated Facial Lipoatrophy: Cumulative Year 2 Interim Analysis of an Open‐Label Study (FACES)
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