Injectable Poly-L-Lactic Acid for Human Immunodeficiency Virus-Associated Facial Lipoatrophy: Cumulative Year 2 Interim Analysis of an Open-Label Study (FACES)

被引：14

作者：

Bassichis, Benjamin ^{[2
]}

Blick, Gary ^{[3
]}

Conant, Marcus ^{[4
]}

Condoluci, David ^{[5
]}

Echavez, Michael ^{[6
,7
]}

Eviatar, Joseph ^{[8
]}

Gold, Michael H. ^{[9
]}

Hamilton, Tiffani ^{[10
]}

Hanke, C. William ^{[1
]}

Humble, Gail ^{[11
]}

LaMarca, Anthony ^{[12
]}

Daro-Kaftan, Elizabeth ^{[13
]}

Mest, Douglas ^{[11
]}

Pierone, Gerald ^{[14
]}

机构：

[1] Laser & Skin Surg Ctr Indiana, Carmel, IN 46032 USA

[2] Adv Facial Plast Surg Ctr, Dallas, TX USA

[3] Circle Med, Norwalk, CT USA

[4] Conant Med Grp, San Francisco, CA USA

[5] Garden State Infect Dis Associates, Voorhees, NJ USA

[6] Univ Calif San Francisco, San Francisco, CA 94143 USA

[7] Facial Plast Surg, San Francisco, CA USA

[8] New York Med Coll, New York, NY USA

[9] Gold Skin Care Ctr, Nashville, TN USA

[10] Vein & Res Ctr, Alpharetta, GA USA

[11] Blue Pacific Aesthet Med Grp, Hermosa Beach, CA USA

[12] Therafirst Med Ctr, Ft Lauderdale, FL USA

[13] Peloton Adv LLC, Parsippany, NJ USA

[14] Facial Rejuvenat, Vero Beach, FL USA

来源：

DERMATOLOGIC SURGERY | 2012年 / 38卷 / 07期

关键词：

NASOLABIAL FOLD WRINKLES; SOFT-TISSUE AUGMENTATION; HIV-POSITIVE PATIENTS; QUALITY-OF-LIFE; POLYLACTIC ACID; ANTIRETROVIRAL THERAPY; CALCIUM HYDROXYLAPATITE; HYALURONIC-ACID; ADVERSE EVENTS; EFFICACY;

D O I：

10.1111/j.1524-4725.2012.02474.x

中图分类号：

R75 [皮肤病学与性病学];

学科分类号：

100206 ;

摘要：

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 2years, 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 2years, 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.

引用

页码：1193 / 1205

页数：13

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