| 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. | |
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MedLine Citation:
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PMID: 16936543 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: 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. METHODS: 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). RESULTS: 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. CONCLUSIONS: 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. |
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Authors:
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Stacey L Silvers; Joseph A Eviatar; Michael I Echavez; Alexandra L Pappas |
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Publication Detail:
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Type: Clinical Trial; Journal Article; Multicenter Study |
Journal Detail:
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Title: Plastic and reconstructive surgery Volume: 118 ISSN: 1529-4242 ISO Abbreviation: Plast. Reconstr. Surg. Publication Date: 2006 Sep |
Date Detail:
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Created Date: 2006-08-28 Completed Date: 2006-10-02 Revised Date: 2011-02-16 |
Medline Journal Info:
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Nlm Unique ID: 1306050 Medline TA: Plast Reconstr Surg Country: United States |
Other Details:
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Languages: eng Pagination: 34S-45S Citation Subset: AIM; IM |
Affiliation:
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Chelsea Eye and Cosmetic Surgery Associates, New York, NY 10011, USA. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adult Anthropometry Biocompatible Materials / administration & dosage, adverse effects, therapeutic use* Cheek Cosmetic Techniques* / adverse effects Durapatite / administration & dosage, adverse effects, therapeutic use* Ecchymosis / etiology Esthetics Female Follow-Up Studies HIV-Associated Lipodystrophy Syndrome / pathology, therapy* Humans Injections, Subcutaneous Male Microspheres Middle Aged Patient Satisfaction Prospective Studies Severity of Illness Index Treatment Outcome |
| Chemical | |
Reg. No./Substance:
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0/Biocompatible Materials; 1306-06-5/Durapatite |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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