Document Detail


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.
MedLine Citation:
PMID:  16936543     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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.
Authors:
Stacey L Silvers; Joseph A Eviatar; Michael I Echavez; Alexandra L Pappas
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study    
Journal Detail:
Title:  Plastic and reconstructive surgery     Volume:  118     ISSN:  1529-4242     ISO Abbreviation:  Plast. Reconstr. Surg.     Publication Date:  2006 Sep 
Date Detail:
Created Date:  2006-08-28     Completed Date:  2006-10-02     Revised Date:  2014-10-13    
Medline Journal Info:
Nlm Unique ID:  1306050     Medline TA:  Plast Reconstr Surg     Country:  United States    
Other Details:
Languages:  eng     Pagination:  34S-45S     Citation Subset:  AIM; IM    
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MeSH Terms
Descriptor/Qualifier:
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:
0/Biocompatible Materials; 91D9GV0Z28/Durapatite

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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