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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

Silvers, Stacey L. M.D.; Eviatar, Joseph A. M.D.; Echavez, Michael I. M.D.; Pappas, Alexandra L. M.D.

Plastic and Reconstructive Surgery: September 1, 2006 - Volume 118 - Issue 3S - p 34S-45S
doi: 10.1097/01.prs.0000234847.36020.52

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.

New York, N.Y.; and San Francisco, Calif.

From Chelsea Eye and Cosmetic Surgery Associates, and St. Vincent's Catholic Medical Center.

Received for publication February 9, 2006; accepted May 12, 2006.

Radiesse is approved by the FDA for soft-tissue augmentation applications, including the treatment of oral/maxillofacial defects, vocal fold medialization and augmentation, and as a tissue marker; other uses are “off-label.” Radiesse is currently under review by the FDA for facial soft-tissue augmentation applications.

Joseph A. Eviatar, M.D., Chelsea Eye and Cosmetic Surgery Associates, 157 W 19th Street, New York, N.Y. 10011,

©2006American Society of Plastic Surgeons