Physicians from leading plastic surgery and dermatology practices report positive results from HIV patients participating in a clinical trial of Radiesse synthetic injectable implant on facial wasting. The trial is intended to demonstrate the safety and effectiveness of this widely used tissue augmentation therapy as a treatment for the facial changes that socially stigmatize many HIV-infected patients.
Lipoatrophy, or facial wasting, is a condition caused by loss of fat tissue under the skin of the cheeks resulting in a gaunt appearance. It is often associated with the anti-retroviral therapies taken by HIV patients, and, in some cases, is so severe that patients discontinue therapy. Radiesse, developed by BioForm Medical, Inc., is being tested for restoration of facial volume in patients with Lipoatrophy and to assess patient satisfaction and improvement in quality of life. An estimated 150,000 to 350,000 patients may benefit from such treatment.
"Facial wasting continues to have a debilitating effect on many HIV patients' appearance causing them to withdraw from normal social activities," stated Stacey L. Silvers, M.D., practicing facial plastic surgeon in New York, N.Y. "This new application of Radiesse may provide an immediate and potentially prolonged effect compared to other available treatments, resulting in enhanced quality of life."
The FDA has already approved Radiesse for vocal fold augmentation and certain plastic surgery reconstruction applications. It is also being tested in a trial for the treatment of nasolabial folds.
"I was interested in this study, because I knew of Radiesse's success in other tissue bulking uses, and I never questioned its safety," added Silvers. "I have found the end results more natural than any other injectable filler on the market."