Clinical Trial of a Novel Filler Material for Soft Tissue Augmentation of the Face Containing Synthetic Calcium Hydroxylapatite Microspheres

Abstract

The ideal injectable filler should yield great, long-lasting results, be biocompatible, reliable, safe, easy to use, and inexpensive. Radiesse (Bioform Inc., Franksville, WI) is a synthetic calcium hydroxylaptic filler that has all of the above qualities. OBJECTIVE To evaluate the effectiveness of Radiese as an injectable filler. Eighty-two patients who underwent facial soft tissue augmentation using Radiese from April 2003 to 2004 were enrolled in this study. Pre-filled sterile syringes were used to inject the material into the soft tissues of the face. At the 3 month and six month visits, the physicians and the patients were asked to evaluate the result. Eighty-two patients were injected with Radiesse. The most common area of injection was the melolabial folds. All patients were evaluated during the 3 month follow up visit. There was an overwhelmingly positive response to the look and feel of the implant, averaging 4.6 on a grading scale from 1 to 5, for the patients as well as the injecting physicians. Similar responses were found at the 6 month follow up visit. Preliminary data indicate that Radiesse is easy to use and effective with little or no associated morbidity.