Multicenter, Randomized Trial Assessing the Effectiveness and Safety of Calcium Hydroxylapatite for Hand Rejuvenation

OBJECTIVE To assess the safety and effectiveness of calcium hydroxylapatite (Radiesse Dermal Filler; RDF) for hand rejuvenation. METHODOLOGY One hundred and one randomized patients received RDF in the hands or no treatment (controls) for 3 months. Controls were crossed over at 3 months, and all patients were followed for 12 months. Assessments include the Busso Hand Volume Severity Scale (BHVSS), Global Aesthetic Improvement Scale-Revised (GAIS-R), patient satisfaction, physician satisfaction, hand function, and safety. RESULTS At 3 months and 6 months, 66% and 56% of hands, respectively, showed at least a 1-point improvement on the BHVSS. At the same time points, 89% and 75% of hands, respectively, were improved on the GAIS-R. In the controlled analysis, treated hands were statistically better than controls. At 3 and 6 months, 86% and 88% of physicians, respectively, and 78% and 76% of patients, respectively, were satisfied; 66% indicated likelihood to return for future RDF treatments. Treatment did not affect hand function. Adverse events were generally short in duration and without serious complications. CONCLUSIONS Hands treated with RDF showed statistically and clinically significant improvement, with high patient and physician satisfaction and no serious adverse events. BioForm Medical (San Mateo, CA) provided the Radiesse soft tissue filler, funding, supplies and equipment for photographic documentation for this study. Dr. Mariano Busso owns shares in BioForm Medical, Inc, is a member of the company's Medical Education Faculty, and has received compensation for presentations about Radiesse to the medical community. Dr. Marion Moers-Carpi owns no stock in BioForm but has received compensation for presentations about Radiesse to the medical community. The remaining physicians have nothing to disclose. David J. Howell, PhD, RRT (San Francisco, CA) provided assistance with editorial development of this manuscript.