San Mateo, Calif. — The U.S. FDA has approved a method of mixing Radiesse dermal filler with lidocaine, which in clinical trials has demonstrated an improvement in patient comfort and an increase in patient satisfaction, reports Globe Newswire.

The technique for mixing Radiesse with lidocaine was first published in the Journal of Dermatologic Surgery in June 2008. BioForm conducted a 50-patient controlled clinical trial to evaluate the safety and effectiveness of the mixture. Patients in the split-face trial at two clinical sites reported that Radiesse mixed with 2 percent lidocaine was less painful than Radiesse alone, but that the aesthetic results were comparable. Among the trial’s findings were:

·     100 percent of patients found Radiesse mixed with lidocaine to be less painful than non-mixed Radiesse

·     96 percent found that the difference was significant enough to affect their preference for one treatment over the other

·     Both mixed and non-mixed Radiesse were found to have comparable local adverse events typical of dermal fillers. There were no serious adverse events in the clinical trial

·     Radiesse mixed with lidocaine produced comparable aesthetic results as compared with Radiesse used alone

The FDA-approved method is based on using a mixing syringe and the female-to-female luer lock connector to mix Radiesse and lidocaine. BioForm Medical officials say components for this technique are commercially available through various sources, but that the company will be providing the components in a separate accessory kit to its customers.