Abstract
Fillers continue to proliferate in dermatology. Rigorous clinical trials can help determine the advantages and disadvantages of these products as they come to market. This randomized, split-face, controlled study compared the efficacy, safety, durability, and volumes of calcium hydroxylapatite (CaHA) versus nonanimal-stabilized hyaluronic acid (NASHA) in nasolabial folds. Sixty patients were enrolled at two medical clinics in Europe (Summer 2005). Patients received two injections 3 months apart. Patients returned at 6, 9, and 12 months for a blinded evaluation, using accepted aesthetic rating scales. Adverse events were recorded throughout the study. At all time points, CaHA was found to be more effective than NASHA. At 12 months, 79% of CaHA folds were still improved or better versus 43% of NASHA folds (p<.0001). In addition, 30% less total CaHA volume was required compared to NASHA. Evaluators assessed CaHA as superior in 47% of patients and inferior in only 5% (p<.0001). Blinded evaluators and patients preferred CaHA two to one (p<.05). Both products were safe and well tolerated. CaHA was found to be significantly more effective than NASHA. At all time points, CaHA demonstrated longer lasting results and greater improvement than NASHA.
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