Calcium hydroxylapatite versus nonanimal stabilized hyaluronic acid for the correction of nasolabial folds: a 12-month, multicenter, prospective, randomized, controlled, split-face trial.

ABSTRACT

BACKGROUND: Fillers continue to proliferate in dermatology. Rigorous clinical trials can help determine the advantages and disadvantages of these products as they come to market. OBJECTIVE: 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. METHODS AND MATERIALS 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. RESULTS: 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. CONCLUSION: CaHA was found to be significantly more effective than NASHA. At all time points, CaHA demonstrated longer lasting results and greater improvement than NASHA.