Six-Month, Double-Blind, Randomized, Split-Face Study to Compare the Efficacy and Safety of Calcium Hydroxylapatite (CaHA) Mixed with Lidocaine and CaHA Alone for Correction of Nasolabial Fold Wrinkles

Abstract

BACKGROUND Safety, pain, duration of effect, and patient satisfaction are important concerns for physicians performing dermal filler injections. OBJECTIVE This randomized, double-blind, split-face study compared the 6-month safety profile of dermal injections of calcium hydroxylapatite (CaHA) mixed with lidocaine (RDF-L) with that of CaHA alone (RDF) in nasolabial folds (NLFs). The study also assessed differences in pain perception, efficacy, and patient satisfaction of RDF-L and RDF for correction of nasolabial wrinkles. METHODS Sixteen adult subjects with moderate to deep NLFs according to the Lemperle Rating Scale were enrolled. Pain perception was recorded from patients using a validated visual analog pain scale. Efficacy judged by a blinded injector and an independent observer was evaluated up to 24 weeks. Patient satisfaction surveys were also collected. Adverse events were recorded throughout the study. RESULTS/CONCLUSIONS Neither RDF-L nor RDF led to significant adverse events. Comparable and limited local adverse events typical of dermal fillers were noted in both groups. No difference in duration of effect in the NLFs was shown between RDF-L and RDF. Much less pain was reported on the RDF-L side. In general, patients were extremely satisfied with the treatment on both sides. BioForm Medical (San Mateo, CA) provided Radiesse soft tissue filler, lidocaine, and other necessary supplies. Dr. Grunebaum has received compensation for presentations to the medical community about products manufactured by BioForm Medical.