title: Calcium Hydroxylapatite With Integral Lidocaine Provides Improved Pain Control for the Correction of Nasolabial Folds.
abstract: Calcium hydroxylapatite microspheres in a carrier gel (CaHA; Radiesse®: Merz North America, Inc., Raleigh, NC) is approved by the United States Food and Drug Administration for subdermal implantation for the correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds (NLFs). Lidocaine is often mixed with injectable dermal fillers to reduce injection pain. A new formulation of CaHA has been developed with the convenience of integral 0.3% lidocaine, CaHA (+).<br /> This multicenter, split-face, double-blind study randomized subjects to receive treatment with CaHA (+) in one NLF and CaHA without lidocaine in the contralateral NLF. The pain level for each NLF was evaluated immediately following the injection using a 10-cm visual analog scale (VAS), and every 15 minutes for 60 minutes plus follow-up visits. Additional endpoints included aesthetic outcomes and subject preference. All subjects (N=102) received treatment.<br /> CaHA (+) treatment resulted in a statistically and clinically significant reduction in pain ratings immediately after injection compared with CaHA. The mean difference in VAS scores for pain was -4.41 (<em>P</em>&lt;0.0001). In 90% of subjects, the VAS scores were ≥2.0 cm lower for the CaHA (+)-treated NLF. A significant reduction in pain ratings throughout the first hour after injection was observed with CaHA (+) compared with CaHA (<em>P</em>&lt;0.0001). Both treatment groups achieved significant aesthetic improvement; however, the pain differential resulted in a subject-reported preference for CaHA (+). CaHA (+) with integral lidocaine significantly reduces pain and is as effective as CaHA.<br /><br /> <em>J Drugs Dermatol</em>. 2016;15(8):1005-1010.
authors.forename: Daniel
authors.initials: D
authors.lastname: Schachter
authors.forename: Vince
authors.initials: V
authors.lastname: Bertucci
authors.forename: Nowell
authors.initials: N
authors.lastname: Solish
mesh_terms: D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D004337:Drug Carriers / Q000008:administration & dosage*; D004343:Drug Implants; D017886:Durapatite / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008012:Lidocaine / Q000008:administration & dosage*; D008297:Male; D008863:Microspheres; D008875:Middle Aged; D060052:Nasolabial Fold / Q000473:pathology; D059408:Pain Management / Q000379:methods*; D010147:Pain Measurement / Q000187:drug effects / Q000379:methods; D015595:Skin Aging / Q000187:drug effects* / Q000473:pathology
chemical_list: D004337:Drug Carriers; D004343:Drug Implants; D017886:Durapatite; D008012:Lidocaine