Comparison of Hyaluronic Acid Gel With (HARDL) and Without Lidocaine (HAJUP) in the Treatment of Moderate-To-Severe Nasolabial Folds: A Randomized, Evaluator-Blinded Study. Issue 6 (June 2018)

• Record Type: Journal Article
• Authors: Baumann, Leslie; Weiss, Robert A.; Grekin, Steven; Narins, Rhoda; Gold, Michael; Donofrio, Lisa; Nogueira, Alessandra; Shawcross, Heather; Brown, Sarah; Mashburn, Jay H.
• Is Part Of: Dermatologic surgery. Volume 44:Issue 6(2018)
• Publication Date: 2018-06
• Subjects: Skin -- Surgery -- Periodicals; Skin -- Diseases -- Surgery -- Periodicals; 617.477
• DOI: 10.1097/DSS.0000000000001424
• Languages: English
• ISSNs: 1076-0512

Abstract

Abstract : BACKGROUND: Injectable fillers, such as those containing hyaluronic acid (HA), are increasingly used to smooth age-related facial creases and wrinkles. OBJECTIVE: To compare efficacy and safety of a HA gel with lidocaine formulated by XpresHAn Technology (HARDL ) with a HA gel without lidocaine produced by Hylacross technology (HAJUP ) in the treatment of moderate-to-severe nasolabial folds. MATERIALS AND METHODS: Subjects ( n = 162) received initial and touch-up injections with HARDL and HAJUP on either side of the face. Investigator- and subject-assessed wrinkle severity was measured up to 48 weeks after final injection. RESULTS: Mean (SD) Wrinkle Severity Rating Scale was improved by 1.1 (0.75) and 1.1 (0.68) with HARDL and HAJUP, respectively, at 24 weeks; improvements were sustained up to Week 48 with both treatments. Noninferiority of HARDL was demonstrated (mean difference −0.09 [95% confidence interval: −0.18 to −0.01], p = .032) at 24 weeks. Adverse events were reported in 43% subjects, 12% were treatment related, with a similar distribution for both treatments. CONCLUSION: Effectiveness and safety profiles of HARDL and HAJUP were comparable.