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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

Baumann, Leslie, MD*; Weiss, Robert A., MD; Grekin, Steven, DO; Narins, Rhoda, MD, PC, FAAD§; Gold, Michael, MD, FAAD; Donofrio, Lisa, MD; Nogueira, Alessandra, MD#; Shawcross, Heather, PhD**; Brown, Sarah, BSc (Hons), CMPP**; Mashburn, Jay H., PhD#

doi: 10.1097/DSS.0000000000001424
Original Article
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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.

*Baumann Cosmetic & Research Institute, Inc., Miami, Florida;

MD Laser, Skin, & Vein Institute, Hunt Valley, Maryland;

Grekin Skin Institute, Southfield, Michigan;

§Dermatology Surgery & Laser Center, New York, New York;

Tennessee Clinical Research Center, Nashville, Tennessee;

Savin Center, New Haven, Connecticut;

#Galderma Laboratories, L.P., Fort Worth, Texas;

**Fishawack Communications, Knutsford, United Kingdom

Address correspondence and reprint requests to: Jay H. Mashburn, PhD, Galderma Laboratories, L.P., 14501 N. Freeway, Fort Worth, TX 76177, or e-mail: jay.mashburn@galderma.com

Supported by Galderma. A. Nogueira and J.H. Mashburn are employees of Galderma. Medical writing assistance was provided by H. Shawcross and S. Brown of Fishawack Communications, funded by Galderma.

R. Weiss has received support for clinical research and has served as a consultant for Galderma. M. Gold, S. Grekin, and R. Narins have received support from Galderma for clinical research. L. Donofrio has received support for clinical research, served as a consultant, and participated in advisory boards for Galderma. L. Baumann has served as a primary investigator for Galderma.

© 2018 by the American Society for Dermatologic Surgery, Inc. Published by Wolters Kluwer Health, Inc. All rights reserved.
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