Leslie Baumann1, Robert A Weiss2, Steven Grekin3, Rhoda Narins4, Michael Gold5, Lisa Donofrio6, Alessandra Nogueira7, Heather Shawcross8, Sarah Brown8, Jay H Mashburn7. 1. Baumann Cosmetic & Research Institute, Inc., Miami, Florida. 2. MD Laser, Skin, & Vein Institute, Hunt Valley, Maryland. 3. Grekin Skin Institute, Southfield, Michigan. 4. Dermatology Surgery & Laser Center, New York, New York. 5. Tennessee Clinical Research Center, Nashville, Tennessee. 6. Savin Center, New Haven, Connecticut. 7. Galderma Laboratories, L.P., Fort Worth, Texas. 8. Fishawack Communications, Knutsford, United Kingdom.
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) receivedinitial 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.
RCT Entities:
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.
Authors: Adele Sparavigna; Beatrice Tenconi; Andrea Maria Giori; Gilberto Bellia; Laura La Penna Journal: Clin Cosmet Investig Dermatol Date: 2019-01-17
Authors: Tomasz Stefura; Artur Kacprzyk; Jakub Droś; Marta Krzysztofik; Oksana Skomarovska; Marta Fijałkowska; Mateusz Koziej Journal: Aesthetic Plast Surg Date: 2021-07-13 Impact factor: 2.708