Comparison of Hyaluronic Acid Gel With (HA: A Randomized, Evaluator-Blinded StudyRDL: A Randomized, Evaluator-Blinded Study) and Without Lidocaine (HA: A Randomized, Evaluator-Blinded StudyJUP: A Randomized, Evaluator-Blinded Study) in the Treatment of Moderate-To-Severe Nasolabial Folds: A Randomized, Evaluator-Blinded Study

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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.

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