Hyaluronic Acid Gel With (HA: A Randomized, Evaluator-Blinded, Phase III StudyRRL: A Randomized, Evaluator-Blinded, Phase III Study) and Without Lidocaine (HA: A Randomized, Evaluator-Blinded, Phase III StudyJU: A Randomized, Evaluator-Blinded, Phase III Study) for the Treatment of Moderate-to-Severe Nasolabial Folds: A Randomized, Evaluator-Blinded, Phase III Study

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Abstract

BACKGROUND

Hyaluronic acid (HA) dermal fillers are frequently used to correct or smooth facial wrinkles and folds such as nasolabial folds.

OBJECTIVE

To compare the efficacy and safety of 2 HA gels, formulated by 2 different manufacturing processes: XpresHAn Technology (HARRL [with lidocaine]) and Hylacross technology (HAJU—a comparator product without lidocaine).

PATIENTS AND METHODS

One hundred seventy subjects with bilateral nasolabial folds rated as moderate or severe, according to the Wrinkle Severity Rating Scale (WSRS), received injections of HARRL in the nasolabial folds on one side of the face and HAJU on the other side. Investigator- and subject-assessed wrinkle severity was measured up to 48 weeks after final injection.

RESULTS

HARRL exhibited a similar safety and efficacy profile compared with HAJU. Noninferiority of HARRL was demonstrated at 24 weeks (WSRS mean change from baseline mean difference −0.1 [95% confidence interval: −0.15, 0.01], p = .090). Incidence of adverse events was 40% for both treatments.

CONCLUSION

HARRL exhibited a similar safety and efficacy profile compared with HAJU.

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