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

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.

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.

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.

Rheologic and Physicochemical Properties Used to Differentiate Injectable Hyaluronic Acid Filler Products.

BACKGROUND: Injectable hyaluronic acid fillers are routinely used for correction of soft-tissue volume loss and facial rejuvenation. Product differentiation has primarily been based on the rheologic parameter known as elastic modulus (G'), although other physicochemical properties are being explored to characterize potential product performance. As clinical data regarding product performance are lacking, the practical experience of injectors provides a valuable bridge in the knowledge gap between product rheologic data and product use. METHODS: Rheologic and physicochemical measurements (swelling factor and cohesion) were collected for 18 products. To observe the impact of G' and hyaluronic acid concentration on swelling factor and cohesion, proportional relationships were evaluated. Contributing authors were queried regarding their G'-based selection of products when considering skin quality, degree of correction, injection depth, and anatomical location. RESULTS: Relationships were observable between G' and swelling factor and G' and cohesion only when limited to products manufactured by the same crosslinking technology and the same concentration. No relationship between isolated hyaluronic acid concentration and swelling factor or cohesion was apparent. Although rheological parameters and the assumptions of ex vivo data translating to in vivo performance are oftentimes not completely aligned, in the clinical experience of the authors, in general, higher G' products are better suited for thicker skin and deeper injection planes, whereas lower G' products are better for more superficial planes, although exceptions to these trends are also made based on technical experience. CONCLUSIONS: While rheologic and physicochemical characteristics can vary widely between products and the methods and measurements of these parameters are often difficult to correlate, G' represents a useful and consistent parameter for product differentiation. Understanding how to select products based on G' is valuable knowledge for customizing injection plans and contributes to an optimal aesthetic outcome.