“A Multi‐center, randomized, double blinded, comparative study of two hyaluronic acid fillers for temporary restoration of mid‐face volume in Asians”

Abstract

Background There have been few studies using hyaluronic acid fillers to restore mid‐face volume deficit especially in Asians. Aims This study compared the efficacy and safety of two highly cohesive hyaluronic acid fillers, Neuramis® Volume Lidocaine and Juvederm® Voluma® with Lidocaine (VYC‐20L), for temporary restoration of mid‐face volume in Asians. Patients/Methods A total of 88 subjects with moderate to severe age‐related mid‐face volume deficit on the Mid‐Face Volume Deficit Scale (MFVDS) received Neuramis® Volume Lidocaine on one side and VYC‐20L on the other side of the face. Response was defined as a ≥1 point reduction in MFVDS at 24 weeks after the injection by photographic assessment. Secondary end points included photographic and live assessments of MFVDS and its changes at week 4, 12, and 24; global aesthetic improvements, as assessed by the investigators and the subjects at each visit; and the proportion of subjects who received touch‐up treatment. Results The response rates of the sides treated with Neuramis® Volume Lidocaine and VYC‐20L were identical (96.39%) at week 24, demonstrating that Neuramis® Volume Lidocaine was noninferior to VYC‐20L. Photographic and live assessments of MFVDS and its changes, global aesthetic improvement, and the proportion of subjects who received touch‐up treatment did not differ significantly during follow‐up. Conclusions Neuramis® Volume Lidocaine was not inferior to VYC‐20L in temporarily restoring mid‐face volume at 24 weeks after treatment. Both of these highly cohesive hyaluronic acid fillers can be used effectively and safely for the correction of mid‐face volume loss in Asians.

A multicenter, randomized, double‐blind comparison of two hyaluronic acid fillers in mid‐face volume restoration in Asians: A 2‐year extension study

“…In our original 24-week study, both fillers showed similar effectiveness and safety profile for temporary restoration of mid-face volume in Asians. 13 In this study, the responder rates based on MFVDS in the mid-face 48 weeks after the final treatment were 81.93% and 80.72% for SHAPE-NVL and VYC-20L, respectively. These rates were slightly lower than those in previous studies with VYC-20L, which reported a responder rate of 85.2% 48 weeks after treatment.…”

“…The MFVDS assesses the degree of MVD and validated by previous studies. 5,7,13 Subjects who had recently received anticoagulant therapy or antiplatelet therapy (within 10 days) or were hypersensitive to HA or local anesthetics, were excluded. Subjects with asymmetric MVD, history of facial procedures such as plastic surgery, tissue grafting, tissue augmentation using hydroxyethylmethacrylate, dextran, or polylatic acid, or facial scar interfering with accurate assessment by the investigator were also excluded.…”

“…Regardless of sex and ethnicity, subjects aged between 35 and 65 years seeking mid‐face augmentation to correct bilaterally symmetrical, moderate‐to‐severe age‐related MVD on the Mid‐Face Volume Deficit Scale (MFVDS) 5,13 were recruited. The MFVDS assesses the degree of MVD and validated by previous studies 5,7,13 . Subjects who had recently received anticoagulant therapy or antiplatelet therapy (within 10 days) or were hypersensitive to HA or local anesthetics, were excluded.…”

“…Medytox, Inc., Seoul, Republic of Korea) with those of VYC-20L in temporary restoration of mid-face volume. 13 SHAPE-NVL is a highly cohesive, long-lasting HA filler produced with distinct double cross-linking technology (SHAPE technology). 14 This property makes the filler suitable for the correction of age-related volume loss when solid and substantial volumizing effect is required.…”

“…[10][11][12] Recently, we reported a multi-center, randomized, double-blind, splitface, 24-week clinical trial of 88 Korean subjects that compared the effectiveness and safety of Neuramis Volume Lidocaine (SHAPE-NVL; Medytox, Inc., Seoul, Republic of Korea) with those of VYC-20L in temporary restoration of mid-face volume. 13 SHAPE-NVL is a highly cohesive, long-lasting HA filler produced with distinct double cross-linking technology (SHAPE technology). 14 This property makes the filler suitable for the correction of age-related volume loss when solid and substantial volumizing effect is required.…”