A Randomized Clinical Trial to Evaluate the Efficacy and Safety of Lidocaine-Containing Monophasic Hyaluronic Acid Filler for Nasolabial Folds

Joo, Hong Jin; Woo, Young Sup; Kim, Jung Eun; Kim, Beom Joon; Kang, Hoon

doi:10.1097/01.prs.0000479965.14775.f0

Cited by 21 publications

(17 citation statements)

References 17 publications

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“…This filler, developed by Medytox, is produced with distinct double cross-linking, called Stabilized Hyaluronic Acid & Purification Enhancement technology, which makes it highly cohesive. 13,14 The aim of this study was to compare the effectiveness and safety of Neuramis® Volume Lidocaine and VYC-20L for restoration of mid-face volume in Asians with moderate to severe MVD. Photographs of all subjects at each center were assessed by another independent blinded evaluator.…”

Section: Among Other Available Hyaluronic Acid Dermal Fillers Ismentioning

confidence: 99%

“…Among other available hyaluronic acid dermal fillers is Neuramis® Volume Lidocaine (Medytox, Inc, Seoul, Republic of Korea), a 20 mg/mL monophasic hyaluronic acid filler that incorporates 0.3% lidocaine. This filler, developed by Medytox, is produced with distinct double cross‐linking, called Stabilized Hyaluronic Acid & Purification Enhancement technology, which makes it highly cohesive . The aim of this study was to compare the effectiveness and safety of Neuramis® Volume Lidocaine and VYC‐20L for restoration of mid‐face volume in Asians with moderate to severe MVD.…”

Section: Introductionmentioning

confidence: 99%

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

Jung

Lee²,

Kim

et al. 2019

J of Cosmetic Dermatology

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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.

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Section: Among Other Available Hyaluronic Acid Dermal Fillers Ismentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

Jung

Lee²,

Kim

et al. 2019

J of Cosmetic Dermatology

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“… 10 , 12 , 13 , 16 , 19 , 31 , 33 External volume expansion has previously demonstrated an influence on histological structure of tissues, and has shown to increase adipogenic potential 10 , 17 in fat grafting, and potential utility in diabetic and radiation in small experimental animal models. 8 , 13 , 34 …”

Section: Discussionmentioning

confidence: 99%

Preconditioning with Foam-mediated External Suction on Flap Microvasculature and Perfusion in a Rodent Model

Mohan

Zhu

Michalak

et al. 2020

Plastic and Reconstructive Surgery - Global Open

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Background: Foam-mediated external suction (FMES) has previously shown to improve tissue microcirculation. We hypothesized that preconditioning fasciocutaneous perforator flaps with FMES would augment perfusion and demonstrate greater capillary recruitment. Methods: Gluteal perforator flaps were designed on sixteen 400 g rats. Continuous FMES at −125 mm Hg was applied on one side (intervention) to precondition tissue for 5 days, with the contralateral side as a paired control. In group A, we assessed changes following pretreatment, after surgery, and 7 days postprocedure, and in group B, we evaluated changes during preconditioning alone. In group A (N = 8), control and intervention flaps were assessed using laser-assisted indocyanine green fluorescence angiography. In group B, flap regions were assessed using 4-dimensional computed tomographic angiography. All flaps were analyzed for microvessel density using micro–computed tomography and histological assessment using hematoxylin and eosin and CD3 immunohistochemistry. Results: Thirty-two flaps were included in this study (N = 16 intervention and matched controls). Four-dimensional computed tomographic angiography demonstrated 17% greater tissue perfusion in preconditioned flaps (mean, 78.7 HU; SD, 8.8) versus controls (mean, 67.3 HU; SD, 15.7; P < 0.01). Laser-assisted indocyanine green fluorescence angiography showed a 30% higher mean absolute intensity in preconditioned flaps versus controls (P < 0.01). Postsurgery mean absolute intensity in preconditioned flaps remained 21% higher than in controls (P = 0.03). Preconditioned flaps demonstrated a 2-fold increase in mean vessel volume of 9.1 mm3 (SD, 7) versus 4.5 mm3 (SD, 3) in controls (P = 0.04); there was a 33% higher mean area fraction of CD31 in preconditioned flaps, 3.9% (SD, 3) versus 2.9% (SD, 3) in controls (P = 0.03). Conclusion: FMES preconditioning has the potential to augment vascularity of tissue for flap harvest; however, further experimental studies are required to optimize strategies and evaluate long-term effects for clinical applications.

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“…7 Hence, several randomized clinical studies have been conducted to evaluate the effectiveness and safety of lidocaine-containing HA filler for NLFs correction. [8][9][10] In this multicenter, double-blind, randomized controlled, splitface, clinical study, we tried to assess the effect on pain relief of HA with lidocaine, mainly focusing on a comparison of immediate and post-injection pain over the course of 1 hour in a group of Korean patients. We confirmed that 95% of patients reported reduced pain immediately after treatment.…”

Section: Discussionmentioning

confidence: 99%

Reduced pain with injection of hyaluronic acid with pre‐incorporated lidocaine for nasolabial fold correction: A multicenter, double‐blind, randomized, active‐controlled, split‐face designed, clinical study

Choi

Han

Yoo

et al. 2020

J of Cosmetic Dermatology

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Background Injection of hyaluronic acid (HA) filler for nasolabial fold (NLF) correction is a popular aesthetic procedure. In relation to HA filler injections, effective pain control for patient comfort is an important concern. Objectives We compared the pain relief achieved by HA filler with 0.3% lidocaine (HAF‐Lidocaine) with that achieved by HA filler without lidocaine (HAF) for NLF correction. Patients/Methods A total of 62 subjects with visible NLFs were enrolled in this double‐blind study at two university hospitals and injected with HAF‐Lidocaine and HAF, randomly assigned to the each NLFs. Subjects assessed pain using the visual analog scale (VAS). Blinded independent dermatologists assessed the Wrinkle Severity Rating Scale (WSRS) and subjects assessed the Global Aesthetic Improvement Scale (GAIS) for the evaluation of effectiveness. All adverse events during the follow‐up period were recorded. Results Immediately after treatment, 95.2% of subjects who were treated with HAF‐Lidocaine reported reduced pain when compared with those who were treated with HAF and the mean VAS score difference was 38.6 mm. At 15, 30, 45, and 60 minutes after treatment, respectively, 67.7%, 41.9%, 32.3%, and 21.0% of subjects experienced reduced pain. Based on the mean WSRS and GAIS scores and the incidence of local injection site reactions, the clinical effectiveness and safety profile of HAF‐Lidocaine were comparable to those of HAF. Conclusion We conclude that HA filler containing pre‐incorporated lidocaine could reduce pain in Korean patients for NLF correction, and the addition of lidocaine does not affect the effectiveness and safety of HA filler.

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A Randomized Clinical Trial to Evaluate the Efficacy and Safety of Lidocaine-Containing Monophasic Hyaluronic Acid Filler for Nasolabial Folds

Abstract: Therapeutic, I.

Cited by 21 publications

References 17 publications

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

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

Preconditioning with Foam-mediated External Suction on Flap Microvasculature and Perfusion in a Rodent Model

Reduced pain with injection of hyaluronic acid with pre‐incorporated lidocaine for nasolabial fold correction: A multicenter, double‐blind, randomized, active‐controlled, split‐face designed, clinical study

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