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

Abstract

The long-term effectiveness and safety of hyaluronic acid fillers in mid-face volume restoration in Asians remain unclear. The objective of this study was to compare the longterm effectiveness and safety of Neuramis Volume Lidocaine (SHAPE-NVL) and Juvederm Voluma with Lidocaine (VYC-20L) in mid-face volume restoration in Asians. Overall, 88 Korean subjects with moderate-to-severe age-related mid-face volume deficit on the Mid-Face Volume Deficit Scale (MFVDS) received SHAPE-NVL on one side and VYC-20L on the contralateral side of the face. Of the 81 subjects who completed the 48-week primary study, 69 subjects were enrolled in an extension study lasting 104 weeks. MFVDS score and global aesthetic improvement were assessed at each visit. Response was defined as a ≥1-point reduction in MFVDS. At weeks 36 and 48, the responder rates for SHAPE-NVL were 81.93% and 80.72%, while those for VYC-20L were 85.54% and 81.92%, respectively. At the 104-week visit, the responder rates were 73.91% and 72.46% for SHAPE-NVL and VYC-20L, respectively. No subjects experienced any serious adverse events during the trial. SHAPE-NVL and VYC-20L showed comparable longevity and safety in mid-face volume restoration over 2 years in Asians. Both had durable effects for up to 2 years with minimal safety concerns.

Propriedades, eficácia e segurança do uso do ácido hialurônico em harmonização orofacial

“…Por fim, sobre as eventuais complicações que podem os pacientes passar após a injeção de ácido hialurônico, como demonstrados nos ensaios clínicos randomizados de Ogilvie, et al (2020) e Jung, et al (2021 que esses problemas se apresentam em torno de 20,2% a 51,14% dos casos. Dentre as reações adversas relatadas nos estudos, as mais comumente encontradas foram dor no local de aplicação, vermelhidão, edema, eritema, dureza, nódulos, coceira e hematoma.…”