BACKGROUND: We conducted this clinical study to compare the efficacy and safety between Neuramis Deep and Restylane in the correction of nasolabial folds. METHODS: In this phase III, randomized, multi-center, double-masked, matched-pairs, active-controlled trial (ClinicalTrials.gov Identifier: NCT01585220), we evaluated a total of 67 subjects (n=67). All the subjects underwent Neuramis Deep treatment on one side and Restylane on the contralateral side of the bilateral nasolabial folds at a ratio of 1:1. To compare the efficacy of Neuramis Deep and Restylane, we evaluated the Wrinkle Severity Rating Scale scores and those of the Global Aesthetic Improvement Scale. In addition, we compared the safety of Neuramis Deep and Restylane based on adverse events, physical examination, and clinical laboratory tests. RESULTS: Neuramis Deep was not inferior in improving the nasolabial folds as compared with Restylane. In addition, there was no significant difference in the efficacy between Neuramis Deep and Restylane. There were no significant differences in safety parameters between Neuramis Deep and Restylane. CONCLUSIONS: In conclusion, our results indicate that Neuramis Deep may be a safe, effective material for improving the nasolabial folds. However, further studies are warranted to compare the tolerability of Neuramis Deep and Restylane based on histopathologic findings.
Hyaluronic Acid ; Nasolabial Fold* ; Physical Examination

OBJECTIVE: To determine the feasibility of labeling human mesenchymal stem cells (hMSCs) with bifunctional nanoparticles and assessing their potential as imaging probes in the monitoring of hMSC transplantation. MATERIALS AND METHODS: The T1 and T2 relaxivities of the nanoparticles (MNP@SiO2[RITC]-PEG) were measured at 1.5T and 3T magnetic resonance scanner. Using hMSCs and the nanoparticles, labeling efficiency, toxicity, and proliferation were assessed. Confocal laser scanning microscopy and transmission electron microscopy were used to specify the intracellular localization of the endocytosed iron nanoparticles. We also observed in vitro and in vivo visualization of the labeled hMSCs with a 3T MR scanner and optical imaging. RESULTS: MNP@SiO2(RITC)-PEG showed both superparamagnetic and fluorescent properties. The r1 and r2 relaxivity values of the MNP@SiO2(RITC)-PEG were 0.33 and 398 mM-1 s-1 at 1.5T, respectively, and 0.29 and 453 mM-1 s-1 at 3T, respectively. The effective internalization of MNP@SiO2(RITC)-PEG into hMSCs was observed by confocal laser scanning fluorescence microscopy. The transmission electron microscopy images showed that MNP@SiO2(RITC)-PEG was internalized into the cells and mainly resided in the cytoplasm. The viability and proliferation of MNP@SiO2(RITC)-PEG-labeled hMSCs were not significantly different from the control cells. MNP@SiO2(RITC)-PEG-labeled hMSCs were observed in vitro and in vivo with optical and MR imaging. CONCLUSION: MNP@SiO2(RITC)-PEG can be a useful contrast agent for stem cell imaging, which is suitable for a bimodal detection by MRI and optical imaging.
Animals ; Biocompatible Materials ; Cells, Cultured ; Cobalt ; Feasibility Studies ; Ferric Compounds ; Humans ; Magnetic Resonance Imaging/*methods ; *Mesenchymal Stem Cells ; Mice ; Mice, Nude ; Microscopy, Confocal ; Microscopy, Electron ; Nanoparticles/*chemistry ; Phantoms, Imaging ; Polyethylene Glycols ; Rats ; Rhodamines ; Silicon Dioxide ; Staining and Labeling/methods