A Single-Center, Randomized, Double-Blind Clinical Trial to Compare the Efficacy and Safety of a New Monophasic Hyaluronic Acid Filler and Biphasic Filler in Correcting Nasolabial Fold.

BACKGROUND: Hyaluronic acid (HA) fillers have been widely used in humans since 1958 because of their biomedical safety. Restylane® was introduced in the1990s as a favorable temporary filler option for facial augmentation. Subsequently, many new HA filler products, including the Sardenyashape®, have been introduced, but comparative studies of these products are limited. Here, we compared tolerability (wrinkle severity rating scale, WSRS), pain (visual analog scale, VAS score), satisfaction (global esthetic improvement scale, GAIS), and safety of a new monophasic HA (MHA) filler (Sardenyashape®) containing lidocaine, used to correct nasolabial folds (NLFs), with those of biphasic HA (BHA) filler (Restylane LYFT®) containing lidocaine. METHODS: We enrolled 96 participants with visible NLFs in this randomized, double-blind, single-center clinical study. Participants were injected with a new MHA filler in one NLF and a BHA filler and were reassessed for cosmetic changes at 8 and 24 weeks. Wrinkle severity was assessed using the 5-point WSRS. RESULTS: At week 24, the mean improvement in WSRS compared to baseline was 1.92 ± 0.75 and 2.24 ± 0.66 for MHA and BHA fillers, respectively, and corresponding average pain values using the VAS score 30 min after the procedure were 0.04 ± 0.25 and 0.02 ± 0.15, respectively, showing no significant difference. Average GAIS values 8 weeks after the procedure with MHA and BHA fillers were 1.89 ± 0.77 and 1.40 ± 0.82, respectively (p < 0.001). Both fillers were well tolerated, with mild adverse reactions. CONCLUSION: The evaluation of the effect of Sardenyashape® with lidocaine on NLF in this study proved its effectiveness and safety for use in correcting NLF. LEVEL OF EVIDENCE II: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Extracellular Vesicles From a Three-Dimensional Culture of Perivascular Cells Accelerate Skin Wound Healing in a Rat.

BACKGROUND: Soluble proteins and extracellular vesicles (EVs) are crucial wound repair mediators in cell-based therapy. Previous studies reported that EVs of perivascular cells stimulated migration and proliferation of cell types involved in the dermatological wound healing process. However, these studies only show effects of EVs from perivascular cells (PVCs) for in vitro models. METHODS: EVs were collected from 3D-cultured PVC (PVC-3D-EV) and compared with EVs from 2D-culture PVC (PVC-2D-EV) to investigate effects on wound contraction, angiogenesis, activation of myofibroblast, and collagen deposition. RESULTS: PVC-3D-EV was significantly improved in terms of wound contraction compared with PVC-2D-EV and the control. Activation of myofibroblast and collagen deposition in a rat skin wound model was significantly stimulated by PVC-3D-EV. In addition, angiogenesis and vascular endothelial growth factor expression were also highly stimulated by PVC-3D-EV. These results suggest that PVC-3D-EV was regulated in granulation tissue formation, angiogenesis, and wound contraction in healing of a rat skin wound. These results indicate a pivotal role of PVC-3D-EV in wound healing through multiple mechanisms. CONCLUSIONS: 3D-culture using a polystyrene scaffold is demonstrated to be a better system for providing better physiological conditions than the 2D-culture system, and EVs from 3D-cultured PVC could be a promising option for healing skin wound. NO LEVEL ASSIGNED: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Lime application for the efficient production of nutraceutical glucooligosaccharides from Leuconostoc mesenteroides NRRL B-742 (ATCC13146).

We have previously demonstrated the production of glucooligosaccharides via a fermentation of sucrose with Leuconostoc mesenteroides NRRL B-742 using sodium hydroxide (NaOH) to control the pH. Because NaOH is expensive, we sought to minimize the cost of our process by substituting hydrated lime and saccharate of lime (lime sucrate) in its place. The yield of glucooligosaccharides using either 5 % lime (41.4 ± 0.5 g/100 g) or 5 % lime sucrate (40.0 ± 1.4 g/100 g) were both similar to the NaOH control (42.4 ± 1.5 g/100 g). Based on this, it appears that the cost associated with pH control in our process can be reduced by a factor of approximately 2.4 using lime instead of NaOH. Because our chromatographic stage is based on a Ca(2+)-form resin to separate glucooligosaccharides, the use of lime not only negates the need for costly de-salting via ion-exchange (elimination of two ion-exchange sections) prior to separation, but also greatly reduces the resin regeneration cost.

Sugarcane bagasse oxidation using a combination of hypochlorite and peroxide.

Reactive oxygen species (ROS) such as singlet oxygen ((1)O(2)), superoxide (O(2)(-)), hydroxyl radicals (OH(*)), or hypochlorite ion (OCl(-)), can remove both hemicellulose and lignin from lignocellulose. Ox-B (US Patent 6,866,870), an ROS producing solution containing sodium hypochlorite and hydrogen peroxide, was investigated for its ability to oxidize sugarcane bagasse. Treatment with equivalent amounts of hypochlorite produced similar results. Ox-B differentiated from hypochlorite when low concentration treatments were used and they were followed by a caustic wash. Cellulases hydrolyzed 80-100% of the cellulose present after Ox-B/caustic treatment compared to 40% or less for NaOCl/caustic treatment. Ox-B treatment was temperature independent and complete within 3h. It was pH dependent, with best results obtained when the pH was controlled at 8. Although highly effective, in order for Ox-B to be industrially feasible for alcohol production, the chemical cost must decrease to justify its use.