• Archives of Plastic Surgery
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• v.42 no.6
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• pp.721-728
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• 2015

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.

• Journal of the Korean Society of Laryngology, Phoniatrics and Logopedics
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• v.15 no.1
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• pp.43-47
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• 2004

When a person was suffered from vocal cord paralysis or glottic insufficiency, injection materials (e.g Teflon, Bovine collagen, Autologous fat & tendon, Gelfoam) into the vocal cord have been widely used. But each injection material has some disadvantage. We introduce the Restylane which is composed of a hyaluronic acid, artificially producted. It has advantage of rate foreign body reaction, proper endurance, easy to injection. The patient was 55-year-old woman who showed left vacal cord paralysis after pneumonectomy due to aspergillosis, taken the type I thyroplasty and arytenoid adduction. The middle portion of left vocal cord has some atropic mucosal change, slight chink was noted. The restylane injection into vocal cord was done with suspension laryngoscopy under general anesthesia. In the 3 month follow-up after Restylane injection, the quality of voice has been better progressively. We report a case of Restylane injection as a new method for the improvement of quality of voice.

• Archives of Plastic Surgery
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• v.38 no.1
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• pp.1-6
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• 2011

Purpose: Currently, soft tissue filler products based on hyaluronic acid are widely used. They are safe, effective, and convenient to use compared with bovine collagens. However, all commercially available hyaluronic acid based fillers in Korea are imported ones. The purpose of this study is to evaluate efficacy of a new hyaluronic acid filler (HyaFilia; CHA bio&Diostech Co., Seoul), which has been recently developed in Korea. Methods: Three kinds of soft tissue fillers, including Restylane (Q-Med, Uppsala, Sweden), HyaFilia (CHA bio & Diostech Co., Seoul), Juvederm (Allergan, CA, USA), were injected subdermally into the back of hairless mice at six sites. The 2 cephalic sites composed Restylane groups, the 2 middle sites HyaFilia groups, and the 2 caudal sites Juvederm groups. Six hairless mice were included in the study, therefore, a total of 12 injections per group were performed. After 16 weeks after injection, the nodular swellings that resulted from the injections were excised wide enough to include skin beyond the swelling points down to the panniculus carnosus layer using 8mm punches. Volumes and weights were measured using a stereoimage optical topometer system and a weighting machine. Histologic comparisons were also carried out. Results: The mean volumes of the Restylane, HyaFilia and Juvederm groups were $3698{\times}103$, $4820{\times}103$, and $1435{\times}103$ PI, respectively. The mean weights of the Restylane, HyaFilia and Juvederm groups were 36.08, 37.83, and 24.66 mg, respectively. Histologic examination between the 3 groups showed no significant difference in tissue compositions and inflammatory reactions. Conclusion: The results of this study shows that HyaFilia is superior to Restylane and Juvederm in longavity of filling effect. Therefore, HyaFilia may be an effective replacement for the imported materials including Restylane and Juvederm.

• Maxillofacial Plastic and Reconstructive Surgery
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• v.41
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• pp.47.1-47.10
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• 2019

Background: Hyaluronic acid (HA) has been applied as a primary biomaterial for temporary soft tissue augmentation and as a carrier for cells and the delivery of growth factors to promote tissue regeneration. Although HA derivatives are the most versatile soft tissue fillers on the market, they are resorbed early, within 3 to 12 months. To overcome their short duration, they can be combined with cells or growth factors. The purpose of this study was to investigate the stimulating effects of human fibroblasts and basic fibroblast growth factors (bFGF) on collagen synthesis during soft tissue augmentation by HA hydrogels and to compare these with the effects of a commercial HA derivative (Restylane^®). Methods: The hydrogel group included four conditions. The first condition consisted of hydrogel (H) alone as a negative control, and the other three conditions were bFGF-containing hydrogel (HB), human fibroblast-containing hydrogel (HF), and human fibroblast/bFGF-containing hydrogel (HBF). In the Restylane^® group (HGF), the hydrogel was replaced with Restylane^® (R, RB, RF, RBF). The gels were implanted subdermally into the back of each nude mouse at four separate sites. Twelve nude mice were used for the hydrogel (n = 6) and Restylane^® groups (n = 6). The specimens were harvested 8 weeks after implantation and assessed histomorphometrically, and collagen synthesis was evaluated by RT-PCR. Results: The hydrogel group showed good biocompatibility with the surrounding tissues and stimulated the formation of a fibrous matrix. HBF and HF showed significantly higher soft tissue synthesis compared to H (p < 0.05), and human collagen type I was well expressed in HB, HF, and HBF; HBF showed the strongest expression. The Restylane^® filler was surrounded by a fibrous capsule without any soft tissue infiltration from the neighboring tissue, and collagen synthesis within the Restylane^® filler could not be observed, even though no inflammatory reactions were observed. Conclusion: This study revealed that HA-based hydrogel alone or hydrogel combined with fibroblasts and/or bFGF can be effectively used for soft tissue augmentation.

• Archives of Plastic Surgery
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• v.32 no.5
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• pp.593-598
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• 2005

Although several suspension biomaterials have been considered to be relatively safe and convenient, varying degrees of resorption have required repeated percutaneous injection. In the previous animal study the authors have reported that cultured human fibroblasts suspended in $Restylane^{(R)}$, which is modified hyaluronic acid, could produce human dermal matrices and prolong the effect of this gel. This study was undertaken to evaluate the clinical efficacy of this method. A total of 11 patients ranging from 25 to 57 years of age were included in this study between January of 2002 and December of 2003. All the patients were treated for the purpose of augmentation rhinoplasty. $1{\times}10^7/ml$ or $1.5{\times}10^7/ml$ cultured fibroblasts were suspended in 0.7 to 1.4 ml of $Restylane^{(R)}$. The implants were transferred to a 1-ml syringe and injected subcutaneously to the nose of the patients. Among 11 patients, long term follow-up for more than 1 year was possible in 6 patients. The injected implants remained in site without evidence of resorption or loss of correction. All the patients were satisfied with long term results of this method. There was no complication during the follow-up period.

• Archives of Plastic Surgery
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• v.42 no.3
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• pp.282-287
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• 2015

Background Morphological changes that accompany aging, such as wrinkles and skin laxity, are particularly prominent on facial skin. Recently, facial rejuvenation using the hydrofilling effect of hyaluronic acid (HA) filler has been employed for improvement of skin texture. In this study, we studied rejuvenating effects of stabilized HA (Restylane Vital) through direct intradermal injections. Methods A total of 30 female patients underwent a series of procedures on face, including three sessions at intervals of four weeks. A total of 2 mL of Restylane Vital was injected along the whole face using an automatic injector. Improvement of skin surface roughness, elasticity, brightness, moisture, and fine wrinkles was evaluated. Patient satisfaction was evaluated, and pictures of patients were taken at each visit and 6 months after last treatment session. Scoring for each patient was performed by three doctors according in five subjects. Moisture, oil and elasticity were measured before the procedure and before the last treatment in 10 patients. Results The majority of patients (77%) were satisfied with the therapeutic outcomes. Approximately 66% of patients responded that the effects of this procedure persisted for longer than four months, and the majority of patients (77%) wanted to undergo this procedure again and would recommend this procedure to acquaintances. Regarding doctors' evaluation, scores for improvement of skin surface roughness, elasticity, and brightness were significantly higher than those for improvement of moisture and fine wrinkle. Conclusions Intradermal injection of HA can have a rejuvenating effect on dry and tired facial skin, especially in improvement of skin surface roughness.

• Journal of Microbiology and Biotechnology
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• v.25 no.3
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• pp.399-406
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• 2015

In this study, we developed a composite filler comprising cross-linked hyaluronic acid (HA) and human collagen (COL) derived from the human umbilical cord with the aim of improving its biocompatibility and longevity compared with commercially available fillers. After HA/COL composite fillers were made in two different ratios (10:1 and 5:1), the physical properties of the fillers were evaluated. The interior morphologies and in vivo weight change of these hydrogels were also characterized at 1-16 weeks after injection into mice. To evaluate their biocompatibility and durability in vivo, we injected the composite fillers into nude mice subcutaneously. The variations of injected gel weight were measured and compared with the commercial dermal fillers (Restylane and TheraFill). The composites showed improved or similar physical properties (complex viscosity of 19-22 × 10⁵ cP, and injection force of 10-12 N) over the commercial dermal fillers. Sixteen weeks following the injection, the ratio of remaining composite filler weight to initial weight (75.5 ± 16.9%; 10:1) was shown to be greater than that of the commercial fillers (43.2 ± 8.1%, Restylane; 12.3 ± 5.3%, TheraFill). In addition, immunohistochemical analysis with angiogenesis-related markers such as isolectin and vWF revealed newly formed blood vessels and cellular influx into the composite filler, which were not observed in the other fillers. These results clearly suggest that the HA/COL composite filler is a superior candidate for soft tissue reconstruction. The filler we developed may be a suitable candidate as an injectable dermal filler for tissue augmentation in humans.

• Archives of Plastic Surgery
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• v.39 no.1
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• pp.51-54
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• 2012

With the gradual increase of cases using fillers, cases of patients treated by non-medical professionals or inexperienced physicians resulting in complications are also increasing. We herein report 2 patients who experienced acute complications after receiving filler injections and were successfully treated with adipose-derived stem cell (ADSCs) therapy. Case 1 was a 23-year-old female patient who received a filler (Restylane) injection in her forehead, glabella, and nose by a non-medical professional. The day after her injection, inflammation was observed with a $3{\times}3cm$ skin necrosis. Case 2 was a 30-year-old woman who received a filler injection of hyaluronic acid gel (Juvederm) on her nasal dorsum and tip at a private clinic. She developed erythema and swelling in the filler-injected area A solution containing ADSCs harvested from each patient's abdominal subcutaneous tissue was injected into the lesion at the subcutaneous and dermis levels. The wounds healed without additional treatment. With continuous follow-up, both patients experienced only fine linear scars 6 months postoperatively. By using adipose-derived stem cells, we successfully treated the acute complications of skin necrosis after the filler injection, resulting in much less scarring, and more satisfactory results were achieved not only in wound healing, but also in esthetics.

• Journal of the Korean Society of Laryngology, Phoniatrics and Logopedics
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• v.26 no.2
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• pp.112-116
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• 2015

Background and Objectives : Aerodynamic analysis is an examination which provides information regarding various vocalization measures indicating laryngeal efficiency. Voice evaluation using such examination must be capable of distinguishing between normal to abnormal voice. It also observes variables on aerodynamic characteristics by gender in regards to patients of vocal disorders, especially of vocal cord paralysis and vocal polyp, and compares the conditions before and after surgery. This paper therefore, seeks to build a framework for establishing standard levels of aerodynamical characteristic on vocal disorders. Subjects and Methods : The study was intended for a total number of 20 patients with vocal polyp or unilateral vocal cord paralysis. Those with the vocal polyp underwent laryngomycroscopy surgery and the vocal cord paralysis, vocal fold injection using Restylane. Aerodynamic analysis fulfilled the Maximum sustained Phonation (MXPH) and Voicing Efficiency (VOEF) by using PAS Model 6600 (KayPENTAX, USA). Results : In MXPH, increase in PHOT were evident with vocal polyp after surgery. As for patients with vocal cord paralysis, MAXDB, MEADB, DHODB, PHOT all have increased and MEAP, PEF, MEAF decreased after surgery. In VOEF, patients with vocal cord paralysis who underwent surgery showed increase in MAXDB, MEADB, DHODB, FET100, ARES, but decreases in PEF, TARF. Conclusion : Overall, it can be concluded that patients with the vocal polyp and vocal cord paralysis seemed to get closer to the normal values after than before surgery in majority of measures. This confirms that the function of their vocal cord has improved nearly to normality through operations.