Restoring long-lasting midface volume in the Asian face with a hyaluronic acid filler: A randomized controlled multicenter study.

BACKGROUND: Hyaluronic acid (HA) filler treatment is a minimally-invasive alternative to surgery to volumize the cheeks. HAVOL (Restylane® Volyme) is a flexible HA filler suited to contouring and volumizing the midface. METHODS: This randomized, evaluator-blinded, no-treatment controlled study evaluated effectiveness and safety of HAVOL for correction of midface volume deficit and midface contour deficiency in Chinese subjects. In total 111 subjects were randomized to HAVOL and 37 to no treatment (control). The primary endpoint was response, on the blinded evaluator-assessed Medicis Midface Volume Scale (MMVS), at 6 months after last injection for the treatment group and 6 months after randomization for controls, where response was defined as ≥1-point improvement from baseline on both sides of the face. RESULTS: HAVOL was superior to no treatment at 6 months, meeting the primary objective: 76% versus 8% MMVS responders, a difference of 68% (CI: 55.7%-79.4%, p < 0.0001). These effects were sustained in 51% at 12 months after last injection. A majority (≥96%) had improved aesthetic appearance of midface fullness at Month 1 (using the Global Aesthetic Improvement Scale [GAIS]), effects which remained in ≥80% up to 12 months. Volume change captured by 3D photography increased after 1 month to 3.6 mL (close to the total injected volume of 3.4 mL), and remained stable through 12 months. Over 97% reported satisfaction with results after treatment with HAVOL. Additionally, HAVOL was well tolerated, with no unanticipated related adverse events. CONCLUSIONS: This study showed that HAVOL is effective and well tolerated for midface treatment in a Chinese population.

Safe and Effective Lip Enhancement with VYC-15L in Chinese Adults.

Background: Hyaluronic acid (HA) soft tissue fillers are used to restore volume loss to the lips and perioral area. Objective: Evaluate the safety and effectiveness of the HA filler Juvéderm® Volbella® (VYC-15L) for lip enhancement in Chinese adults. Methods & Materials: In this multicenter, evaluator-blind study, subjects seeking lip enhancement were randomized 3:1 to VYC-15L or no-treatment control group (with optional treatment delayed by 3 months). Effectiveness endpoints included 1-point improvement on the 5-point Lip Fullness Scale (LFS) assessed by evaluating investigators (EIs) and subjects, and overall volume of lips and change in lip surface area measured from 3-dimensional images. Safety assessments included procedural pain, injection site reactions (ISRs), and adverse events (AEs). Results: The modified intention-to-treat population included 163 subjects (median age, 34 years; 96.9% female). More VYC-15L-treated subjects had a 1-point reduction in EI-reported LFS score at month 3 versus untreated controls (84.7% vs 0%; p < 0.0001), and 65% of the treated subjects self-reported a 1-point LFS improvement at month 3. Procedural pain during injection was mild. The most common ISRs were swelling, tenderness to touch, and firmness. One treatment-related serious AE (injection site compression arterial ischemia) resolved in 16 days. Conclusion: VYC-15L treatment was superior to no treatment at 3 months and was well tolerated by subjects. Clinical Trial Registration Number: NCT03519204.

Juvéderm Volift (VYC-17.5L), a Hyaluronic Acid Filler with Lidocaine, is Safe and Effective for Correcting Nasolabial Folds in Chinese Subjects.

PURPOSE: Hyaluronic acid injectable gels are commonly used to treat nasolabial folds (NLFs). We evaluated the safety and effectiveness of VYC-17.5L for correcting NLFs in Chinese subjects. PATIENTS AND METHODS: This prospective, multicenter, double-blind, within-subject‒controlled study randomized adults with moderate-to-severe NLFs to VYC-17.5L treatment (initial and touch-up) in 1 NLF and control (without lidocaine) in the contralateral NLF. Effectiveness endpoints at 6 months included noninferiority of VYC-17.5L to control in NLF Severity Scale response rate (primary endpoint), subject-reported procedural pain (11-point scale), and investigator and subject assessments using the Global Aesthetic Improvement Scale (GAIS). RESULTS: A total of 175 subjects were included. The primary endpoint was met, with response rates of 84.2% for VYC-17.5L and 82.5% for control. Mean pain scores after initial and touch-up treatments were 2.4 for VYC-17.5L versus 5.2 for control (P < 0.001) and 2.0 versus 3.3 (P < 0.001), respectively. Investigator-rated GAIS scores were 86.5% for VYC-17.5L versus 86.0% for control. There were no between-group differences in subject-rated GAIS scores. Safety profiles were comparable for VYC-17.5L and control. CONCLUSION: VYC-17.5L was noninferior to control without lidocaine for correcting moderate-to-severe NLFs in Chinese subjects and was superior to control in reducing procedural pain.

Nanostructured Multiphase Condensation of Complex Coacervates in Polymerization-Induced Electrostatic Self-Assembly.

We present the nanostructured multiphase condensation of complex coacervates in the dynamic evolving aqueous medium of liquid-liquid phase separation driven polymerization-induced electrostatic self-assembly (LLPS-PIESA). We show that the parent droplets evolve into nanostructured coacervate-in-coacervate multiphase condensates with diverse morphologies, such as dandelions, worms, lamellae, vesicles, and vesicle polymers, upon the kinetically dictated recruitment of anionic free chains, cationic growing chains, and nascent clusters from the dynamic evolving aqueous medium of LLPS-PIESA, under the interplay of electrostatic and arginine-like salt bridge interactions.

Expert Consensus on Hyaluronic Acid Filler Facial Injection for Chinese Patients.

BACKGROUND: Beauty standards vary by race and region, which must be accounted for in creating beauty. Chinese have unique features, including a depressed nose, flat midface, and small chin, and have different cosmetic concerns. We performed a consensus study on filler injections based on the Chinese standard of beauty due to a lack of such study. METHODS: We organized the YVOIRE Consensus Group, including 5 plastic surgeons. We discussed common problematic areas seen in Chinese and described techniques based on our experience with hyaluronic acid fillers, while considering peer-reviewed articles, followed by multiple consensus-developing sessions. RESULTS: Chinese faces are characterized by retruded forehead, chin, and low nasal bridge, with certain features believed to bring good fortune. Therefore, profiles of the forehead, nose, lip, and chin have substantial effects on attractiveness. The demand for cosmetic procedures is high among the young generation who particularly desire nose and chin augmentation. Attractive Chinese facial shapes are characterized by a long, slender facial shape and pointed chin. Lips are narrow and thick. When injecting fillers for Chinese, it is necessary to apply special methods that produce results consistent with these characteristics. CONCLUSIONS: Understanding the concept and demand of beauty depending on race and region is important. Patients should be evaluated before aesthetic procedures. Maintaining hygiene during the procedure is crucial. Moreover, methods for preventing pain are essential. Fillers should be injected into the correct anatomical site and layer to minimize side effects and maximize effectiveness.

Rhinoplasty With Hyaluronic Acid: A Standard 5-step Injection Procedure Using Sharp Needle.

OBJECTIVE: To explore the clinical effect of rhinoplasty with a standard 5-step injection procedure of hyaluronic acid using sharp needle in correction of deficient features of the Chinese nose. METHODS: Between January 2016 and December 2018, hyaluronic acid was injected with the sharp needle by a standard procedure in the anterior nasal spine, nasal columella, nasal tip, nasal root, and dorsum, as well as the junction region of nasal root and brow in 198 Chinese patients. The postoperative curative effect was analyzed, and the adverse reactions were observed. RESULTS: The nasal shape in all patients was significantly improved, obtaining the stereoscopic appearance, and satisfactory results. During a 6-month follow-up, 4 patients developed local subcutaneous congestion and bruising in the nasal dorsum after treatment, which disappeared within 2 weeks. No patients suffered from complications such as infection, embolism, necrosis, transparent nasal dorsum, and widened nasal roots. CONCLUSIONS: Injection of hyaluronic acid with the sharp needle by a standard 5-step procedure is a safe technique that can effectively correct the deficient features of the Chinese nose.

Excision of sebaceous cyst by intraoral approach: A case report.

RATIONALE: Surgical removal of a sebaceous cyst is usually accomplished through an external incision, which inevitably results in a scar. Herein, we described an intraoral approach for excising sebaceous cysts located in the lip or cheek near lip commissure, to avoid a skin scar. PATIENT CONCERNS: Removal of the cyst but without leaving a scar on the face. DIAGNOSES: Six patients were diagnosed with a subcutaneous cyst located in the lip or cheek near lip commissure. INTERVENTIONS: We implemented an intraoral approach to excise the cyst, wherein an intraoral incision was made and blunt dissection was performed through the buccinator muscle or orbicularis oris muscle until the cyst wall was seen. The cyst was then dissected from the surrounding subcutaneous tissue by careful blunt dissection with a hemostat and completely removed through the intraoral incision. OUTCOMES: All patients had complete recovery, with no recurrence or complaints for at least 6 months after the surgery. LESSONS: A sebaceous cyst located in the lip or cheek near lip commissure can be excised by an intraoral approach through the mouth, which avoids a visible scar on the skin.

A modified reduction malarplasty utilizing 2 oblique osteotomies for prominent zygomatic body and arch.

The shape of the zygomatic body and arch have great influences to the facial contour of Orientals. The prominent zygoma makes the appearance look more fierce. Nowadays in China, the number of patients who underwent reduction malarplasty is increasing rapidly. Therefore, it is important to develop a reliable surgical procedure with small wound and good effects. Included in this report were 46 patients with prominent zygomatic body and arch treated between October 2007 and November 2010. Combined intraoral and extraoral approaches were used, and 2 oblique osteotomies were performed to anterior and posterior part of malar complex, respectively. The isolated zygoma segment was then internalized utilizing z-plasty for the posterior end and inward sliding and internal fixation for the anterior end. The extraoral approach was made through a small temple incision. All patients were subjectively satisfied with the postoperative appearance. Their face contours were effectively improved by the modified procedure. One patient had short-term numbness of the medial zygomatic region skin; no other complications were observed during the follow-up period. This surgical procedure was carried out using combined intraoral and extraoral approaches. No visible scars left on the face. After 2 oblique osteotomies were made, the anterior inward sliding and posterior z-plasty could be easily performed to the isolated zygomatic bone. No segmental bone removal was required. The natural curve of the face contour was maintained while the malar complex was reshaped. We concluded that it is an effective and safe reduction malarplasty technique for Orientals.

[Expression of inducible nitric oxide synthase in cartilage in progression of temporomandibular joint osteoarthritis].

OBJECTIVE: To study the expression of inducible nitric oxide synthase (iNOS) in cartilage of temporomandibular joint osteoarthriti (TMJOA), and to evaluate the role of iNOS in the progression of TMJOA. METHODS: The goats were used and TMJOA was induced by injection of collagenase in upper joint space. The joints were obtained and were investigated by using immunohistochemistry at 2, 4, 12, 24 weeks after injection. RESULTS: Almost no expression of iNOS in normal cartilage of TMJ. In the diseased joints, strong or definite iNOS reactivity was expressed. CONCLUSION: iNOS plays an important role in the progression of TMJOA.

[Recombinant human BMP-2 accelerates bone formation of mandibular distraction osteogenesis in rabbits].

OBJECTIVE: To study the effects of rhBMP-2 on bone formation of mandibular distraction osteogenesis in rabbits. METHODS: Bilateral mandibular osteotomies were performed in 12 mature rabbits. 5 mg rhBMP-2 with the collagen carrier was implanted in the osteotomy site of one side of the mandibles. Only the collagen sponge was placed in the contra-lateral side as control. The mandibles of 8 rabbits were lengthened by 6mm using a custom-made distractor. At 4 weeks after the end of distraction, all animals were killed and the distracted calluses were harvested and processed for histological, scanning electron microscopic, as well as Ca/P ratio analysis. RESULTS: The regenerated bone was found in the distraction gap after mandibular lengthening. The mandibular side treated with rhBMP-2 had greater amounts of new bone formation and earlier mineralization than contra-lateral side (non-rhBMP-2 treated). CONCLUSION: Recombinant human BMP-2 appears to be able to accelerate bone formation of mandibular distraction osteogenesis in rabbits.

[Expression of vascular endothelial growth factor during mandibular distraction osteogenesis in rabbits].

OBJECTIVE: To investigate the expression pattern of vascular endothelial growth factor (VEGF) in the distracted callus during mandibular osteodistraction. METHODS: Bilateral mandibular osteotomies were performed in 12 rabbits. 3 rabbits were sacrificed respectively at 0, 7, 14 and 28 days after completion of distraction. The newly formed calluses were harvested and processed for histology and immunohistochemistry of VEGF. RESULTS: Intense angiogenesis was observed in the regenerated callus after mandibular lengthening, and positive staining for VEGF was mainly noted in vascular endothelial cells and the active osteoblasts. CONCLUSIONS: Mechanical strain created by distraction led to angiogenesis in distraction gap. VEGF may play a critical role in angiogenesis and subsequent osteogenesis during mandibular lengthening.

Temporospatial expression of vascular endothelial growth factor and basic fibroblast growth factor during mandibular distraction osteogenesis.

OBJECTIVE: Distraction osteogenesis is a vascular-dependent process. This study investigated expression patterns of two major angiogenic factors, vascular endothelial growth factor (VEGF) and basic fibroblast growth factor (bFGF), in the distracted calluses following mandibular lengthening in a goat model. MATERIAL AND METHODS: Bilateral mandibular osteotomies were performed in 15 young adult goats. After a latency of 7 days, the mandibles were elongated using custom-made distractors with a rate of 1 mm/day for 10 days. Three animals each were sacrificed at the end of the delay phase, at 0, 7, 14, and 28 days after completion of distraction, respectively. The lengthened mandibles were harvested and processed for histological and immunohistochemical examinations. RESULTS: Elevated cellular expression of VEGF and bFGF, with neovascularization in the distraction gap, was observed following mandibular lengthening. VEGF staining was noted in the endothelial cells and osteoblasts. bFGF staining was seen in the fibroblast-like cells, osteoblasts and immature osteocytes. Their strongest expression was found 0-7 days after the end of distraction, and declined with maturation of the newly formed bone. CONCLUSION: A temporal and spatial expression pattern of VEGF and bFGF was found during distraction osteogenesis in goat mandibles. It suggests that distraction forces can stimulate the production of VEGF and bFGF, which contribute to neovascularization and new bone formation during gradual distraction of the mandible. Application of angiogenic factors may be considered as a potential method to enhance angiogenesis and osteogenesis in osteodistraction, especially in sites without enough vascularization.

[The effects of L-NMMA on experimental temporomandibular joint osteoarthrosis in goats].

OBJECTIVE: To investigate the effects of repeated injections of L-NMMA on a goat model with osteoarthrotic temporomandibular joint (TMJ) disease. METHODS: Eight goats were selected in this study. Bilateral TMJ osteoarthrosis (OA) was induced by injecting 0.5% collagenase. L-NMMA was injected into one side of TMJs at 4 weeks after collagenase injection (one time every three days). Another joint as control was simultaneously injected using 0.9% saline solution. All goats were killed at 12 weeks after collagenase injection. The TMJ specimens were harvested and processed for histological examination. Modified Mankin's grading score system was used for evaluating changes in the TMJ. RESULTS: The control side of TMJs showed severe osteoarhrotic changes in the condyle whereas the L-NMMA-treated TMJs showed less degenerative alterations. The histologic score was 3.83 in the L-NMMA treated side, and 6.33 in the control. There was a significant difference in osteoarthrotic changes between the L-NMMA-treated and control TMJs (P < 0.01). CONCLUSIONS: Repeated intra-articular injection of L-NMMA into TMJ may play a role in inhibiting TMJOA progression.

Biomechanical properties of regenerated bone by mandibular distraction osteogenesis.

OBJECTIVE: To study the biomechanical properties of the new bone generated by mandibular distraction osteogenesis (DO). METHODS: A total of 11 healthy adult goats were randomly divided into 2 groups, the experimental group (n=9) and the control group (n=2). For the goats in the experimental group, the bilateral mandibles were gradually lengthened for 10 mm with distraction appliances. Three goats were sacrificed respectively at 2, 4 and 8 weeks after completion of distraction. Compressive, three-point bending and shearing tests were conducted on the standard regenerated bone samples and the whole unilateral mandibular specimens. For the goats in the cont rol group, no operation was made and the whole unilateral mandible was taken as the test specimen. RESULTS: The compressive strength and bending stiffness of the new bone reached the normal level at 4 and 8 weeks after completion of distraction, respectively. But the shearing strength remained significantly weaker than that of the controls at 8 weeks after distraction. CONCLUSIONS: The distraction appliance can be removed and the lengthened mandible should be exposed to adaptive functional exercise at 8 weeks after completion of distraction.