Wrinkle Severity Rating Scale Score Research Articles

Three-dimensional Stereoscopic Evaluation and Quantitative Gray Scale Assessment of the Nasolabial Fold and Its Application in Injection Therapy

With the growing demand for aesthetic enhancements, particularly filler injections for nasolabial folds (NLFs), there is a need for more objective and quantitative assessment methods beyond the traditional subjective scales like the Wrinkle Severity Rating Scale (WSRS). This study introduces a novel evaluation method combining 3-dimensional (3D) imaging and grayscale analysis to objectively assess NLF severity and treatment outcomes. A total of 100 healthy participants (86 females, 14 males; mean age 41.85±11.53 years) were assessed using WSRS scores and quantitative 3D measurements. The results demonstrated a significant positive correlation between WSRS scores and gray values (r=0.985, P < 0.05). Significant differences in gray values and 3D linear measurements were observed across WSRS score groups, with high intra-rater reliability confirmed by intraclass correlation coefficients. In addition, 54 patients (mean age 42.9±8.9 y) with moderate to severe NLFs received hyaluronic acid injections. One month post-treatment, WSRS scores significantly decreased (from 3.74±0.45 to 1.63±0.59, P < 0.05), and significant improvements were observed in several 3D measurements. The average gray value also decreased significantly (P < 0.05), indicating a reduction in wrinkle depth. These findings were supported by representative photos showing patient satisfaction and no severe complications. This study validates the use of 3D imaging and grayscale analysis as reliable tools for objectively assessing NLF severity and monitoring treatment efficacy, potentially improving the precision and reliability of aesthetic evaluations in clinical practice.

Clinical effect of botulinum toxin type A combined with autologous fat grafting in patients with nasolabial fold depression.

Nasolabial fold (NLF) depression can affect the facial appearance of patients to some extent and increase their psychological burdens. In recent years, autologous fat grafting (AFG) combined with botulinum toxin A (BTX-A) injection (AFG + BTX-A injection) has been gradually applied in the treatment of patients with NLF depression. Although studies have been conducted on the efficacy and safety of AFG + BTX-A injection in treating NLF depression, the experimental design, observational indicators, and sample enrollment criteria vary remarkably, making it difficult to draw convincing and consistent conclusions. Thus, further relevant research is warranted. To assess the esthetic improvement, efficacy, and safety of AFG + BTX-A injections in patients with NLF depression. This study included 60 patients with NLF depression who were treated in our hospital from February 2019 to April 2021. These patients were categorized into control (n = 30) and observation (n = 30) groups. The observation group received AFG + BTX-A injection, whereas the control group underwent AFG only. All patients were evaluated using the wrinkle severity rating scale (WSRS) and global aesthetic improvement scale. The compactness of facial contours, skin evaluation indexes, adverse reactions, and satisfaction of the two groups were evaluated 3 months postoperatively. The WSRS scores of the observation group at 1, 3, and 6 months postoperatively were lower than those of the control group (P < 0.05). Three months postoperatively, facial fine lines and pores showed obvious improvement and the skin index score was higher in the observation group than in the control group (P < 0.05). The compactness of facial contours was better in the observation group than in the control group (P < 0.05). In addition, no remarkable differences were noted in the incidence of postoperative adverse reactions such as facial stiffness, facial asymmetry, facial bruising, and facial concavity inequality (P > 0.05). AFG + BTX-A injection is a highly safe, cost-effective, effective, and long-lasting treatment for NLF depression with high esthetic value, which should be promoted in the future.

Efficacy and Safety of Hyaluronic Acid Fillers With or Without Lidocaine in the Treatment of Nasolabial Folds: An Updated Systematic Review and Meta-Analysis.

To update the evidence on the effectiveness and safety of hyaluronic acid gel combined with lidocaine for treating nasolabial folds. We searched electronic databases including PubMed, Embase, Cochrane Central Register of Controlled Trials, and Web of Science using subject headings and keywords associated with hyaluronic acid and lidocaine in the context of nasolabial folds. Inclusion criteria were met by randomized controlled trials (RCTs) comparing the efficacy and safety of hyaluronic acid gel with or without lidocaine. Outcomes measured included visual pain analog scale (VAS) scores, wrinkle severity scale scores, and adverse events. The quality of RCTs was evaluated using the Cochrane Randomized Controlled Trials Scale, which encompasses criteria such as randomization, allocation concealment, blinding, dropout, and withdrawal rates, and was assessed by two independent reviewers. No significant difference in overall wrinkle severity rating scale scores was observed between HA with lidocaine and HA without lidocaine [MD=0.08, 95% CI (-0.09, 0.24), P=0.36]. However, there was a significant reduction in pain scale scores (VAS) [SMD=-2.47, 95% CI (-4.15, -0.79), P=0.004]; no significant differences were noted in the ncidence of at least one adverse event [RR=0.97, 95% CI (0.90, 1.05), P=0.51]; and there were no significant differences in swelling [RR= 0.99, 95% CI (0.92, 1.06), P=0.80], erythema [RR=1.01, 95% CI (0.91, 1.11), P=0.91], bruising [RR=0.99, 95% CI (0.89, 1.13), P=0.86], itching [RR=1.03, the 95% CI (0.88, 1.21), P=0.74], induration [RR=1.04, 95% CI (0.92, 1.17), P=0.55], and papules [RR=0.77, 95% CI (0.58, 1.02), P=0.07]. There was a significantly lower incidence of tenderness [RR=0.91, 95% CI (0.86, 0.97), P=0.002] only in the control group. Sensitivity analysis confirmed the stability of results across all outcome indicators with low sensitivity and high confidence. Subgroup analysis indicated higher wrinkle severity scores among East Asians compared to Europeans and Americans. HA containing lidocaine significantly reduces pain and is comparable in effectiveness and safety of HA without lidocaine. The clinical effects appear more pronounced in East Asians. Due to the limited number of related studies, further research is necessary. 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 .

Evaluation of Collagen Dermal Filler with Lidocaine for the Correction of Nasolabial Folds: A Randomized, Double-Blind, Multicenter Clinical Trial.

Porcine-based dermal injectable collagen is effective for nasolabial fold correction. In the present study, a new dermal injectable collagen, incorporating a novel cross-linking technology and premixed with lidocaine, was introduced. The study aimed to determine the efficacy of the new dermal injectable collagen in improving bilateral nasolabial fold wrinkles, and reducing pain during injection. This prospective, double-blind, multicenter, parallel-group, randomized trial enrolled participants with moderate-to-severe bilateral nasolabial fold wrinkles from February 2019 to March 2021. Participants were randomly assigned to the test group (new dermal injectable collagen with lidocaine featuring a novel cross-linking technology) or control group (traditionally cross-linked dermal injectable collagen with lidocaine). Participants were monitored for adverse events (AEs), and for pain using the Thermometer Pain Scale (TPS) and a visual analog scale (VAS). Efficacy was measured using the Wrinkle Severity Rating Scale (WSRS) and the Global Aesthetic Improvement Scale (GAIS). On the poor or better sides, the 2 groups exhibited a significant decrease in WSRS scores at 4, 12, 24, and 36 weeks after treatment, compared to baseline WSRS scores (all, p < 0.05). Compared to the control group, the test group had a greater decrease in WSRS score (poor or better sides) at 12, 24, 36, and 52 weeks after treatment (all, p < 0.05). A similar observation was also found in the WSRS response rate and GAIS score of the 2 groups. VAS and TPS scores were not significantly different between the 2 groups (p > 0.05), indicating that pain reduction was similar in the 2 groups. All AEs were anticipated AEs associated with facial aesthetic injections, and most recovered within 0 to 30 days without sequelae. There were no differences in AEs between the 2 groups (all, p > 0.05). The new dermal injectable collagen with lidocaine exhibited better efficacy for correcting nasolabial fold wrinkles compared to the control group. Both relieved pain and produced only transient and tolerable AEs.

A Prospective, Randomized, Double-Blind, Split-Face, Comparative Study to Evaluate the Efficacy and Safety of DKL23 and Juvéderm Volift for Correcting Moderate-to-Severe Nasolabial Folds.

Hyaluronic acid dermal fillers are used for multiple indications, including wrinkle correction and restoration of volume/fullness. The aim of this study was to compare the efficacy and safety of 2 hyaluronic acid products for correcting moderate to severe nasolabial folds (NLFs). A prospective, randomized, double-blind, split-face study was undertaken. The subjects' left and right NLFs were randomly allocated for treatment with DKL23 or Juvéderm Volift. Follow-up was conducted at 1, 3, 6, and 9 months. The changes from baseline on the Wrinkle Severity Rating Scale and the Global Aesthetics Improvement Scale were evaluated. Posttreatment adverse events (AEs) were recorded. Forty-eight women (median age, 57.0 years) with Type I to VI skin were enrolled. Both treatments showed statistically significant improvement (P < .0001) in NLFs according to the Wrinkle Severity Rating Scale score from baseline to each of the time points assessed. The improvement in NLFs was maintained until the end of the study (9 months). Furthermore, the change from baseline to each of the time points assessed was similar between DKL23 and Juvéderm Volift. Investigator- and subject-rated Global Aesthetics Improvement Scale scores showed similar rates of improvement (indicated by the sum of responses of improved, much improved, or very much improved) between the 2 products. The AEs reported in the study were in line with previous and expected experience after injection of hyaluronic acid dermal fillers. The types of AEs, their rates, intensity, and duration were comparable between the 2 products. DKL23 improved NLF severity from baseline and for up to 9 months, and the results were comparable to the improvement shown by Juvéderm Volift. Treatment was safe and well tolerated.

Efficacy and Safety of Fillers for the Treatment of Nasolabial Folds: A Network meta-Analysis of Randomized Controlled Trials.

Nasolabial fold formation is increasingly becoming a cause of concern for many people. However, no network meta-analysis has compared the efficacy of different fillers in treating nasolabial folds. This network meta-analysis simultaneously compared the efficacy and safety of various fillers. We included randomized controlled trials (RCTs) that used fillers to treat nasolabial folds. We extracted data of Wrinkle Severity Rating Scale (WSRS), Global Esthetic Improvement Scale (GAIS, investigator) scores, GAIS scores (self-reported) and adverse events. We included 13 RCTs. WSRS scores at 6 months were higher in patients receiving HA than those receiving poly (L-lactic acid) (mean difference [MD] 0.630, 95% confidence interval [CI] 0.275, 0.985) but significantly lower in patients receiving HA than in those receiving bovine collagen (MD - 0.580, 95% CI - 0.777, - 0.383) and porcine collagen (MD - 0.525, 95% CI - 0.790, - 0.260). Regarding adverse events, HA was significantly less likely to cause nodule formation compared with bovine collagen (RR 0.593, 95% CI 0.438, 0.803). HA is a safe filler for correcting nasolabial folds, and poly (L-lactic acid) showed potential in treating nasolabial folds. 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 .

Efficacy and Safety of Type III Collagen Lyophilized Fibers Using Mid-to-Deep Dermal Facial Injections for the Correction of Dynamic Facial Wrinkles.

This study aimed to evaluate the therapeutic efficacy and safety of injecting Type III collagen lyophilized fibers into the mid-to-deep layers of the facial dermis to ameliorate dynamic facial wrinkles. In this retrospective analysis, clinical data were collected from patients exhibiting dynamic facial wrinkles (encompassing frown lines, forehead lines, and crow's feet) with a wrinkle severity rating scale (WSRS) score of 3 or higher. In the control group, 75 participants received collagen implant injections into the mid-to-deep facial dermal layers, whereas 76 participants in the experimental group received injections of Type III collagen lyophilized fibers in similar layers. The study analyzed and compared clinical efficacy, WSRS score alterations, patient satisfaction, and safety profiles between the groups over the 30-day and 90-day treatment periods. At the 30-day mark, the therapeutic efficacy was not significantly different between the two groups (P>0.05). However, at 90 days, the treatment efficacy in the experimental group surpassed that in the control group, showing a statistically significant difference (P<0.05). After 30 days of treatment, the WSRS score improvement in the experimental group was significantly superior to that in the control group (P<0.05). Conversely, at the 90-day mark, the results revealed no significant variation in WSRS score improvements between the two groups (P>0.05). Regarding treatment satisfaction among researchers and participants post-30 and 90-day treatment in both groups, no statistically significant differences were observed (P>0.05). Similarly, the incidence of adverse reactions between the groups was not statistically significant (P>0.05). Injections of lyophilized type III collagen fibers into the mid-to-deep layers of the facial dermis have a definitive therapeutic effect on dynamic facial wrinkles. This treatment not only substantially diminishes wrinkle severity but also has a commendable safety profile. 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 .

Comparison of the efficacy and safety between a new monophasic hyaluronic acid filler and a biphasic hyaluronic acid filler in correcting facial wrinkles

Background The longstanding and common use of hyaluronic acid (HA) has driven the expanded development of various commercial HA fillers. However, differences in the components of these HA fillers lead to variations in their effect. We compared the &lt;i&gt;in vivo&lt;/i&gt; safety and efficacy of biphasic HA (BHA) and a new monophasic HA (MHA) for improving facial wrinkles. We investigated differences in outcomes after their injection into nasolabial folds (NLFs) using the Wrinkle Severity Rating Scale (WSRS), patient satisfaction using the Global Aesthetic Improvement Scale (GAIS), and pain using a visual analog scale (VAS). We also performed a safety assessment of the two fillers.Methods This matched-pair, double-blind, randomized study compared the degree of temporal wrinkle improvement in the NLFs of 91 participants using the BHA filler versus the new MHA filler. Safety and efficacy were compared at 8 and 24 weeks.Results At 24 weeks after application, the average WSRS scores were 2.17±0.72 (BHA) and 2.07±0.71 (MHA) (P=0.034). The average GAIS scores, as measured by a treating investigator at 8 weeks and 24 weeks, were 0.94±0.76 (BHA) and 0.98±0.78 (MHA) at 8 weeks (P=0.181), and 0.44±0.64 (BHA) and 0.49±0.69 (MHA) at 24 weeks (P=0.103). The VAS pain score was 0 points at 30 minutes after filler application in both groups.Conclusions Both the BHA filler and the new MHA filler were safe and effective for improving facial wrinkles in NLFs, but the new MHA filler was more effective for the cosmetic improvement of wrinkle severity than the BHA filler.

Modified Deep-Plane Face Lift and Lower Midface Lifting Using Deep Fat Compartment Mobilization and Zygomaticus Major Muscle Plication.

Most face-lift techniques greatly improve the lower face; however, techniques for lifting the midface are limited and difficult. Original deep-plane face lift is a way to lift the superficial musculoaponeurotic system and skin as a compound unit. Although it minimizes tear of the superficial musculoaponeurotic system during dissection, damage to the vascular system, and the incidence of skin necrosis, and can be easily used in secondary cases, the deep-plane face lift does not adequately improve nasolabial fold. The authors perform a modified and enhanced deep-plane face lift to improve the midface. In this article, the authors explain the effects and procedures of the method. This retrospective study included patients ( n = 632) on whom deep-plane face lift (DPF group; n = 299) and modified deep-plane face lift (M-DPF group; n = 333) was performed by a single surgeon from January of 2014 to January of 2017, and from February of 2017 to December of 2020, respectively, at a local clinic. The degree of improvement in wrinkles in the patients' nasolabial fold was assessed using the five-grade Wrinkle Severity Rating Scale (WSRS). The preoperative WSRS score was 2.95 ± 0.89 in the DPF group and 2.89 ± 0.92 in the M-DPF group. There was no significant difference in the preoperative WSRS score between the two groups ( P = 0.058). The postoperative WSRS score was 1.81 ± 0.68 in the DPF group, which was significantly greater than the 1.65 ± 0.66 found in the M-DPF group. This method developed by the authors that combines deep-plane face lift with deep fat compartment mobilization and zygomaticus major muscle plication is safe and directly improves the nasolabial fold and promotes a smiling expression for rejuvenation effects. Therapeutic, III.

Efficacy and Safety of Resilient Hyaluronic Acid Fillers Injected with a Cannula: A Randomized, Evaluator-Blinded, Split-Face Controlled Study.

Cannulas are increasingly used for injecting hyaluronic acid fillers, as they are thought to improve patient comfort safety and treatment tolerability. This study aimed to demonstrate the non-inferiority of a Resilient Hyaluronic Acid 4 (RHA 4) filler injected with a cannula versus a needle for the treatment of moderate to severe nasolabial folds (NLF). A total of 50 subjects were included in a randomized, evaluator-blinded, split-face trial. The NLF were injected with RHA 4 using a cannula on one side of the face and using a needle on the other side on Day 0. A touch-up could be performed 4 weeks later. The subjects were followed up for 12 weeks after the last injection, ie, injection on Day 0 or touch-up. Efficacy was evaluated using a Wrinkle Severity Rating Scale (WSRS), the Global Aesthetic Improvement Scale (GAIS), and patient-reported outcomes. Safety assessments included the injection-site pain, common treatment reactions (CTRs), and adverse events (AEs). Twelve weeks after the last injection, the efficacy of the cannula treatment was found to be non-inferior to that of the needle treatment, based on the WSRS score improvements. The other study endpoints showed the equivalent efficacy and safety of the two methods. No serious or unexpected AEs were reported. RHA 4 may be effectively and safely injected into the NLF using a cannula or a needle, provided it is administrated by a trained practitioner.

Patient-Specific Implants for Correction of Midfacial Aging.

The nasolabial folds (NLFs) may be shallowed with the use of nostril base augmentation. This study aimed to design and customize patient-specific implants (PSIs) with computer-aided design/computer-aided manufacturing (CAD/CAM) to correct NLF deepening caused by midfacial aging. The patient's head computed tomography data obtained and were used for reconstruction. The PSIs were customized by CAD/CAM techniques, which were implanted into a nasal base for shallow NLFs caused by midfacial aging. Preoperative and postoperative photos and a wrinkle severity rating scale were used to evaluate the changes in NLFs. Also, the global esthetic improvement scale was used to investigate the surgical satisfaction of patients. Eleven patients (22 NLFs) received PSIs in the nasal base (22 implants). The customized PSI matched well with premaxilla, reducing the difficulty of operation. After 3 to 12 months of follow-up, PSI was stable without foreign body reaction or inflammatory reaction. Postoperative wrinkle severity rating scale scores showed that NLF severity was reduced in all patients, with a significant esthetic improvement compared with preoperatively ( P < 0.01). The global esthetic improvement scale showed an extremely satisfied improved NLF in 27.27% of patients, much improved in 63.63%, and improved in 9.90% (2/22), and none reported change or poor NLF. Patient satisfaction with their midface appearance differed significantly before and after surgery ( P < 0.01). Individualized PSI designed with high precision and matching degree by CAD and prepared using CAM could be applied to overcome the limitations of noncustomized implants.

A Two-Center, Prospective, Randomized Controlled Trial to Evaluate the Efficacy and Safety of and Satisfaction with Different Methods of ART FILLER® UNIVERSAL Injection for Correcting Moderate to Severe Nasolabial Folds in Chinese Individuals.

Hyaluronic acid is the most popular dermal filler in the treatment of nasolabial folds. Injection methods vary among physicians. A randomized, two-center, double-blind, intraindividual trial was designed to compare a new method of injecting ART FILLER® UNIVERSAL using the retaining ligament with the traditional method (linear threading and bolus injection) in moderate to severe nasolabial folds. Forty patients with moderate to severe nasolabial folds were randomized into groups A and B. Group A received injections via the traditional method on the left side and the ligament method on the right side, while group B received the reverse. Clinical efficacy and patient safety were independently assessed by a blinded evaluator, the injector, using the Wrinkle Severity Rating Scale (WSRS), the Global Aesthetic Improvement Scale (GAIS), and the Medicis Midface Volume Scale (MMVS) at 4 weeks (before and after the touch-up injection), 8 weeks, 12 weeks, and 24 weeks after the baseline injection. From the perspective of the blinded evaluator, the improvements in WSRS scores from baseline did not differ significantly between the ligament method (0.73 ± 0.61) and the traditional method (0.89 ± 0.61) at week 24 (p > 0.05). The mean GAIS score at week 24 was 1.41 ± 0.49 for the traditional method and 1.32 ± 0.47 for the ligament method (p > 0.05). The efficacy and safety of the ligament method for the management of nasolabial folds are comparable to those of the traditional method in terms of WSRS and GAIS score improvement in the long run. The ligament method is superior to the traditional method in that it improves midface deficits with fewer adverse events. 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 . This study was registered with the Chinese Clinical Trial Registry under the registration number ChiCTR2100041702.

Botulinum toxin injection as a single or combined treatment with non-cross-linked high molecular weight and low molecular weight hyaluronic acid gel for neck rejuvenation: A randomized clinical trial.

The unpleasant appearance of the neck through the aging process could burden the psychosocial quality of life, therefore various treatment modalities have been used to rejuvenate the neck. The present study aimed to evaluate the efficacy of botulinum toxin injection as a single or combined treatment with Profhilo gel for neck rejuvenation. Patients with a request for neck rejuvenation meeting the inclusion criteria were randomly divided into two groups. Initial clinical scoring based on Wrinkle Severity Rating Scale (WSRS) and skin biomechanical parameters using a multiadaptor system (MPA) were performed before starting the treatment. Dysport Botox was injected for all of the participants, moreover, in one of the groups (intervention), Profhilo gel was injected after 2 weeks and a follow-up visit was performed for both groups 3 months later. Patients were evaluated according to the GAIS (global aesthetic improvement scale) by two blind dermatologists and skin biophysical parameters were measured by MPA such as TEWL, hydration, thickness, density, visco-elasticity, net elasticity, pliability/firmness. In this study, 19 participants in the control (Dysport) and intervention (Dysport + PROFhilo gel) groups were evaluated. Before starting the treatment, the two groups were similar in terms of WSRS scores and biophysical skin parameters. Three months after the treatment, it was observed that Hydration (p< 0.001) and Thickness of the skin (p= 0.028) in the intervention group were significantly higher than in the control group. Similarly, the GAIS scores of the intervention group showed significantly better results comparing to the control group (p< 0.001). Profhilo gel following Dysport Botox can be considered as a safe and more effective treatment of neck aging comparing to Dysport Botox injection alone in patients who are not a candidate for surgery due to any reason.

A randomized, participant- and evaluator-blinded, matched-pair prospective study to compare the safety and efficacy between polycaprolactone-based fillers in the correction of nasolabial folds.

Polycaprolactone (PCL)-based fillers are widely used for skin rejuvenation and wrinkle reduction. The objective of this study is to compare the efficacy and safety of newly developed PCL-based fillers (SYB filler®; SF-01) and widely used existing PCL-based fillers (Ellansé-M®) for correction of moderate-to-severe nasolabial folds. In a randomized, participant-and evaluator-blinded, matched-pair, prospective study, participants were randomized for injections of SF-01 or Ellansé-M® in both nasolabial folds. Efficacy was evaluated using the Wrinkle Severity Rating Scale (WSRS), Global Esthetic Improvement Scale (GAIS), and a three-dimensional (3D) scanner. All adverse events (AEs) were examined and reported. At month 12, both SF-01-and Ellansé-M®-treated groups showed statistically significant improvements in the WSRS, GAIS, and 3D scanner scores compared to baseline. The difference in changes in WSRS scores at month 12 between the two groups was 0.08 ± 0.34 compared to baseline. The upper limit of the 95.0% confidence interval was 0.0031, which was lower than the predefined margin for non-inferiority (0.35). All AEs were injection site-related (swelling, pain, and erythema) and disappeared within 30 min after the procedure. SF-01 was non-inferior to Ellansé-M® and demonstrated favorable efficacy and safety at 12 months after correcting moderate-to-severe nasolabial folds.

The selection of hyaluronic acid when treating with the nasolabial fold: A meta-analysis.

Hyaluronic acid (HA) gel is a widely used dermal filler for the correction of facial volume loss. The relationship between the characteristics of HA and clinical efficacy remains unclear. The aim of this systematic review and meta-analysis was to compare the efficacy and safety of monophasic and biphasic HA in the treatment of nasolabial folds (NLFs). Studies were identified by searching the electronic databases PubMed, Embase, and Web of Science from inception to May 2021. Randomized controlled trials (RCTs) were selected according to the inclusion criteria. Outcomes included the Wrinkle Severity Rating Scale (WSRS) score, Global Aesthetic Improvement Scale score, and incidence of adverse events. A total of 1190 patients from 14 RCTs were included in the meta-analysis. The mean WSRS score improvement in the biphasic HA group was much lower than that in the monophasic HA group (MD=0.18, 95% CI: 0.16-0.20, p<0.00001). The subject satisfaction percentage was significantly higher for monophasic than biphasic HA (RR=1.95, 95% CI: 1.09-3.48, p=0.02). There was no significant difference in the adverse event rate between the monophasic and biphasic HA groups (RR=0.96, 95% CI: 0.75-1.24, p=0.77). Regardless of whether improvement in NLFs or patient satisfaction is considered, monophasic HA is better than biphasic HA. Regarding the adverse event rate, there is no difference between monophasic and biphasic HA.

Quantitative Evaluation of Nasolabial Fold by Three-Dimensional Imaging: A Comparison with WSRS Score.

Nasolabial fold (NLF) reveals the aging of the face, and various treatments for NLF have been developed currently. However, most methods introduced to evaluate NLF are subjective and qualitative. This study was aimed to establish and validate a quantitative evaluation method by three-dimensional imaging, and thus accordingly to determine the relationship between quantitative measurements and wrinkle severity rating scale (WSRS) score. Seventy-five Asian female volunteers were enrolled for evaluating the severity of NLF based on both WSRS score and three-dimensional imaging. Three-dimensional imaging was used to collect the quantitative measurements of NLF, including length, width, and depth. The relationship between multiple WSRS scores and quantitative measurements was compared statistically. Besides, thirty patients with moderate or severe NLF were admitted to receive hyaluronic acid injection for NLF correction. All NLFs were evaluated quantitatively pre-injection and 3 months post-injection. The results revealed a statistically significant positive relationship between the WSRS score and the length, width, and depth of NLF, respectively. After 3 months of hyaluronic acid injection, the mean WSRS score, the length, width, and depth of NLF were significantly reduced. Three-dimensional imaging can be used to quantitatively assess the severity of the nasolabial folds, compensating for the deficiencies of traditional scales. This technique may help improve rejuvenation procedures for the aging nasolabial fold. 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 .

Efficacy and safety of two hyaluronic acid fillers withdifferent injection depths for the correction of moderate-to-severe nasolabial folds: A 52-week, prospective, randomized, double-blinded study in a Chinese population.

Hyaluronic acid (HA) fillers are known to be effective for the correction of facial wrinkles and folds, but there is no clinical study that compares the efficacy of small-to-medium-particle HA fillers and large-particle HA fillers for the correction of nasolabial folds (NLFs). Moreover, injection depth also plays an important role in the correction of NLFs as well as improvement of facial aesthetics. To assess the efficacy, safety, and durability of a small-to-medium-particle HA filler, Restylane, and a large-particle HA filler, Yishumei, as well as the effect of injection depth in the correction of moderate-to-severe NLFs and facial aesthetics in a Chinese population. This 52-week, prospective, randomized, double-blind study enrolled 100 participants with moderate-to-severe NLFs. The participants were randomized to receive either Restylane (Group A) or Yishumei (Group B). Group A and Group B were further randomly divided into a superficial injection group (Group A1 & B1) and a deep injection group (Group A2&B2) according to injection depth. Improvement in the Wrinkle Severity Rating Scale (WSRS) score and Global Aesthetic Improvement Scale (GAIS) and participants' satisfaction were evaluated as endpoints. All adverse events were monitored throughout the study. The treatments were well tolerated by all the participants. All four groups showed a reduction in their mean WSRS scores and GAIS scores by week 12. At week 24, the WSRS and GAIS scores did not change in Group A1 and A2, while participants in Group B1 and Group B2had higher WSRS and GAIS scores than those in the previous weeks. By week 52, the WSRS scores in all the groups returned to almost baseline levels. The mean FACE-Q scores increased compared with the baseline scores in all groups through week 24. Most participants were satisfied with their treatment, and no meaningful differences were found between the fillers in terms of participant satisfaction. The most common adverse events were swelling, redness, and tenderness at the injection site, but they resolved spontaneously without treatment. The two HA fillers had good therapeutic effect on NLFs in the early stage of treatment, but Restylane had a more prolonged effect. Moreover, compared with the superficial injection, the deep injection provided slight midface lifting and improved facial aesthetics.

Monophasic versus biphasic hyaluronic acid filler for correcting nasolabial folds: a systematic review and meta-analysis.

Hyaluronic acid (HA) fillers are the most popular dermal fillers for wrinkle correction and facial rejuvenation. Recently, there has been an interest toward classifying HA fillers based on the cross-linking properties into monophasic (MHA) and biphasic (BHA) fillers. We aimed to compare the efficacy and safety outcomes between MHA and BHA fillers for the correction of nasolabial folds (NLFs). We searched Medline, Embase, and CENTRAL for randomized controlled trials (RCTs) that compared MHA filler to BHA filler for individuals with moderate-to-severe bilateral NLFs. We sought to evaluate the following outcomes: Wrinkle severity rating scale (WSRS), pain on visual analog scale (VAS), global aesthetic improvement scale (GAIS), and adverse events. The standardized mean difference (SMD) was used to represent continuous outcomes while risk ratio (RR) was used to represent dichotomous outcomes. A total of 11 RCTs that enrolled 935 participants deemed eligible. MHA filler revealed a significant improvement in the overall WSRS score and GAIS score compared to BHA filler (SMD=-0.38, 95% CI -0.49 to -0.27 and SMD=0.34, 95% CI 0.24-0.45, respectively). No significant difference was noted between MHA and BHA fillers in terms of pain score or adverse events (SMD=-0.39, 95% CI -0.81-0.03 and RR=1.00, 95% CI 0.89-1.12, respectively). MHA filler showed discernable cosmetic results and comparable effective and tolerability to BHA filler.

Efficacy and safety of a new hyaluronic acid filler for nasolabial folds: A 52-week, multicenter, randomized, evaluator/subject-blind, split-face study.

Hyaluronic acid fillers are known to be effective for correction of nasolabial folds. Recently, a novel biphasic hyaluronic acid filler incorporating lidocaine, DIVAVIVA medium has been introduced. We compared the efficacy and safety between DIVAVIVA medium and Restylane Perlane Lidocaine for moderate to severe nasolabial folds. This was a multicenter, randomized, evaluator/subject-blind, active-controlled, split-face study. A study 1 evaluated the efficacy and safety until 24weeks. Extension study, study 2, included subjects who wanted to enroll and evaluated the efficacy and safety until 52weeks. The Wrinkle Severity Rating Scale (WSRS) score, Global Aesthetic Improvement Scale, and Visual Analogue Scale measuring pain were evaluated. All adverse events were monitored. The mean change of WSRS at week 24 was -0.61±0.54 in DIVAVIVA medium group and -0.59±0.49 in Restylane Perlane Lidocaine group. The difference between two groups was 0.08, which was lower than noninferior limit. In study 2, the mean change of WSRS score at week 52 from baseline was -0.01±0.62 in DIVAVIVA group, 0.06±0.57 in Restylane Perlane Lidocaine group. The primary and secondary efficacy outcomes were also achieved in study 1 and 2. There was no significant difference in the incidence of adverse events between the two groups. DIVAVIVA medium has comparable efficacy and safety with Restylane Perlane Lidocaine for correction of moderate to severe nasolabial folds.

Two Randomized Controlled Trials of Hyaluronic Acid Fillers for the Correction of Nasolabial Folds.

These were split-face designed, evaluator-blind, noninferiority studies. Fifty-eight subjects with moderate-to-severe NLFs were enrolled in the first study and treated with YC and RES, and 57 subjects were enrolled in the second study and treated with YV and PER. The Wrinkle Severity Rating Scale ranged from 1 (no visible fold) to 5 (extremely deep and long folds), and subject satisfaction was evaluated. The least squares mean Wrinkle Severity Rating Scale scores (standard error) at week 26 were 2.56 (0.09) for both YC- and RES-treated NLFs and 2.89 (0.08) and 2.91 (0.08) for YV- and PER-treated NLFs, respectively. The difference between the groups was 0 and 0.02, and the lower limit of its 95% confidence interval was -0.0725 and -0.0125, which was greater than the predefined margin (-0.29), proving the noninferiority of YC and YV to RES and PER, respectively. The safety profiles and subject satisfaction of YC and YV were similar to those of RES and PER, respectively. YC is comparable to RES and YV is comparable to PER in terms of performance and safety profiles, with NLF-correcting effects lasting for up to 26 weeks.