An evaluation of the effectiveness of 'ULTRACOL 200' in enhancing nasolabial fold wrinkles through cutaneous repair.

BACKGROUND: Injectable filler, a nonsurgical beauty method, has gained popularity in rejuvenating sagging skin. In this study, polydioxanone (PDO) was utilized as the main component of the ULTRACOL200 filler that helps stimulate collagenesis and provide skin radiant effects. The study aimed to evaluate and compare the effectiveness of ULTRACOL200 with other commercialized products in visually improving dermatological problems. METHODS: Herein, 31 participants aged between 20 and 59 years were enrolled in the study. 1 mL of the testing product, as well as the quantity for the compared groups was injected into each participants face side individually. Subsequently, skin texture and sunken volume of skin were measured using ANTERA 3D CS imaging technology at three periods: before the application, 4 weeks after the initial application, and 4 weeks after the 2nd application of ULTRACOL200. RESULTS: The final results of skin texture and wrinkle volume evaluation consistently demonstrated significant enhancement. Consequently, subjective questionnaires were provided to the participants to evaluate the efficacy of the testing product, illustrating satisfactory responses after the twice applications. CONCLUSION: The investigation has contributed substantially to the comprehension of a PDO-based filler (ULTRACOL200) for skin enhancement and provided profound insight for future clinical trials.

Optimal Changes Seen in Patients After Treatment With Poly- l -Lactic Acid: A Retrospective Descriptive Study.

BACKGROUND: Poly- l -lactic acid (PLLA) is a biostimulator that enhances collagen production and leads to volume restoration. It became popular because of its improvement of facial wrinkles and long-lasting effect, although the specific visible changes it causes in the facial area are not fully described. OBJECTIVE: To identify and characterize the visible changes resulting from injecting PLLA into the facial area. METHODS: A list of 678 patients who underwent 2 to 3 treatments with PLLA injections in this center between 2021 and 2022 were retrieved. After 2 rounds of evaluations, 31 independent international evaluators described the 3 main changes they observed in the before-and-after images (taken approximately 7 months after the last injection session) of the 12 patients with the most significant improvement. RESULTS: A total of 1,015 descriptions were received. They were divided into categories based upon similarity. The main detected changes were better contouring and enhancement of the lateral face, a lifting effect and secondary impact on the nasolabial fold, and improvement of skin texture and skin firmness. CONCLUSION: Poly- l -lactic acid injections were judged to be effective for contouring, lifting, and improving skin texture in the facial area. Further research is needed to validate these results and create an assessment scale for PLLA injections.

Efficacy of a New Hyaluronic Acid Dermal Filler on Nasolabial Folds Correction: A Prospective, Comparative, Double-Blinded Clinical Trial.

BACKGROUND: Hyaluronic acid-based dermal fillers are the cornerstones of wrinkle correction and facial contour redefinition. OBJECTIVE: To assess the efficacy and safety of EST LF compared with RES L for the treatment of nasolabial folds (NLFs). MATERIALS AND METHODS: In this prospective, split-face, randomized, investigator and subject-blinded trial, 45 subjects with moderate-to-severe symmetrical NLFs were randomized to EST LF on one side of the face and RES L on the other side and were followed up for 9 months. The primary end point was change in WSRS score from the baseline to Month 1 (M1). Secondary end points included changes in WSRS score at other time points, aesthetic improvement, wrinkle volume quantification, adverse events, and local tolerance. RESULTS: The efficacy difference between EST LF and RES L at M1 was in favor of EST LF (-0.16, CI, -0.28 to -0.03]), demonstrating its noninferiority. Considering other time points, significant differences were observed at 3 and 6 months for EST LF , assessed with WSRS, GAIS, or NLF volume quantification. Both treatments were well tolerated. CONCLUSION: EST LF is effective and well tolerated for the treatment of NLFs.

Suture Net Technique for Mid-face Superficial Fat Compartments Restoration.

BACKGROUND: Facial fold and groove formation is influenced by the ptosis of the superficial fat compartments in the mid-face region. OBJECTIVE: This study aimed to design a facial rejuvenation technique that targets sagging of the mid-face fat compartments and achieves a youthful facial configuration. MATERIALS AND METHODS: A total of 102 patients underwent suture net restoration. Each specific ptosis fat compartment was carefully lifted and held at the regional facial ligaments to effectively restore volume distribution. Patient outcomes were evaluated through preoperative and postoperative photography comparison, 3-D photographic analysis, and postoperative evaluations. RESULTS: Significant mid-cheek rejuvenation was observed. The procedure resulted in a remarkable, 10.89% increase in malar projection. The nasolabial fold improved by at least 1 grade in 61.43% of the patients and by at least 2 grades in 37.14%. A total of 87.65% of the patients expressed high satisfaction or satisfaction with the outcomes of the procedure. CONCLUSION: By specifically targeting the mid-face ptosis fat compartments, the technique demonstrated significant enhancements of both the nasolabial fold and the malar projection. The results indicate that this novel technique holds promise as an efficient approach for satisfactorily addressing facial aging concerns.

Validating the Reliability and Clinical Relevance of a Nasolabial Fold Photonumeric Scale.

BACKGROUND: The use of tissue fillers to treat age-related deepening of the nasolabial fold (NLF) has increased and become the standard clinical approach, creating a need for evidence-based, objective evaluation for pre- and post-procedure assessment of the NLF. METHODS: A 5-point rating scale was developed to assess the NLF, specifically the presence of depression and shadowing. Live validation of the scale was performed with a total of 73 participants representing the full range of NLF severities. Physicians board-certified in a core aesthetic specialty (3 trained raters) performed the scale validation over 2 rounds, 2 weeks apart. Training was carried out, and test-retest reliability was quantitated through the determination of intra- and inter-rater reliability by percentage of agreement, weighted kappa statistic with 95% confidence interval (CI), and intraclass correlation coefficient with 95% CI. To evaluate the clinical relevance of a 1-grade difference, rater assessments of 90 photo pairs were compared with previous designations of clinically different or not clinically different. RESULTS: The NLF scale achieved near-perfect intra- and inter-rater reliability when utilized by trained raters to assess a diverse group of live participants. Furthermore, clinically relevant differences between grades were established, and a 1-point difference was detectable by trained evaluators using the NLF scale. CONCLUSION: The clinically relevant and highly reliable validated NLF scale provides a standardized grading system with a user-friendly design for objectively assessing NLF in clinical practice and as a research tool for clinical approval studies of new aesthetic products and technologies. J Drugs Dermatol. 2024;23(1):1284-1291.   doi:10.36849/JDD.7316.

Ultrasonographic Evaluation of Facial Artery in the Nasolabial Fold for Gender Differences and Symmetry Between Hemifaces.

OBJECTIVES: The aim of this study was to establish the relationship of facial artery with nasolabial fold by color Doppler sonography and to determine facial artery variations and their relationship with age, gender, or hemifaces. METHODS: The study included 188 patients (94 women, 94 men) aged 18-60 years. Overall, 376 facial arteries in both hemifaces were evaluated for the course within nasolabial fold, symmetry, and relationship with gender. RESULTS: The mean age of the patients was 39.29 ± 12.81 years. Type A (55.7%) was the most common type in both hemifaces. There was no significant relationship between the course of facial artery and age (P > .05). Asymmetrical course of facial artery was more common in females (54.3%). In both genders, type A was the type with highest symmetry detected. CONCLUSIONS: Nasolabial fold is one of the important facial regions for filler injection. To prevent vascular injection, course of facial artery should be identified within the nasolabial fold. Type A was the most common type in both hemifaces and genders. Although the rates were close to each other, asymmetry in the course of the facial artery was observed in most of the patients. Ultrasonographic examination which is non-invasive and non-ionizing imaging method can be performed carefully before filler injection to determine vascular tissues.

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.

The article titled "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," authored by Feng et al. in Aesthetic Plastic Surgery, aims to compare two hyaluronic acid (HA) injection techniques for enhancing nasolabial folds: the conventional injection method and the ligament injection method. However, concerns have arisen regarding the methodology employed in this study. Having a precise understanding of the properties of the active substance is crucial for treatment standardization. It is imperative to comprehensively grasp the key characteristics of the employed HAs to determine any potential correlation between these properties, outcomes, and the likelihood of complications. Understanding HA's rheological properties, including viscosity, elasticity, and cohesiveness, is essential for selecting the most appropriate facial filler. While recognizing the authors' contributions, we firmly believe that further analysis should encompass these factors.Level of Evidence V 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 .

Effectiveness and Safety of Resilient Hyaluronic Acid (RHA) Dermal Fillers for the Correction of Moderate-to-Severe Nasolabial Folds in People of Color: Post Hoc Subgroup Analyses of US Pivotal Clinical Data.

BACKGROUND: People of color (POC) are often underrepresented in clinical studies evaluating the safety and effectiveness of aesthetic products, including hyaluronic acid (HA) fillers, for which there is to date limited clinical data in POC. OBJECTIVES: The aim of this study was to assess the safety and effectiveness of a new line of dynamic resilient HA fillers (RHA; Revance, Nashville, TN) for treating moderate-to-severe nasolabial folds (NLFs) in POC vs non-POC. METHODS: Post hoc subgroup analyses compared the efficacy and safety of POC vs non-POC subjects treated with RHA2, RHA3, or RHA4 for correction of moderate-to-severe NLFs in the pooled per-protocol population (N = 217) in 2 clinical trials. Evaluated population cohorts were classified by Fitzpatrick skin type (FST) (high FST [IV-VI] vs low FST [I-III]) and by subject-reported race (non-White vs White) relative to baseline at 6, 9, 12, and 15 months. RESULTS: POC consistently showed greater improvement in wrinkle severity and higher responder rates compared with non-POC, which reached statistical significance at several measured time points. Global Aesthetic Improvement Scale scores and subject satisfaction ratings were similar for POC and non-POC and remained high throughout the course of the study. Treatment-related adverse event rates were generally lower for high FSTs vs low FSTs, with no reported cases of keloidal scarring. CONCLUSION: The RHA line of dynamic fillers is well tolerated and effective for the correction of moderate-to-severe NLFs in POC and can be confidently used in this important and growing patient population.See the abstract translated into Hindi, Portuguese, Korean, German, Italian, Arabic, Chinese, and Taiwanese online here: https://doi.org/10.1093/asj/sjad251.

Free Dermal Fat Grafting: A Novel Technique for the Correction of Nasolabial Folds During Facelift Surgery.

BACKGROUND: Traditional facelift surgery does not behave well in the correction of nasolabial folds, which is a common clinical problem and needed to be improved. OBJECTIVES: To investigate the effect of free dermal fat grafting during facelift surgery for the treatment of nasolabial folds. METHODS: This prospective cohort study involved 80 patients with moderate to severe nasolabial folds and facial skin dermatolysis. Fifty of them underwent facelift surgery combined with free dermal fat grafting, and 30 of them underwent traditional facelift surgery. These patients were followed up 2 months, 6 months, and 1 year after the surgery to evaluate the effect. RESULTS: The difference in Wrinkle Severity Rating Scale (WSRS) scores, assessed at each follow-up, between the patients who underwent and did not undergo free dermal fat grafting during facelift surgery, was statistically significant. For patients who underwent free dermal fat grafting during facelift surgery, the WSRS scores assessed at 2 months, 6 months, and 1 year after the surgery were significantly different from those before the surgery. The analytic results of FACE-Q indicated a high level of overall satisfaction rate. No major complications were recorded. CONCLUSIONS: Free dermal fat as a filler for nasolabial folds can achieve excellent therapeutic effect. The combination of facelift surgery with free dermal fat grafting for the treatment of nasolabial folds can provide very good long-term results and a high patient satisfaction rate for patients with symptoms of facial aging such as facial dermatolysis, obvious wrinkles, and deep nasolabial folds.

Ultrasonographic analysis of facial skin thickness in relation to age, site, sex, and body mass index.

BACKGROUND: Numerous nonsurgical but invasive cosmetic procedures are performed blindly in the dermis or subcutaneous fat layer of the facial skin. OBJECTIVES: To measure the numerical skin thickness of the facial areas where dermatological procedures are performed by applying ultrasound techniques, and to make it possible to estimate the skin thickness by investigating the influence of several individual constitutional factors such as age, sex, and body mass index (BMI), so that these variables can be applied to estimate skin thickness. MATERIALS AND METHODS: Skin thickness was measured at eight different facial points using an ultrasound machine (Affiniti 50; Philips Inc.). Demographic data were gathered using questionnaires. Manual BMI was calculated from the weight and height of each participant, and individual BMI measurements were performed using a body composition analyzer. RESULTS: In terms of whole skin thickness, the thickest point was the mouth corner, and the thinnest point was the lateral forehead. The thickest point in the epidermis was the chin, and the thinnest point was the nasolabial fold. The thickest point in the dermis was the corner of the mouth, and the thinnest was the lateral forehead. Full skin thickness and dermal thickness were mostly lower in females. Skin thickness was not significantly correlated with BMI. CONCLUSION: The skin thickness at different points on the face was variable, and realistic data about skin thickness can be obtained by in vivo ultrasonographic analysis of the skin.

Efficacy of radiofrequency combined with single-dot ultrasound efficacy for skin rejuvenation: A non-randomized split-face trial with blinded response evaluation.

BACKGROUND: High-intensity focused ultrasound (HIFU) and radiofrequency (RF) are non-invasive modalities for skin rejuvenation, but their combined effects have not been evaluated. OBJECTIVE: We evaluated and compared the efficacy of HIFU alone and combined HIFU and bipolar RF using a newly designed probe. METHODS: Twenty-two Korean adults with facial wrinkles and aging underwent treatment on both sides of their face: HIFU-only on the left and HIFU combined with RF on the right. Skin parameters were measured at different time points to evaluate the improvement in skin rejuvenation. RESULTS: HIFU treatment significantly improved skin parameters, including pore volume and number, skin elasticity, depth of eye wrinkles, degree of sagging in the eye area, nasolabial folds and cheeks, volume of the jawline, skin density, and permittivity. Furthermore, combining bipolar RF with HIFU treatment enhanced efficacy in reducing pore number, improving skin elasticity, diminishing eye wrinkle depth, and increasing skin moisturization. These findings indicate that bipolar RF can synergically improve skin rejuvenation by providing a thermal effect to the upper papillary dermis, which is more superficial than the target area of HIFU. CONCLUSION: Combining HIFU with bipolar RF synergistically improves skin rejuvenation, including pore reduction, periorbital wrinkle improvement, skin elasticity, and skin moisturization.

Efficacy evaluation of endolift laser for treatment of nasolabial folds and marionette lines.

BACKGROUND: The nasolabial folds are the most marked sign of aging. Endolift laser was used for the treatment of nasolabial folds and marionette lines (one of the facial danger zones). METHODS: Ten female subjects were engaged in this study. Patients underwent Endolift laser for nasolabial folds and marionette lines treatment. The efficacy of the Endolift technique on the nasolabial folds and marionette lines was evaluated by biometric assessment with Cutometer, Visioface, and the Skin Ultrasound Imaging system. Also, patient's satisfaction and blinded dermatologists' assessment were assessed. RESULTS: The Visoface results displayed that the Endolift laser treatment significantly declined the depth and area of the nasolabial wrinkles. The skin ultrasonography results reported that the epidermis and dermis density and thickness were significantly increased. Also, the cutometer outcomes showed that the Endolift laser treatment can increase skin elasticity. The results showed that a large number of patients were very satisfied with the technique. CONCLUSION: In conclusion, Endolift laser has an effective technique for decreasing the nasolabial folds, marionette lines, and improve the appearance of the face without any sever side effect. This technique does not need general anesthesia and recovery time.

Comparative analysis of original face and skin-warped average face images for the scoring of skin attributes.

OBJECTIVES: Representative of a panel, an average face image could be used to analyse/display skin changes while alleviating image rights constraints. Therefore, we used landmark-based deformation (warping) of individual skin images onto their panel's average face, evaluating this approach's relevance and possible limits. METHODS: An average front face image was constructed from images of 71 Japanese women (50-60 years old). After warping individual skin images onto this average face, the resulting skin-warped average faces were presented to three experts who graded: forehead wrinkles, nasolabial fold, wrinkle of the corner of the lips, pore visibility and skin pigmentation homogeneity. Two experts estimated subjects' age. Results were compared to gradings performed on original images. RESULTS: Inter-expert grading shows excellent to good correlation whatever image type: from 0.918 (forehead wrinkles) to 0.693 (visibility of pores). Correlations between scoring of both image types are almost always higher than inter-expert correlations (maximum: 0.939 for forehead wrinkles-minimum: 0.677 for pore visibility). Frequencies of grades/ages are similar when scoring original and skin-warped average face images. Experts scores are similar in 90.6%-99.3% of the cases. Average deviations upon scoring both image types are smaller than average inter-expert deviations on original images. CONCLUSIONS: Scoring facial characteristics in original images and skin-warped average face images show an excellent agreement, even for perceived age, a complex feature. This opens the possibility of using this approach to grade facial skin features, monitor changes over time, and to valorise results on a face deprived of image rights.

Evaluating Predictors of Patient Satisfaction With Facial Appearance After Mohs Micrographic Surgery Using the FACE-Q.

BACKGROUND: Although patient satisfaction with reconstructive outcomes after facial skin cancer resection is an important consideration in Mohs surgery, there is limited information evaluating this concern using validated patient-reported outcome tools. OBJECTIVE: To characterize predictors that may be associated with increased postoperative patient satisfaction with facial appearance after Mohs surgery using the FACE-Q/Skin Cancer survey, a patient-reported outcome tool that has been validated in various studies. METHODS: A total of 202 patients who underwent Mohs surgery for facial skin cancer at the Brigham and Women's Faulkner Hospital between April 2017 and November 2021 were included after completing the postoperative Satisfaction with Facial Appearance scale (FACE-Q scale). RESULTS: Male patients were significantly more likely to have higher satisfaction scores compared with female patients (aOR 2.4, 95% CI 1.1-5.1). Increased preoperative facial satisfaction scores was directly correlated with increased postoperative facial satisfaction scores ( p < .01). Patients with tumors on the lower face/neck (aOR 3.88; 95% CI 1.4-10.7) had significantly greater satisfaction scores compared with those with tumors on their nose/nasolabial folds. CONCLUSION: Potential interventions and counseling methods can be tailored toward specific patient populations with lower satisfaction scores to increase their overall satisfaction with reconstructive outcomes.

V-shaped Folded Nasolabial Flap in the Repair of the Anterior Buccal Mucosal Defect.

OBJECTIVE: To investigate the efficacy of V-shaped folded nasolabial flap in the repair of small-sized and medium-sized defects of the anterior buccal mucosa. METHODS: From March 2019 to December 2021, 9 cases of male patients with anterior buccal mucosal lesions were enrolled in this study. After the lesions were completely excised, the mucosa and part of the buccal mucosal defect were left. A transverse V-shaped folded nasolabial flap was created with the pedicle located at the corner of the mouth and the long axis along the nasolabial fold. The lower part was lifted from the end to the pedicle. Next, from the level of the superficial musculo-aponeurotic system, the upper and lower parts were lifted from the end to the pedicle, and the V-shaped flap was folded and turned over through the buccal tunnel to repair the mucosal defect. The extraoral donor site was directly pulled and sutured. RESULTS: The nasolabial flap survived in 9 patients, and the wounds inside and outside the mouth healed at stage I. The postoperative follow-up time was 4 to 32 months, and the patients had no recurrence, with symmetrical buccal shape, and no traction and deformation in the affected buccal organs. In addition, the linear scar had no obvious hyperplasia and was hidden in the affected nasolabial folds, without symptoms of buccal nerve injury, and the shape of the corner of the mouth was normal. The width and opening degree of oral fissure were not significantly reduced compared with those before operation. Meanwhile, the intraoral flap was thin and flat, and healed well with the surrounding mucosa, without obvious flap contracture, buccal bite, or incomplete closure. CONCLUSION: Overall, V-shaped folded nasolabial flap has the advantages of flexible design, simple preparation, reliable blood supply, and protection of the donor site, which may be one of the effective methods for repairing small-sized and medium-sized defects in the anterior buccal mucosa.

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.

Midface Rejuvenation With Autologous Fat Grafting.

BACKGROUND: Midface rejuvenation is important to restore a youthful and appealing appearance. However, there are several problems existed in the treatment of fat grafting, including low fat retention and undesired aesthetic outcomes. OBJECTIVE: To objectively evaluate the efficacy of midface fat grafting, and analyze the problems encountered in this process to increase patient satisfaction. METHODS: Thirty-two patients who underwent autologous fat grafting for midface augmentation were included. Facial analysis was performed based on preoperative and postoperative photographs. Satisfaction outcome was assessed by the patient, the surgeon, and a layperson postoperatively. RESULTS: After treatment, 87.5% of the patients were assessed as satisfactory and mostly satisfactory based on facial proportion and complications. The postoperative medial cheek projection was 1.92±0.26 times the height of the preoperative one ( P <0.01). A smooth lid-cheek junction, a single convex, and ameliorated nasolabial groove were obtained. The dark coloration and wrinkles in lower eyelid were improved. The most common complication was overcorrection, which could be resolved with further treatments. CONCLUSIONS: Autologous fat grafting remains an optimal option for midface rejuvenation with satisfactory results. Most of the complications are preventable and optimal outcomes can be obtained through correct comprehension of aesthetic features and proper operations.

Efficacy and Safety of Polycaprolactone in Treating Nasolabial Folds: A Prospective, Multicenter, and Randomized Controlled Trial.

Nasolabial folds (NLFs) are the most pronounced sign of facial aging. This study explored the efficacy and safety of polycaprolactone gel in treating Chinese patients with moderate-to-severe NLFs. Patients with moderate-to-severe NLF who wished to be treated by dermal fillers were recruited from three centers between July 2017 and September 2019. The randomizing ratio was 1:1 in the polycaprolactone group (polycaprolactone injection) or control group (sodium hyaluronate gel injection). The primary endpoint was the effectiveness rate of Wrinkle Severity Rating Score (WSRS) scores at 12 months after injection. The full-analysis set (FAS) and safety sets had 80 patients in the polycaprolactone group and control group, respectively. In the FAS, the effectiveness rate at 12 months in the polycaprolactone group was 88.8% compared with 23.8% in controls (P < 0.001). The improvement in WSRS sustained during 12 months in the polycaprolactone group, while gradually vanished in the control group since 3 months after surgery. The global aesthetic improvement scale (GAIS) by investigator assessments was improved, much improved, or very much improved in all patients during follow-up, while the proportion of patients with a "no change" assessment gradually increased during follow-up after 6 months in the control group. The rates of injection-related adverse event (AE) and serve injection-related AE were 8.8 versus 11.3% and 0 versus 1.3% in the polycaprolactone group and control groups, respectively. Polycaprolactone gel injection is effective and safe to treat moderate-to-severe NLFs in Chinese patients.

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.

BACKGROUND: Hyaluronic acid is the most popular dermal filler in the treatment of nasolabial folds. Injection methods vary among physicians. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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. 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 . CLINICAL TRIAL REGISTRATION: This study was registered with the Chinese Clinical Trial Registry under the registration number ChiCTR2100041702.

Safety and Efficacy of Poly-L-Lactic Acid Filler (Gana V vs. Sculptra) Injection for Correction of the Nasolabial Fold: A Double-Blind, Non-Inferiority, Randomized, Split-Face Controlled Trial.

BACKGROUND: Poly-L-lactic acid (PLLA) fillers have shown excellent results as soft tissue fillers for progressive midface volume enhancement, with long-lasting results and high patient satisfaction. OBJECTIVE: Herein, we investigated the safety and effectiveness of a new PLLA filler (Gana V) in comparison with those of the widely used Sculptra. METHODS: This double-blind, non-inferiority, randomized, split-face controlled trial was performed in France to evaluate the safety and effectiveness of injectable Gana V compared with those of Sculptra for correction of nasolabial fold (NLF) depression. The primary outcome was improvement in NLFs, as determined using the Wrinkle Severity Rating Scale (WSRS). This trial is an interim report of the results at 6 months. The trial was registered at ClinicalTrials. gov, number NCT05215054. RESULTS: Fifty-five participants with moderate-to-severe NLFs (mean age 53.8 [standard deviation 8.7] years; 48 [87.3%]) female) were enrolled. After 6 months, Gana V showed improved WSRS score (mean difference - 0.25; 95% confidence interval [CI] - 0.49 to - 0.01) in intention-to-treat analysis, while Sculptra did not (mean difference - 0.20; 95% CI - 0.42 to 0.03). Furthermore, Gana V showed an acceptable 6-month effectiveness compared with Sculptra, within our defined non-inferiority margin (pnon-inferiority = 0.1787). The immediate results by the investigator after the initial injection showed higher satisfaction in the Gana V than in the Sculptra group. Gana V and Sculptra showed no difference in adverse reactions. Similar patterns were observed in per-protocol analyses. CONCLUSIONS: Gana V is non-inferior to Sculptra with respect to the correction of NLFs and has higher investigator satisfaction. Further research is required to ensure long-term safety. LEVEL OF EVIDENCE I: 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 .