ABSTRACT
INTRODUCTION: To investigate the efficacy and safety of Cutegel® MAX (Cutegel) in the correction of moderate-to-severe nasolabial folds (NLFS) compared to Restylane® (Restylane, control). METHODS: This study was a 52-week, multicenter, randomized, double-blinded, active-controlled clinical trial. Qualified participants with moderate-to-severe NLFs were randomly assigned in a 1:1 ratio to receive Cutegel or Restylane. For the primary efficacy endpoint, the response rate was defined as the percentage of subjects exhibiting an improvement of at least one-point based on blinded evaluation of Wrinkle Severity Rating Scale (WSRS) at 24 weeks after injection. Other secondary efficacy endpoints and treatment-emergent adverse events (TEAEs) were assessed. RESULTS: Of 340 subjects randomized, 317 completed the week 52 visit. In the per protocol set (PPS), the blinded evaluator-assessed response rates at week 24 were 81.17% for Cutegel versus 77.56% for Restylane (p = 0.327). The between-group treatment differences in response rates were 3.60% [95% confidence interval (CI) = (-5.39%, 12.60%)], which demonstrated the noninferiority of Cutegel. Other secondary efficacy endpoints supported this. No significant differences were observed in the occurrence of adverse events between the two groups. CONCLUSION: Similar to Restylane, Cutegel was effective and well tolerated in correcting moderate-to-severe NLFs among the Chinese population.
Nasolabial folds (NLFs) are among the early indicators of facial aging process. In the past, rhytidectomy has been considered a safe procedure, yet it continues to carry risks such as hematoma, skin necrosis, nerve injury, and infection. With the ongoing development of biomaterials including hyaluronic acid (HA), minimally invasive injection procedures for the aesthetic correction of NLFs have become the preferred choice in recent years. The widespread use of HA has resulted in the development of various types of commercial HA fillers, such as Cutegel and Restylane. It is well known that HA filler products produce varying effects, attributable to differences in their components and physical properties. Previous studies have established that Restylane is a safe and effective HA dermal filler for the correction of NLFs. However, there is a lack of studies on both the cosmetic results and safety data for Cutegel in the published literature. Therefore, a randomized, double-blinded, active-controlled clinical trial was conducted at seven Chinese hospitals to evaluate the efficacy and safety of Cutegel for the correction of moderate-to-severe NLFs, compared to the approved Restylane in China. Among the 340 randomized subjects, 170 subjects received Cutegel, and 169 subjects received Restylane. Both groups reported similar improvements in WSRS (the between-group treatment differences in response rates exceeded the prespecified noninferiority margins), and also in other efficacy evaluations. Additionally, the two treatment groups showed similar safety profiles. In summary, Cutegel proved to be well tolerated and effective in this randomized, active-controlled clinical study, demonstrating its noninferiority to Restylane and validating its use as an alternative treatment for Chinese subjects with moderate-to-severe NLFs.
Subject(s)
Dermal Fillers , Hyaluronic Acid , Nasolabial Fold , Skin Aging , Adult , Female , Humans , Male , Middle Aged , China , Cosmetic Techniques , Dermal Fillers/administration & dosage , Double-Blind Method , East Asian People , Follow-Up Studies , Hyaluronic Acid/administration & dosage , Hyaluronic Acid/analogs & derivatives , Skin Aging/drug effects , Treatment OutcomeABSTRACT
BACKGROUND: Hyaluronic acids (HAs) can have very different actions not only depending on injector and host factors but also depending on their molecular weight. Whereas short chain HA has immunological activity long chain HA influences fibroblasts and may stimulate them to produce collagen. Although this is generally thought to be a positive feature it may be disadvantageous in certain localizations. PATIENTS AND METHODS: We have encountered 23 patients who developed fibrous tissue next to the nasolabial folds accentuating them and becoming very obvious while smiling. Hyaluronidase injection did not reduce this mass. RESULTS: Intralesional triamcinolone acetonide injection led to rapid improvement. DISCUSSION: Fibrotic tissue reaction not responding to hyaluronidase may be the result of HA injection and can effectively be treated with intralesional steroid injection.
Subject(s)
Cosmetic Techniques , Dermal Fillers , Fibrosis , Hyaluronic Acid , Triamcinolone Acetonide , Humans , Hyaluronic Acid/adverse effects , Hyaluronic Acid/administration & dosage , Dermal Fillers/adverse effects , Dermal Fillers/administration & dosage , Female , Middle Aged , Triamcinolone Acetonide/administration & dosage , Triamcinolone Acetonide/adverse effects , Cosmetic Techniques/adverse effects , Adult , Hyaluronoglucosaminidase/administration & dosage , Injections, Intralesional/adverse effects , Nasolabial Fold , Male , Face , Glucocorticoids/administration & dosage , Glucocorticoids/adverse effectsABSTRACT
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.
Subject(s)
Cosmetic Techniques , Dermal Fillers , Hyaluronic Acid , Nasolabial Fold , Skin Aging , Humans , Hyaluronic Acid/administration & dosage , Hyaluronic Acid/adverse effects , Dermal Fillers/administration & dosage , Dermal Fillers/adverse effects , Female , Prospective Studies , Middle Aged , Double-Blind Method , Male , Skin Aging/drug effects , Adult , Treatment Outcome , AgedABSTRACT
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.
Subject(s)
Nasolabial Fold , Skin Transplantation , Humans , Young Adult , Adult , Middle Aged , Skin/diagnostic imaging , Imaging, Three-Dimensional , TechnologyABSTRACT
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.
Subject(s)
Patient Satisfaction , Rejuvenation , Rhytidoplasty , Suture Techniques , Humans , Female , Middle Aged , Rhytidoplasty/methods , Adult , Male , Subcutaneous Fat/surgery , Aged , Face , Nasolabial Fold/surgery , Skin Aging , Treatment Outcome , PhotographyABSTRACT
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.
Subject(s)
Arteries , Face , Nasolabial Fold , Ultrasonography, Doppler, Color , Humans , Female , Male , Adult , Middle Aged , Adolescent , Nasolabial Fold/diagnostic imaging , Young Adult , Face/blood supply , Face/diagnostic imaging , Ultrasonography, Doppler, Color/methods , Arteries/diagnostic imaging , Sex FactorsABSTRACT
Perioral tissues are among the first areas to show signs of facial aging, leading many patients to seek perioral fillers as their initial cosmetic treatment. These fillers offer a temporary solution by enhancing volume and reducing common facial lines. Various regions within the perioral area can be targeted, including the lips, nasolabial folds, philtral columns, vertical lip rhytids, oral commissures, melomental folds, mentolabial folds, and nasolabial folds. The technique for injecting perioral fillers depends on the specific region, chosen product, and the desired outcome of augmentation.
Subject(s)
Cosmetic Techniques , Cosmetics , Skin Aging , Humans , Lip/surgery , Nasolabial Fold , Hyaluronic Acid , Treatment OutcomeABSTRACT
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.
Subject(s)
Clinical Relevance , Physicians , Humans , Nasolabial Fold , Reproducibility of Results , EstheticsABSTRACT
OBJECTIVES: To summarize the clinical characteristics and prognosis of children with nasolabial fold rhabdomyosarcoma (RMS). METHODS: Retrospective review of children treated for nasolabial fold RMS from January 2014 to September 2019. RESULTS: Of 21 patients with nasolabial fold RMS, 90.48% were alveolar subtype, in which PAX3/7-FOXO1 fusion positive accounted for 87.5%. Ten patients (47.62%) had nodals invasion. Almost all patients received comprehensive treatment (chemotherapy [100%], radiation therapy [100%], and surgery [95.24%]). The median follow-up time was 34.3 months. The 3-year overall survival (OS) and event-free survival (EFS) was 67.7% ± 14.1% and 42.1% ± 13.5%, respectively. Four patients had regional lymph node relapse (NR), all in the ipsilateral submandibular lymph node region. CONCLUSION: Majority of the patients with RMS in the nasolabial fold area were alveolar subtype and had positive PAX3/7-FOXO1 gene fusion. In addition, the nasolabial fold RMS had a high probability of regional lymph node metastasis in the submandibular area. To maintain the facial aesthetics and functions, the surgical area for nasolabial fold RMS is often very conservative and restricted. This could be one of the contributors for the poor prognosis of nasolabial fold RMS beside its worse pathological subtype and gene fusion.
Subject(s)
Nasolabial Fold , Rhabdomyosarcoma , Child , Humans , Nasolabial Fold/pathology , Neoplasm Recurrence, Local , Rhabdomyosarcoma/therapy , Rhabdomyosarcoma/pathology , Prognosis , Antineoplastic Combined Chemotherapy Protocols/therapeutic useABSTRACT
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.
Subject(s)
Cosmetic Techniques , Skin Aging , Humans , Polymers/adverse effects , Retrospective Studies , Lactic Acid/therapeutic use , Polyesters , Nasolabial FoldABSTRACT
BACKGROUND AND OBJECTIVE: The deepening of the nasolabial fold (NLF) is a common occurrence during the aging process, necessitating the development of an objective method to evaluate changes in NLFs. The objective of our study was to introduce a method of depth deviation based on three-dimensional (3D) image for evaluating the efficacy of hyaluronic acid (HA) injection in correcting NLFs. METHODS: Between May 2019 and November 2019, we recruited 56 Chinese volunteers with moderate to severe NLFs for this study. The participants received HA injections and were followed up for a period of 12 months. Pre and posttreatment, we collected the Wrinkle Severity Rating Scale (WSRS) scores and 3D images. To assess the efficacy of NLF correction, we used the maximum value of depth deviation (MVD) based on 3D images and the Global Aesthetic Improvement Scale (GAIS) score. Additionally, we compared the relationship between MVD and other clinical parameters. RESULTS: Fifty-four female participants completed the study and were included in the analysis. The HA injection resulted in a significant decrease in NLF severity (p < 0.05). One month after the injection, the average GAIS score was 4.72 ± 0.45, and the average MVD was 2.10 ± 0.56 mm. Both the GAIS score and the average MVD exhibited a decline over time during the follow-up period, with the average MVD showing a significant correlation with the GAIS score at all time points (p < 0.05). CONCLUSIONS: Using 3D technology, we demonstrated that the quantitative data provided by MVD can serve as an objective method for evaluating the correction of NLFs.
Subject(s)
Cosmetic Techniques , Dermal Fillers , Skin Aging , Humans , Female , Nasolabial Fold , Imaging, Three-Dimensional , Prospective Studies , Hyaluronic Acid , Treatment OutcomeABSTRACT
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 .
Subject(s)
Cosmetic Techniques , Dermal Fillers , Humans , China , Hyaluronic Acid , Nasolabial Fold , Personal Satisfaction , Prospective Studies , Treatment Outcome , Randomized Controlled Trials as Topic , Multicenter Studies as TopicABSTRACT
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.
Subject(s)
Cosmetic Techniques , Dermal Fillers , Skin Aging , Humans , Hyaluronic Acid , Dermal Fillers/adverse effects , Nasolabial Fold , Cosmetic Techniques/adverse effects , Skin Pigmentation , Treatment OutcomeABSTRACT
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.
Subject(s)
Cosmetic Techniques , Cutis Laxa , Dermal Fillers , Rhytidoplasty , Skin Aging , Humans , Rhytidoplasty/adverse effects , Rhytidoplasty/methods , Nasolabial Fold/surgery , Prospective Studies , Cutis Laxa/drug therapy , Hyaluronic Acid/therapeutic use , Adipose Tissue , Treatment OutcomeABSTRACT
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.
Subject(s)
Facial Neoplasms , Skin Neoplasms , Humans , Male , Female , Patient Satisfaction , Mohs Surgery , Skin Neoplasms/surgery , Skin Neoplasms/psychology , Nose/surgery , Facial Neoplasms/surgery , Nasolabial Fold/surgeryABSTRACT
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.
Subject(s)
Cosmetic Techniques , Skin Aging , Humans , Female , Nasolabial Fold/surgery , Skin , Rejuvenation , Lasers , Treatment Outcome , Cosmetic Techniques/adverse effectsABSTRACT
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.
Subject(s)
Rejuvenation , Skin , Adult , Humans , Skin/diagnostic imaging , Ultrasonography , Aging , Nasolabial FoldABSTRACT
INTRODUCTION: The injectable skin fillers available for soft tissue augmentation are constantly growing, providing esthetic surgeons with more options in the treatment of scars, lines, and wrinkles. Hyaluronic acid (HA)-derived injectable fillers are ideal to reduce the appearance of nasolabial folding. This study investigated the efficacy and safety of the commercially available HA filler from Maxigen Biotech Inc. (MBI-FD) in the treatment of nasolabial folds (NLFs). METHODS: We analyzed 1,4-butanediol diglycidyl ether (BDDE) residues and injection force test and observed the protein content in MBI-FD, and then was cultured in fibroblast L929 cells and examined for cytotoxicity. Finally, 95 healthy participants underwent dermal filler injection therapy to evaluate the efficacy and safety for 24 and 52 weeks, respectively. RESULTS: BDDE residues in MBI-FD was <0.125 µg/mL. MBI-FD was fitted using 27- and 30-G injection needles with an average pushing force of 14.30 ± 2.07 and 36.43 ± 3.11 N, respectively. Sodium hyaluronate protein in MBI-FD was 7.19 µg/g. The cell viabilities of 1× and 0.5× MBI-FD were 83.25% ± 3.58% and 82.23% ± 1.85%, respectively, indicating MBI-FD had no cytotoxicity, and decreased NLF wrinkles with no serious adverse events. CONCLUSION: MBI-FD is an effective filler for tissue augmentation of the NLFs and may be a suitable candidate as an injectable dermal filler for tissue augmentation in humans in the future.
Subject(s)
Cosmetic Techniques , Dermal Fillers , Skin Aging , Humans , Hyaluronic Acid/therapeutic use , Dermal Fillers/adverse effects , Nasolabial Fold , Cosmetic Techniques/adverse effects , Double-Blind Method , Treatment OutcomeABSTRACT
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.
Subject(s)
Forehead , Skin , Female , Humans , Body Mass Index , Skin/diagnostic imaging , Epidermis , Nasolabial FoldABSTRACT
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 .