Treatment Of Nasolabial Folds Research Articles

52823 A randomized, comparative study describing the gene signatures of Poly-L-Lactic Acid (PLLA-SCA) and Calcium Hydroxylapaptite (CaHA) in the treatment of nasolabial folds

52823 A randomized, comparative study describing the gene signatures of Poly-L-Lactic Acid (PLLA-SCA) and Calcium Hydroxylapaptite (CaHA) in the treatment of nasolabial folds

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 .

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.

Application of 3-Dimensional Technology for Evaluating Muscular Type and Muscle-Fat Pad Mixed-Type Nasolabial Folds With Botulinum Toxin-A Treatment.

Botulinum toxin-A (BTX-A) is used in the treatment of nasolabial folds (NLFs). However, lighting and clinician subjectivity play a major role in evaluating the efficacy of this treatment. By applying 3-dimensional (3D) technology, this study aimed to quantitatively evaluate the effects of BTX-A injection on muscular (M) and muscle-fat pad mixed-type (MF) NLFs. BTX-A was injected into bilateral marked points on the NLFs, where the levator labii alaeque nasi, zygomaticus minor, and zygomaticus major pull the skin to form the NLF (2 U at each injection site). Pretreatment and posttreatment 3D facial images were captured with static and laughing expressions. The curvature, width, depth, and lateral fat volume of the NLFs were measured to compare the therapeutic efficacy for type M and MF NLFs. Thirty-nine patients with type M and 37 with type MF NLFs completed the follow-up data. In these patients, the curvature, width, and depth of the NLF showed a significant reduction at 1 month and gradually recovered at 3 and 6 months after treatment, with more significant improvement when laughing than when static. Variations compared to the pretreatment values of type MF were greater than those of type M at each time point. The lateral fat volume of the type MF NLF was significantly reduced (P < .05). 3D technology can quantitatively evaluate the effects BTX-A injection for treating type M and type MF NLFs. BTX-A is more effective on type MF than on type M NLFs.

Calcium Hydroxyapatite Filler With Integral Lidocaine CaHA (+) for Soft Tissue Augmentation: Results from an Open-Label Multicenter Clinical Study.

Soft tissue augmentation with calcium hydroxylapatite (CaHA) is a versatile technique for line filling, skin tightening, lifting, contouring, and volumizing. The present study was designed to confirm safety and effectiveness of the product with lidocaine (CaHA (+)) in a holistic treatment of nasolabial folds (NLFs), marionette lines, and/or cheeks. A total of 207 subjects with moderate to severe facial volume deficit were treated with CaHA(+) in this open-label study. Effectiveness assessments included Merz Aesthetics Scales&reg; (MAS), investigator- and subject-assessed Global Aesthetic Improvement Scales (iGAIS/sGAIS), and FACE-QTM questionnaires. Responder rates were defined as at least one-point improvement on MAS according to blinded rating. Safety was assessed through adverse event reporting. Primary endpoint was evaluated 12 weeks after last injection. Responder rates were 93.6%, 88.7%, and 81.9% in the NLFs, marionette lines, and cheeks, respectively, and were statistically significant above the pre-defined 60% threshold (P&lt; 0.0001). Investigator- and subject-assessed GAIS were consistent and showed high rates of improvement throughout the study, with peak values of 98.0% at week 4 on iGAIS and 93.5% at 12 weeks after last injection on sGAIS. After 18 months, the majority of subjects (52.5%) still perceived improvement via sGAIS. Moreover, total FACE-Q scores demonstrated high subject satisfaction with treatment. All related treatment emergent adverse events were transient and expected injection-site reactions mostly of mild to moderate intensity. CaHA (+) has demonstrated safety and effectiveness in the treatment of NLFs, marionette lines, and cheek volume loss in real-life conditions up to 18 months. J Drugs Dermatol. 2022;21(5):481-487. doi:10.36849/JDD.6737.

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.

The use of resected SMAS as autologous graft for the correction of nasolabial folds during rejuvenating procedures.

Background and aim:Despite several techniques are proposed, treatment of nasolabial folds is often challenging. During rejuvenation procedures, the SMAS could be redraped or partially resected during the procedure. The aim of this study is to investigate the use of obtained SMAS strip as autologous graft, because of its solid but pliable consistence and fatty composition, to correct nasolabial folds during procedures with SMAS resection.MethodsBetween 2015 and 2018, 23 patients underwent SMAS graft for nasolabial fold correction. All procedures were performed under local anesthesia and no other cosmetic treatments, including HA fillers, have been done in the past 12 months.Results:22 patients were declared eligible for the study. 20 patients were female, accounting for 90,91%. Mean age was 53 years old. Ancillary procedures were performed in 17 patients, including upper blepharoplasty (3, 13,63%), upper and lower blepharoplasty (5, 22,73%) and submental neck lift with platysma plication (15, 68,18%). Mean follow-up was 9 months. No major complications have been recorded: only 1 case of minimal hematoma in the retroauricular region have been recorded and 1 patient required laser treatment for pathological scars. At follow-up, graft is completely integrated into the mid-fat compartment. As evinced from the FACE-Q analysis, the overall satisfaction rate is extremely high. These are very convincing data regarding the effectiveness of the technique and, despite a little bit longer downtime, is not invasive and led to natural long-lasting results event during motion.Conclusions:The use of SMAS graft during face-lift as nasolabial fold filler results in a satisfactory but natural filling of the folds, reducing the need for lateral tension and therefore assuring more natural results. Since its nature, SMAS, reduced in width to properly fit into the nasolabial fold, can be considered as an optimal autologous graft for replenish loss volumes of the face with aging. (www.actabiomedica.it)

Restylane + Lidocaine and Restylane Lyft for the Treatment of Nasolabial Folds

Restylane + Lidocaine and Restylane Lyft for the Treatment of Nasolabial Folds

Effects of Jae-Seng Acupuncture Treatment on the Improvement of Nasolabial Folds and Eye Wrinkles.

The microneedle therapy system (MTS), a mechanical method involving making minute multiple holes in the skin, reportedly improves skin condition, such as by reducing flushing and melanin. A newly attempted bloodletting therapy, Jae-Seng Acupuncture, has several advantages over traditional mechanical punching methods because it allows the practitioner to regulate the depth and direction of needle stimulations and to choose whether to stimulate the muscle layers. This study was conducted to determine the efficacy of Jae-Seng Acupuncture in the treatment of nasolabial folds and eye wrinkles. The nasolabial folds and eye wrinkles of 107 patients ranging in age from their 20s to their 70s were subjected to DermaVision, a digital skin image analyzer, before the treatment and one to six months after treatment. Additionally, stimulation of the meridians, such as Taeyang, Tongjaryo, Chongmyong, Sungup, Sabaek, Yonghyang, Chichang, Taeyong, was performed to improve the function of the stomach, large intestine. Analyses of the images indicate that Jae-Seng Acupuncture improved nasolabial folds and eye wrinkles, suggesting that this technique is a safe and effective method for the improvement of facial skin conditions.

Safety and efficacy of a novel injectable filler in the treatment of nasolabial folds: Polymethylmethacrylate and cross-linked dextran in hydroxypropyl methylcellulose

Nasolabial folds are a sign of aging and increasing number of people want filler injections in their nasolabial folds to look younger. Various dermal fillers are used for the correction of nasolabial folds. Recently, a novel injectible filler, polymethylmethacrylate (PMMA) and cross-linked dextran in hydroxypropyl methylcellulose, was introduced for facial contouring. This study was designed as a six-month, prospective, single-blinded, and open-label study in two centers located in Korea. Nineteen Korean patients received the novel filler injections on both nasolabial folds. At Weeks 4, 12, and 24, the efficacy and safety of the dermal filler were evaluated by blinded-investigators using clinical photographs. The mean Wrinkle Severity Rating Scale revealed significant decrease after dermal filler injections at each study visit. The decreased Wrinkle Severity Rating Scale was maintained for 6 months (p < 0.0001). The Global Aesthetic Improvement score showed an improvement greater than 2 in 95% of the per-proto col population 24 weeks after the injections. All patients (100%) experienced an improvement of their nasolabial folds at Week 24. There were no complications related to the novel filler injection. The novel dermal filler, PMMA, and cross-linked dextran in hydroxylpropyl methylcellulose, can be another safe and effective treatment option in the treatment of nasolabial folds.

Randomized, double-blind, half-side comparison of a monophasic CPM versus a biphasic NASHA dermal filler in the treatment of nasolabial folds

Randomized, double-blind, half-side comparison of a monophasic CPM versus a biphasic NASHA dermal filler in the treatment of nasolabial folds

Clinical comparison of two hyaluronic acid‐derived fillers in the treatment of nasolabial folds: Mesoglow® and IAL System®

Hyaluronic acid (HA) dermal fillers are widely used to reduce the appearance of aging. However, comparative research on the efficacy and safety of products of similar composition is limited. We compared outcomes achieved with two non-cross-linked HA fillers of almost identical composition, Mesoglow® and IAL System® . Forty subjects with visible nasolabial folds (NLFs) were enrolled in a randomized study. Wrinkle severity was rated using the 5-point Wrinkle Severity Rating Scale (WSRS). Each subject was injected with Mesoglow® in one NLF and IAL System® in the other. An optimal cosmetic result was established at two weeks after a second treatment. Participants were then reassessed at 2, 6, and 12 weeks, respectively, post-optimal cosmetic result using the WSRS. The degree of improvement was also assessed by subjects and investigators using the Global Aesthetic Improvement Scale (GAIS). At baseline, the mean WSRS score was 3.20 ± 0.41. At the optimal cosmetic result, 98% of subjects showed a 1- or 2-point change in WSRS score with either treatment. All subsequent WSRS scores were significantly improved over baseline for both treatments. There was no significant difference between treatments or improvement in WSRS score at any point in time. Investigator GAIS scores at weeks 4 and 6 were slightly but not significantly higher for Mesoglow®-treated skin. There was no significant difference in the frequency of local adverse responses. No serious systemic adverse events occurred. This study indicates that Mesoglow® and IAL System® are equally effective in achieving short-term correction of NLFs, but the longevity of their effects is limited.

Randomized, double-blind, half-side comparison of a monophasic and a biphasic stabilized hyaluronic acid–based gel of nonanimal origin in the treatment of nasolabial folds

Randomized, double-blind, half-side comparison of a monophasic and a biphasic stabilized hyaluronic acid–based gel of nonanimal origin in the treatment of nasolabial folds

Efficacy and Tolerability of Admixing 0.3% Lidocaine with Dermicol-P35 27G for the Treatment of Nasolabial Folds

Efficacy and Tolerability of Admixing 0.3% Lidocaine with Dermicol-P35 27G for the Treatment of Nasolabial Folds

Efficacy and safety of a novel hyaluronic acid dermal filler containing lidocaine for treatment of nasolabial folds in Fitzpatrick skin types IV to VI

Efficacy and safety of a novel hyaluronic acid dermal filler containing lidocaine for treatment of nasolabial folds in Fitzpatrick skin types IV to VI

A Multicenter Study of the Efficacy and Safety of Restylane in the Treatment of Nasolabial Folds in China

Sir: From 2005 to 2006, a study was carried out to determine the efficacy and safety study of Restylane (Medicis Aesthetics, Inc., Scottsdale, Ariz.) on the nasolabial fold in a Chinese population. This was an open-label, multicenter study. Subjects seeking augmentation therapy for nasolabial fold correction were recruited. Intradermal injection with Restylane was made at baseline, and a possible touch-up injection could be given 4 weeks later. The study consisted of a screening visit; a baseline visit; and follow-up visits after 4 weeks, 3 months, and 6 months. Efficacy was assessed subjectively by comparing the treatment results between before treatment and after treatment both by the investigator's evaluation and the subject's self-evaluation with the use of the Wrinkle Severity Rating Scale1 and the Global Aesthetic Improvement Scale. Safety was assessed by evaluation of adverse events following injection and the severity of the reported adverse events. Eighty-six subjects were recruited and treated and 75 subjects completed the 6-month follow-up period. All subjects were injected in both nasolabial folds and 14 subjects received a touch-up treatment in one or both nasolabial folds. After treatment, most subjects' nasolabial folds had improved bilaterally with one or two scores on the Wrinkle Severity Rating Scale. The efficacy analysis showed a very good treatment effect up to 6 months using the Wrinkle Severity Rating Scale. The percentage of responders was above 80 to 85 percent for both nasolabial folds, which is higher than in previous well-controlled randomized clinical studies in Europe and North America.2–4 As for assessments with the Global Aesthetic Improvement Scale, a large proportion of the subjects responded to treatment; 73 percent and 56 percent of subjects were responders at 6 months, according to investigators' and subjects' assessments, respectively. Posttreatment reactions of Restylane are anticipated after intradermal injection. The adverse events included 31 events related to the injection procedure (15.9 percent of the injections) and 11 events related to the study product (5.6 percent of the injections). By comparison with data from previous clinical studies with Restylane, it can be concluded that the frequency of these reactions in this Chinese study was similar to that in the published literature.2–4 A clear majority of the posttreatment reactions were mild and resolved spontaneously. Thus, it was concluded that the efficacy of Restylane for facial tissue augmentation in the Chinese population was excellent, with a high proportion of the subjects responding to treatment using two different scales for evaluation. Response was well sustained, with a significant improvement from baseline at all time points up to 6 months after treatment. Restylane was well tolerated, and no systemic reactions or other safety concerns were raised. Some mild, transient reactions were reported and resolved spontaneously without need of specific treatment. Xiaoqing Yan, M.D. Jun Xu, M.D. Division of Plastic Surgery Chinese People's Liberation Army General Hospital Changsheng Lu, M.D. Plastic Surgery Hospital Chinese Academy of Medical Sciences Yongguang Ma, M.D. Department of Plastic Surgery Peking University 3rd Hospital Wei Li, M.D. Division of Biometrics Clinical Pharmacology Center Fu Wai Hospital Chinese Academy of Medical Sciences Beijing, China

Treatment of nasolabial folds with porcine small intestinal submucosa

Treatment of nasolabial folds with porcine small intestinal submucosa

A 52-Month Summary of Results Using Calcium Hydroxylapatite for Facial Soft Tissue Augmentation

In this large-scale clinical review, we investigated the safety and efficacy of Radiesse, an injectable calcium hydroxylapatite (CaHA) implant, in treatment of nasolabial folds, marionette lines, and other areas of the face. After obtaining informed consent from the subjects, CaHA was injected in 1,000 patients (886 women and 114 men, ranging in age from 21 to 85 years) for a variety of facial aesthetic applications over a period of 52 months. Typically, CaHA was administered with a 27-gauge 1/2, or 1 1/4-inch needle. The nasolabial folds were the most frequently treated site, followed by the marionette lines/oral commissure. More than 80% of patients reported persistence of results at 12 months. The most frequently reported adverse events were erythema and ecchymosis. The formation of nodules was rare and was chiefly confined to the lips. Only two patients experienced nodule formation outside the lips. Over a period of more than 4 years, we found that CaHA performed well, with a favorable safety profile, high patient satisfaction, and good durability.

A Multicenter, 47-Month Study of Safety and Efficacy of Calcium Hydroxylapatite for Soft Tissue Augmentation of Nasolabial Folds and Other Areas of the Face

Each soft tissue filler product has its own unique profile in terms of adverse events. In this large-scale study, we investigated the safety profile of Radiesse, an injectable calcium hydroxylapatite (CaHA) implant, in treatment of nasolabial folds and other areas of the face. We also investigated the efficacy in a subset of the larger patient group. After obtaining informed consent from the subjects, researchers injected CaHA at two treatment centers into 113 patients (100 women and 13 men, ranging in age from 26 to 78 years) for a variety of facial aesthetic applications over a period of 47 months. Seventy-five patients had a single injection session; 38 had multiple sessions. Most patients (102) received 1.0 mL of CaHA per session; 12 received 2.0 mL per session. Typically, CaHA was administered with a 27-gauge 0.5- or 1 1/4-in. needle. Safety. Of 113 patients, only 7 reported minor adverse events that were short-term and resolved within 1 month: transient ecchymosis (3), nongranulatomous submucosal nodules of the lip (2), and inflammation and edema (2). Efficacy. Efficacy ratings were performed for a subset of patients (n=41). On a scale of 1 to 5 (1=unsatisfactory; 5=excellent), the mean patient evaluation score for look and feel of the implant was 4.6; the mean physician scores for the look and feel of the implant were 4.5 and 4.6, respectively. During the 6-month follow-up visit, patients' mean ratings of the look and feel of the implant were 4.8 and 4.9, respectively. The physician's mean ratings for the look and feel of the implant were 4.5 and 4.9, respectively. In our study, CaHA performed well, with a favorable safety profile, high patient satisfaction (90% of patients reported very good or excellent results), and good durability. We are especially pleased with the low incidence of adverse events coupled with the favorable responses from the patients themselves due to longevity of correction.

A Multicenter, 47-Month Study of Safety and Efficacy of Calcium Hydroxylapatite for Soft Tissue Augmentation of Nasolabial Folds and Other Areas of the Face

OBJECTIVES Each soft tissue filler product has its own unique profile in terms of adverse events. In this large-scale study, we investigated the safety profile of Radiesse, an injectable calcium hydroxylapatite (CaHA) implant, in treatment of nasolabial folds and other areas of the face. We also investigated the efficacy in a subset of the larger patient group. METHODS After obtaining informed consent from the subjects, researchers injected CaHA at two treatment centers into 113 patients (100 women and 13 men, ranging in age from 26 to 78 years) for a variety of facial aesthetic applications over a period of 47 months. Seventy-five patients had a single injection session; 38 had multiple sessions. Most patients (102) received 1.0 mL of CaHA per session; 12 received 2.0 mL per session. Typically, CaHA was administered with a 27-gauge 0.5- or 1 1/4-in. needle. RESULTS Safety. Of 113 patients, only 7 reported minor adverse events that were short-term and resolved within 1 month: transient ecchymosis (3), nongranulatomous submucosal nodules of the lip (2), and inflammation and edema (2). Efficacy. Efficacy ratings were performed for a subset of patients (n=41). On a scale of 1 to 5 (1=unsatisfactory; 5=excellent), the mean patient evaluation score for look and feel of the implant was 4.6; the mean physician scores for the look and feel of the implant were 4.5 and 4.6, respectively. During the 6-month follow-up visit, patients' mean ratings of the look and feel of the implant were 4.8 and 4.9, respectively. The physician's mean ratings for the look and feel of the implant were 4.5 and 4.9, respectively. CONCLUSIONS In our study, CaHA performed well, with a favorable safety profile, high patient satisfaction (90% of patients reported very good or excellent results), and good durability. We are especially pleased with the low incidence of adverse events coupled with the favorable responses from the patients themselves due to longevity of correction.