Wrinkle Severity Rating Scale Score Research Articles

A Safe Doppler Ultrasound–Guided Method for Nasolabial Fold Correction With Hyaluronic Acid Filler

Injection of hyaluronic acid filler, a common procedure for nasolabial fold correction, poses a risk of vascular compromise, which can result in skin necrosis and blindness. The aim of this study was to examine the facial arterial pathway in real time by Doppler ultrasound to avoid arterial complications during filler injections. The facial artery pathway of 40 patients (80 nasolabial folds; 2 men and 38 women; mean age, 46.5 years; range, 28-72 years) was examined by Doppler ultrasound before hyaluronic acid filler injection. On the basis of this ultrasound evaluation, the filler injection targeted the subdermal, subcutaneous, and deep to submuscular layers by bypassing the facial artery. The efficacy of the filler injection was evaluated for each patient. The facial artery was detected lateral to the nasolabial fold in 31% of patients; it was detected beneath the nasolabial fold in the other patients as follows: subdermal layer, 13%; subcutaneous layer, 29%; muscular layer, 24%; and submuscular layer, 4%. The mean [standard deviation] Wrinkle Severity Rating Scale score was 3.68 [0.76] before injection and 2.28 [0.78] at 3 months after injection. Two patients experienced unilateral bruising of the nasolabial fold, which resolved after 2 weeks without treatment. Doppler ultrasound can be considered as pretreatment tool for the prevention of vascular complications during filler injections to correct nasolabial folds.

Reduced pain with injection of hyaluronic acid with pre-incorporated lidocaine for nasolabial fold correction: A multicenter, double-blind, randomized, active-controlled, split-face designed, clinical study.

Injection of hyaluronic acid (HA) filler for nasolabial fold (NLF) correction is a popular aesthetic procedure. In relation to HA filler injections, effective pain control for patient comfort is an important concern. We compared the pain relief achieved by HA filler with 0.3% lidocaine (HAF-Lidocaine) with that achieved by HA filler without lidocaine (HAF) for NLF correction. A total of 62 subjects with visible NLFs were enrolled in this double-blind study at two university hospitals and injected with HAF-Lidocaine and HAF, randomly assigned to the each NLFs. Subjects assessed pain using the visual analog scale (VAS). Blinded independent dermatologists assessed the Wrinkle Severity Rating Scale (WSRS) and subjects assessed the Global Aesthetic Improvement Scale (GAIS) for the evaluation of effectiveness. All adverse events during the follow-up period were recorded. Immediately after treatment, 95.2% of subjects who were treated with HAF-Lidocaine reported reduced pain when compared with those who were treated with HAF and the mean VAS score difference was 38.6mm. At 15, 30, 45, and 60minutes after treatment, respectively, 67.7%, 41.9%, 32.3%, and 21.0% of subjects experienced reduced pain. Based on the mean WSRS and GAIS scores and the incidence of local injection site reactions, the clinical effectiveness and safety profile of HAF-Lidocaine were comparable to those of HAF. We conclude that HA filler containing pre-incorporated lidocaine could reduce pain in Korean patients for NLF correction, and the addition of lidocaine does not affect the effectiveness and safety of HA filler.

The efficacy and safety of DermalaxTM DEEP in the correction of moderate to severe nasolabial folds: a multicenter, randomized, double-blind clinical study

Background To investigate the efficacy and safety of Dermalax in the correction of moderate to severe nasolabial folds (NLFs) compared to Restylane. Methods A total of 324 subjects with moderate to severe NLFs were enrolled in this multicenter, randomized, double-blind, active-controlled clinical study. Eligible subjects were randomly assigned to the test group received Dermalax injection (n = 162) or control group received Restylane injection (n = 162). Clinical efficacy and safety were assessed based on the Wrinkle Severity Rating Scale (WSRS) and the Global Esthetic Improvement Scale(GAIS) at weeks 2, 8, 16, 24, 36 and 48 weeks after injection. Results At week 24, similar improvements of effective rate were obtained on the Dermalax group (93.75%) and Restylane group (89.44%). Significances were found at 36 weeks and 48 weeks after injection, Dermalax seemed be better than Restylane in maintaining the effect in the later period. The improvement of mean WSRS score for test group was superior to that of control group with significance. GAIS scores rated at week 24 were 1.65 VS 1.94 (p < .001) and 2.10 VS 2.27 (p = .060), seperately. Conclusions Dermalax was no inferior to or better than that of the control filler Restylane in correcting of moderate to severe NLFs in Chinese subjects.

Elastic thread modified minimal access cranial suspension lift for lower and middle third facial rejuvenation.

Thread lift boasts the advantage of minimal invasion for facial rejuvenation and has been increasingly used nowadays. The purpose of this study was to evaluate the outcomes and safety of elastic thread when it was used in the modified minimal access cranial suspension (MACS) lift for rejuvenation of the lower and middle third of the face.Forty-six patients with sagging and laxity of the lower face treated by the elastic thread modified MACS lift from December 2015 and December 2017 were enrolled in this study. A retrospective chart review was conducted. The degree of Wrinkle Severity Rating Scale (WSRS) score and satisfaction score were evaluated immediately, 6 months and 12 months after procedure. Complications during the study were also recorded.All the patients were female, with a mean age of 50.7 ± 6.4 years and a mean follow-up period of 15.4 ± 2.1 months. The mean operation time was 114 ± 13 minutes. For the left face, the mean WSRS score was 4.0 ± 0.8 preoperatively and 3.1 ± 0.8 on the 1-year follow-up; and 4.1 ± 0.9 and 3.1 ± 0.7 on the right face (P < .01). Thirty-nine (84.8%) patients considered the long-term results satisfactory. There were no major complications during the follow-up period.The elastic thread modified MACS lift is a minimally invasive, effective and safe method to improve lagging middle and lower third of the face without significant postoperative morbidity or complications.

The Efficacy and Safety of Hyaluronic Acid Microinjection for Skin Rejuvenation in Vietnam.

BACKGROUND:Aging is an increasing concern of modern society, particularly facial ageing. In recent years, the microinjection technique has increasingly been emphasised as a skin rejuvenation strategy. Hyaluronic acid (HA) plays an important role in the hydration of the extracellular space and can thus improve skin hydration, firmness and viscoelastic properties.AIM:To evaluate the efficacy and safety of HA microinjection in skin rejuvenation.METHODS:We enrolled thirty participants underwent three sessions of HA microinjection involving multiple injections in the face or back of the hands at 2-week intervals. The aesthetic outcomes were assessed at baseline and after 2, 4 and 8 weeks. Clinical evaluation was based on the Global Aesthetic Improvement Scale (GAIS) and the Wrinkle Severity Rating Scale (WSRS).RESULTS:Evaluation of photographs from 2, 4 and 8 weeks revealed significant clinical improvement in the brightness, texture and wrinkling of the skin. Analysis of the GAIS and WSRS scores revealed statistically significant results after 2 months.CONCLUSION:Most of the participants felt satisfied with the treatment (93.3%).

Randomized Double-Blind Controlled Study on the Safety and Efficacy of a Novel Injectable Cross-linked Hyaluronic Gel for the Correction of Moderate-to-Severe Nasolabial Wrinkles

The current study compares two hyaluronic acid fillers, Ial System Duo and Belotero Basic/Balance, for the treatment of wrinkles. This is a single-center, double-blind randomized controlled study. Inclusion criteria consisted of subjects with bilateral nasolabial wrinkles. Each subject was treated with both products: One was applied on the right side and the other on the left side of the face. The quantity of product injected and any problems or local reactions (erythema, edema, pain or itching) were recorded and reassessed at 3 and 6months and then monthly until complete absorption of the product. The Wrinkle Severity Rating Scale (WSRS) and the Global Aesthetic Improvement Scale (GAIS) were used for the assessment, as well as an ultrasound measurement of the skin thickness. Complete data were available for 59 subjects. At 3 and 6months, both products showed improvement in the WSRS and GAIS score in the areas treated compared to pre-treatment assessments, although no significant differences were observed between them. No resulting significant differences were observed on skin thickness among the two products, which were completely reabsorbed in 285 ± 34days (Ial System Duo) and 277 ± 34days (Belotero Basic/Balance; Student's t test: p = 0.2181). No significant differences were observed with regard to the subject's satisfaction and adverse events. The Ial System Duo achieves long-term permanence (more than 9months confirmed by ultrasound) in correction of moderate and severe wrinkles, similar to Belotero Basic/Balance. Both products showed a high safety profile and a high degree of subject and physician satisfaction. 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, safety and patients’ satisfaction of a new treatment for facial ageing with topical autologous platelet rich plasma mixed with hyaluronic acid after microneedling: results of a single centre preliminary study

Introduction: Platelet Rich Plasma (PRP) and Hyaluronic acid (HA) have been proven to be effective in skin rejuvenation. The aim of this single Centre pilot study was to demonstrate the effectiveness and the safety of a new mixture of PRP and HA applied topically after microneedling to rejuvenate chrono- and photo-damaged facial skin. Methods: ten patients aged 43.3+7.7years, Glogau&gt;II were enrolled in the study and underwent three treatments each. After preparation, PRP was mixed with non-cross-linked HA and administered topically after microneedling of the facial skin. The Wrinkle Severity Rating Scale (WSRS) and the Global Aesthetic Improvement Scale (GAIS) were used respectively by a Plastic Surgeon and by the patients to assess effectiveness of the technique. Results: No early and/or late complications were observed after the treatments. Both WSRS and GAIS score improved with statistical significance before and after the procedures and comparing the first and second, second and third and, most of all, first and third topical application. No significant differences were found comparing subgroups of patients based on age (&lt;49 or &gt;50), smoking habits (smokers and non-smokers), patients who practised sports or not, patients taking drugs for pre-existing disease or not, summer sun-exposed patients or not. Conclusion: This new mixture of PRP-HA with the minimally invasive method of application (topical after microneedling) has proven to be effective and free of side effects in our series. Further studies with a greater number of enrolled patients are needed in order to confirm our results.

Platelet rich plasma for photodamaged skin: A pilot study.

Despite increasing popularity of platelet-rich plasma (PRP) in treating aging facial skin, the quality of evidence supporting its use is poor due to the lack of consistent methods of its preparation and application. This study was conducted to assess treatment efficacy and patient satisfaction with a single PRP treatment prepared with a simplified preparation and application technique. Four millilitre of PRP were injected into 6 standardized points on each side of the face. Outcomes were assessed by independent physician evaluation of pretreatment and posttreatment photographs using the Wrinkle Severity Rating Scale (WSRS) and Global Aesthetic Improvement Scale (GAIS). In addition, patient-reported outcomes were evaluated using the FACE-Q. Thirty-one participants ranging from 27 to 71 years of age (median, 38; IQR 32-58) were recruited for this study. Posttreatment WSRS scores improved in only 1 patient; the GAIS scores of 14 patients indicated aesthetic improvement. Analysis of FACE-Q scores revealed statistically significant increases in participant satisfaction with overall facial appearance and cheeks. The most frequently reported adverse effects were tenderness (23.4%; 7 of 31), facial tightness (20.0%; 6 of 31), and swelling (20.0%; 6 of 31). A simple method of PRP preparation offers modest benefit in treating the effects of skin aging and photodamage. Future research studies should alter our methods using a stepwise approach to optimize the treatment of aging facial skin with PRP.

Effectiveness and Safety of Hyaluronic Acid Gel with Lidocaine for the Treatment of Nasolabial Folds: A Systematic Review and Meta-analysis

Hyaluronic acid (HA) gel is a widely used dermal filler for the correction facial volume loss. The incorporation of lidocaine with HA provides a pain-relieving alternative for individuals considering facial rejuvenation. The aim of this systematic review and meta-analysis is to compare the effectiveness and safety of HA with lidocaine (HAL) with that of HA without lidocaine for the treatment of nasolabial folds (NLFs). Studies were identified using the electronic databases PubMed, Embase, Cochrane Central Register of Controlled Trials and Web of Science from inception up to January 2018. Randomized controlled trials (RCTs) were selected based on the inclusion criteria. Outcomes included 100-mm Visual Analogue Scale (VAS) score, Wrinkle Severity Rating Scale score and adverse events. A total of 908 patients from 12 RCTs were included in the meta-analysis. VAS score within 30min after injection in the HAL group was much lower than that with just HA group (MD = -28.83, 95% CI -36.38 to -21.28). There was no significant difference in effectiveness between the two products 24months post-injection (MD = 0.13, 95% CI -0.15 to 0.41). The main adverse events, such as swelling, erythema, bruising, itching and induration, also showed no significant difference. HAL is more effective for pain relief than HA alone, but both display similar effectiveness and safety for the correction of NLFs. 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 .

Clear aligners' effects on aesthetics: evaluation of facial wrinkles.

BackgroundTo evaluate the facial aesthetic effects of orthodontic treatment performed with clear aligners and to compare it to an untreated control group, on lower third facial ageing in adult patients through the use of the Wrinkle Severity Rating Scale (WSRS) at the beginning (T0) and at the end (T1) of the study period.Material and MethodsA clear aligners treated group (TG) of 68 patients was compared to a control group of 33 untreated patients (UG). Each group was divided in 2 subgroups according to age: subgroup 1 if under 40 years of age and subgroup 2 if over. Facial aesthetics of the lower third was evaluated at T0 and T1 by a panel of five aesthetic experts with WSRS.ResultsStatistically significant changes were found in all subgroups comparing WSRS scores at T0 and T1. The between group comparisons revealed that wearing clear aligners produces a statistically relevant improvement in lower third facial aesthetics both in younger (p< 0.05) and older (p< 0.001) patients.ConclusionsThe present retrospective cohort study has successfully shown that malocclusion therapy conducted through the use of clear aligners in a population of adults affected by dental crowding has beneficial effects on lower third facial ageing. Key words:Orthodontics, clear aligners, facial aesthetics, facial wrinkles, compliance.

Effects of highly concentrated hyaluronic acid filler on nasolabial fold correction: A 24-month extension study

Background: A previous 6-month study using a more highly concentrated novel hyaluronic acid (HA) filler, PP-501-B, found nasolabial fold (NLF) improvements with increased tolerability.Objective: We investigated the long-term efficacy, durability and safety of PP-501-B in the correction of NLFs.Methods: Subjects completing the initial six-month study were enrolled in this 24-month, randomized, multicenter, double-blind, split-face, extension study. The injection areas and treatment procedures were identical to those of the initial study: each subject was injected with PP-501-B in one NLF and with Restylane Perlane (Q-med) in the contralateral NLF. We reassessed wrinkle improvement using the five-point Wrinkle Severity Rating Scale (WSRS) and changes in the Global Aesthetic Improvement Scale at 12, 18 and 24 months after the initial treatment.Results: Of the 81 patients enrolled, 72 completed the study. The WSRS score significantly decreased from baseline throughout the follow-up period after retreatment with both fillers. There was no significant difference in the WSRS scores between the two fillers at 24 months. Both fillers were well tolerated with no severe complications or adverse reactions.Conclusion: The new HA filler PP-501-B is safe and effective in the long term for the correction of moderate-to-severe NLFs, even after a second treatment.

A Phase III, Randomized, Multi-Center, Double-Masked, Matched-Pairs, Active-Controlled Trial to Compare the Efficacy and Safety between Neuramis Deep and Restylane in the Correction of Nasolabial Folds.

BackgroundWe conducted this clinical study to compare the efficacy and safety between Neuramis Deep and Restylane in the correction of nasolabial folds.MethodsIn this phase III, randomized, multi-center, double-masked, matched-pairs, active-controlled trial (ClinicalTrials.gov Identifier: NCT01585220), we evaluated a total of 67 subjects (n=67). All the subjects underwent Neuramis Deep treatment on one side and Restylane on the contralateral side of the bilateral nasolabial folds at a ratio of 1:1. To compare the efficacy of Neuramis Deep and Restylane, we evaluated the Wrinkle Severity Rating Scale scores and those of the Global Aesthetic Improvement Scale. In addition, we compared the safety of Neuramis Deep and Restylane based on adverse events, physical examination, and clinical laboratory tests.ResultsNeuramis Deep was not inferior in improving the nasolabial folds as compared with Restylane. In addition, there was no significant difference in the efficacy between Neuramis Deep and Restylane. There were no significant differences in safety parameters between Neuramis Deep and Restylane.ConclusionsIn conclusion, our results indicate that Neuramis Deep may be a safe, effective material for improving the nasolabial folds. However, further studies are warranted to compare the tolerability of Neuramis Deep and Restylane based on histopathologic findings.

Comparative study of the effectiveness and safety of porcine and bovine atelocollagen in Asian nasolabial fold correction

Bovine-derived collagen has been used for soft-tissue augmentation since 1977. However, there are issues regarding the possibility of bovine spongiform encephalopathy (BSE). Researchers discovered that the histologic structure of porcine-derived collagen is similar to that of human dermal collagen and that it is free from the risk of BSE. This study was conducted to establish the effectiveness and safety of porcine-derived collagen compared to bovine-derived collagen. The 73 patients included in this study were healthy volunteers who responded to an advertisement approved by the Institutional Review Board (IRB). They had visited the authors’ hospital complaining of wrinkles on their nasolabial fold. Either porcine (TheraFill®) or bovine atelocollagen was randomly injected into each side of their nasolabial folds, and the five-grade Wrinkle Severity Rating Scale (WSRS) was used to evaluate the wrinkles before and after the injection. The average age of the 73 study patients was 46.18 years. The WSRS scores of the porcine and bovine atelocollagen-injected patients were 2.90 ± 0.71 and 2.85 ± 0.72 at the baseline and 2.15 ± 0.70 and 2.21 ± 0.67 after 6 months. There were no statistically significant differences between the two groups. Adverse effects of the porcine atelocollagen injection were seen in 12 patients, with the most common symptom being redness. This study showed that porcine atelocollagen can be used easily and without the need for the skin testing which is necessary before bovine atelocollagen injection. The efficacy of porcine atelocollagen is also similar to that of bovine atelocollagen.

The efficacy, longevity, and safety of combined radiofrequency treatment and hyaluronic Acid filler for skin rejuvenation.

BackgroundRecent advances in hyaluronic acid (HA) fillers and radiofrequency (RF) devices have been made in the context of skin rejuvenation and cosmetic surgery. Moreover, combination regimens with both techniques are currently being developed.ObjectiveThe present study was designed to examine the clinical and histologic effects of a new needle that incorporates an RF device for HA injections.MethodsA new intradermal needle RF device (INNOfill; Pacific Pharma, Korea) was assessed in the present study. In the animal arm, procollagen production was measured by using enzyme-linked immunosorbent assay, the filler volume was quantified by incorporating a dye with filler, and the filler distribution was assessed through the changes in tissue structure. In the human arm, the efficacy of the combination regimen was assessed by using the wrinkle severity rating scale (WSRS).ResultsIn the animal study, RF treatment increased procollagen production in a time-dependent fashion. The total volume was significantly increased with the RF treatment when compared with the filler injections alone, and lasted for up to 7 weeks after treatment. Additionally, the filler distribution was reduced in animals treated with RF when compared with the untreated group. In the human study, the nasolabial folds of subjects treated with RF before filler injections exhibited a significantly greater change in the WSRS score from baseline when compared with the nasolabial folds treated with filler injections alone.ConclusionA new device incorporating RF treatment before HA filler injection may represent a biocompatible and long-lasting advance in skin rejuvenation.

A combination trial of intradermal radiofrequency and hyaluronic acid filler for the treatment of nasolabial fold wrinkles: A pilot study

Background: Within the last few years, hyaluronic acid (HA) fillers and radiofrequency (RF) devices have shown significant promise for skin rejuvenation. But the effects of HA only lasted for a relatively short duration. Therefore, we tried a new combination therapy of intradermal RF and HA filler. Objective: To evaluate the clinical efficacy of combination therapy of intradermal RF and HA filler for nasolabial fold (NLF) wrinkle reduction. Materials and methods: Ten Korean female volunteers with mild to severe NLFs were enrolled. In the control group, five subjects were treated with HA filler alone. In the experimental group, the other five subjects were treated with intradermal RF prior to HA filler. Efficacy was evaluated based on the change on the Wrinkle Severity Rating Scale (WSRS) and the Global Aesthetic Improvement Scale (GAIS) from baseline. Results: At 12 and 24 weeks after treatment, the experimental group showed significantly greater improvement in mean WSRS score compared to the control group. And two (40%) of the five patients in the experimental group achieved ‘very much improved’ and two (40%) showed ‘much improved’ at 12 weeks after treatment. Conclusions: Intradermal RF treatment prior to HA filler injection may provide synergistic and long-lasting effects for the reduction of NLF wrinkles.

Confirmed efficacy of topical nifedipine in the treatment of facial wrinkles

Introduction: Over the past two decades, there has been increasing demand for aesthetic procedures to reverse the effects of aging, particularly in the facial area. Recently, topical nifedipine has been proposed for its anti-wrinkle efficacy. Objective: To confirm the anti-wrinkle efficacy of a 0.5% nifedipine-based topical formulation. Materials and methods: A randomized study was conducted in 20 healthy female volunteers, aged between 45 and 60 years, with moderate to moderately severe facial wrinkles. 10 volunteers applied a 0.5% nifedipine cream and 10 volunteers applied a good moisturizer twice daily for 90 days. The aesthetic improvement was evaluated by a blinded investigator using the Wrinkle Severity Rating Scale (WSRS). Anti-wrinkles effectiveness was also objectively assessed by measuring transepidermal water loss (TEWL), moisture levels of the stratum corneum, skin viscoelasticity and skin folding capacity by instrumental analysis. Results: Post-treatment WSRS score was significantly lower than the baseline WSRS score only in the nifedipine group. The mean WSRS score at T0 was 3.85 and at T3 1.84 in the nifedipine group, while the mean WSRS score at T0 was 3.78 and at T3 3.36 in the control group. Corneometry showed significant increases in measures of skin hydration and TEWL values decreased in all the patients of both groups, indicating a trend toward improved integrity of skin. Dermolab® recorded significant increases in measures of skin hydration in the nifedipine group and a lower increase in the control group. The colorimetric evaluation showed that use of the tested product resulted in significant overall lightening of the skin during use compared with baseline, while the moisturizer didn't produce any change of skin lightening parameters. Conclusion: The tested topical preparation is effective in reducing facial wrinkles' depth and in increasing skin hydration and elasticity.

A New Minimally Invasive Mesotherapy Technique for Facial Rejuvenation

IntroductionThis study describes a pivotal clinical trial of a new minimally invasive mesotherapy technique for facial rejuvenation.MethodsThe authors utilized two formulations: formulation A with hyaluronic acid, vitamins, amino acids, minerals, coenzymes, and antioxidant substances; formulation B with hyaluronic acid and idebenone. Fifty participants were enrolled in the study and divided in two groups. Group 1 (50–65 years) treated with formulation A. Group 2 (35–50 years) treated with formulation B. The groups underwent four sessions of mesotherapy involving multiple injections. Treatment was conducted at 15 day intervals. All participants had pre- and posttreatment photographs. Punch biopsies were taken from randomly selected participants, baseline and after 6 weeks, and stained for interleukin (IL)-6, IL-1β, matrix metalloproteinase (MMP)-1, and collagen 1. Clinical evaluation was based on the Global Aesthetic Scale (GAIS) and on the Wrinkle Severity Rating Scale (WSRS).ResultsThe results produced were statistically analyzed and resulted in a significant and long-lasting effect on facial rejuvenation. Evaluation of photographs at 0, 1, and 2 months revealed significant clinical improvement: brightness, texture, and firmness of the skin. The analysis of the GAIS and WSRS scores in the two groups demonstrated statistically significant results after 2 months. The biopsies taken from randomly selected participants at baseline and after 3 months showed a decrease in IL-1β, IL-6, and MMP1, and an increase in collagen 1.ConclusionThe new minimally invasive mesotherapy technique described can improve the clinical appearance of the skin in different age groups.

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.

Persistence of Nasolabial Fold Correction with a Hyaluronic Acid Dermal Filler with Retreatment: Results of an 18-Month Extension Study

An 18-month persistence study reported nasolabial fold (NLF) improvements using a small gel-particle hyaluronic acid (SGP-HA) dermal filler lasted up to 18 months after one retreatment. [corrected] To evaluate the efficacy and persistence of SGP-HA for the correction of NLFs for up to 36 months. Subjects completing the 18-month persistence study were permitted to enroll in an 18-month extension trial. Most required second retreatments to achieve optimal correction of their NLFs. Subjects were followed for up to 36 months after their initial treatment. The primary efficacy measure was a 1-point improvement from baseline Wrinkle Severity Rating Scale (WSRS) score as determined by a blinded evaluator at different time points. The study enrolled 52 subjects. Forty subjects required a second retreatment for optimum NLF correction. Mean retreatment volume was less than 50% of the initial treatment volume. Twenty-six subjects completed the study. Blinded assessments revealed that 94% to 100% of subjects maintained WSRS scores of 1 point or more higher than baseline throughout the study. Participants in the 18-month extension of an 18-month SGP-HA persistence study continued to demonstrate improvement of NLFs up to 36 months after a second retreatment. The mean volume of SGP-HA required for optimum NLF correction decreased substantially with each retreatment. Subjects reported no treatment-related adverse events after the second retreatment.

A Randomized, Evaluator-Blinded Comparison of Efficacy of Hyaluronic Acid Gel and Avian-Sourced Hylan B Plus Gel for Correction of Nasolabial Folds

BACKGROUND Five hyaluronic acid (HA)-based, biodegradable dermal fillers are approved by the U.S. Food and Drug Administration for the correction of moderate to severe facial wrinkles and folds. Because satisfactory initial correction can be obtained with all these agents, duration of cosmetic correction is an important distinguishing characteristic. OBJECTIVE The objective was to compare the efficacy and duration of treatment effects of HA gel and hylan B plus gel for the cosmetic correction of nasolabial folds. METHODS Fifteen patients with prominent nasolabial folds were randomized to treatment with HA gel and hylan B plus gel on contralateral sides of the face. Wrinkle severity and global aesthetic improvement were assessed by patients and a blinded evaluating investigator. Wrinkle Severity Rating Scale scores and Global Aesthetic Improvement Scale scores on both facial sides were assessed 2 weeks, 3 months, 4.5 months, and 6 months after treatment. RESULTS Wrinkle Severity Rating Scale scores and Global Aesthetic Improvement Scale scores were significantly higher for HA gel at 3, 4.5, and 6 months as assessed by both patients and evaluating investigator. CONCLUSION Both HA gel and hylan B plus gel provide dermal augmentation of nasolabial folds. The magnitude and duration of nasolabial fold correction appear to be greater for the HA gel than for the hylan B plus gel.