ArticleLiterature Review

Review of Key Belotero Balance Safety and Efficacy Trials

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Abstract

Belotero Balance is a novel highly cross-linked hyaluronic acid that uses cohesive polydensified matrix technology to achieve cohesive gel; improved adaptation by the dermis; and a soft, smooth fill. Several studies have now compared Belotero Balance to bovine collagen and other hyaluronic acids. Two pivotal studies demonstrated the noninferiority and superiority of Belotero Balance to bovine collagen. In the first study, more than half of the patients maintained optimal correction at 6 months on the Belotero-treated side of the face. The second of those two studies followed patients to week 96 and demonstrated that the effects of Belotero Balance in this long-term, open-label study persisted in the majority of subjects without repeated treatment for at least one interval of 48 weeks. The filler was well tolerated, with only one of 34 total adverse events (injection-site bruising) considered to be related to the study device. A third study compared the safety and efficacy of other hyaluronic acids (i.e., Juvéderm and Restylane) with Belotero Balance. In this study, the safety profiles of all three hyaluronic acids were generally favorable, with site-specific adverse events mild to moderate and comparable across each hyaluronic acid. Aesthetic results were also similar, although Belotero Balance resulted in greater evenness than Restylane at 4 weeks by one indicator used in the study. Finally, a 5-year retrospective safety review of 317 patients treated with Belotero Balance over a 5-year period revealed no severe adverse events in any patients, including the absence of persistent nodules or granulomas.

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... It produces results comparable with those of other leading HA fillers with a similar duration of effect, and is well tolerated. [9][10][11] Treatment of the tear trough is one of the most challenging indications in facial rejuvenation. Appropriate patient selection and application of the correct injection technique is crucial for optimal cosmetic outcomes and tolerability. ...
... While individual results may vary, a number of studies with CPM HA gel in other facial indications show that in many patients the effects persist without repeat treatment for 12 months or longer. 10,11 In the current study, some subjects showed an incremental improvement from month 6 to month 9, which did not appear to be related to the amount of product injected or tear trough severity at baseline. Although follow-up ended at 9 months, it is possible that this effect persisted for longer. ...
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The tear trough or infraorbital hollow is a challenging area to treat, and only a few fillers are suitable for this delicate area. We report on a European case series of six subjects with mild to severe tear troughs who received treatment with cohesive polydensified matrix (CPM(®)) technology hyaluronic acid gel (Belotero(®) Balance). The product was injected as small depots (up to ten small boli 0.2 mL maximum each per side) at the supraperiosteal level along or below the orbital rim. Follow-up visits took place at 1, 3, 6, and 9 months after injection for independent evaluation of the clinical effect using the Merz Aesthetics Scale™ for infraorbital hollows and the Global Aesthetic Improvement Scale. Adverse events were also recorded. Mean hollowness scores were considerably improved compared with baseline in all subjects. In all women, the improvements remained throughout the 9-month study, with none reverting to their baseline score. Subjects' satisfaction with treatment was very high throughout the study, and all women stated that they would repeat treatment with the same product. The CPM hyaluronic acid gel was well tolerated. CPM hyaluronic acid gel is a safe and effective treatment for the tear trough area.
... PMMA has been used extensively in dental and orthopedic surgical settings, largely as a biocompatible cement [1,74]. The ultimate goal in treating deep skin creases is to expand dermal layer volume and simultaneously replace dermal collagen [56]. In Artecoll, bovine collagen functions as a transient carrier of PMMA microspheres, and facilitates their deposition in tissue. ...
... The pivotal studies indicated of the patients maintained optimal correction at 6 months on the Belotero-treated side of the face. The open-label study of dermal fillers persisted in the majority of subjects without repeated treatment [56]. ...
Chapter
In order to develop and commercialize for the regenerative medicinal products, smart biomaterials with biocompatibility must be needed. In this chapter, we introduce collagen and hyaluronic acid (HA) as extracellular matrix as well as deal with the molecular mechanism as microenvironment, mechanistic effects, and gene expression. Application of collagen and HA have been reviewed in the area of orthopedics, orthopedics, ophthalmology, dermatology and plastic surgery. Finally, the ongoing and commercial products of collagen and HA for regenerative medicine have been introduced.
... Although the more diffuse distribution of Belotero Ò still needs to be correlated with clinical outcomes, Belotero Ò has a lower G prime value (the technical ''hardness'' of the gel) than other HA formulations, which makes it useful for injection into fine lines. Also, it has low viscosity, which allows it to be injected easily and spread into surrounding tissues [51,52]. Both characteristics, added to the fact that the unwanted Tyndall effect has not been reported with Belotero Ò Balance, makes the product an excellent option to treat tear trough deformity. ...
... Some injectors add a varying amount (typically 0.1-0.3 cc) of 1 % lidocaine, with or without epinephrine, to Belotero Ò for increased patient comfort, although this is considered off-label and may dilute the product, and injectors may note that it takes extra force to push the reconstituted product through the needle [51,53]. ...
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Injection of dermal fillers is the second most frequent nonsurgical cosmetic procedure performed in the USA. Dermal fillers are an option in the treatment of volume deficiency, scars, and rhytides; facial sculpting; facial contouring; and augmentation of specific anatomical sites such as the lips. The number of injectable dermal fillers available on the market increases yearly. Dermatologists and cosmetic surgeons should regularly review treatment options to provide patients with safe and effective filler options. This paper extensively reviews the properties of the available fillers, such as their rheology, longevity, and adverse effects, and how these properties affect the choice of filler agent for a particular patient or a particular site. Also, trends in dermal filler injections are discussed.
... Interest in noninvasive and minimally invasive methods to model and to correct facial wrinkles has increased worldwide in the last few decades, such that they now comprise >80% of all esthetic interventions, compared with <50% in the 1990s. 1 Dermal fillers are a common minimally invasive option for the nonpermanent treatment of age-related facial wrinkles, nasolabial folds (NLF), marionette lines, and cheek hollowness. 2 Among the biodegradable filler products currently available, hyaluronic acid (HA) fillers are used most often because of their good performance and favorable safety profile. 1 HA fillers with various degrees of cross-linking are highly elastic and viscous compared with noncross-linked HA and are thus very suitable as biologically compatible fillers for the treatment of lines and wrinkles. These fillers have been used successfully for many years for the temporary correction of facial wrinkles and folds, such as NLF. ...
Article
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Ulrich Kühne,1 Jørgen Esmann,2 Dennis von Heimburg,3 Matthias Imhof,1 Petra Weissenberger,4 Gerhard Sattler,5 On behalf of the BALIA Study Group 1Aesthetische Dermatologie im Medico Palais, Bad Soden, Germany; 2Jørgen Esmann Aps, Hellerup, Denmark; 3Praxisklinik Kaiserplatz, Frankfurt am Main, Germany; 4Corporate Clinical Research, Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany; 5Rosenparkklinik GmbH, Darmstadt, Germany Abstract: Cohesive polydensified matrix (CPM®) hyaluronic acid fillers are now available with or without lidocaine. The aim of this study was to investigate the safety and performance of CPM® fillers with lidocaine in the clinical setting. In an open-label, prospective, postmarketing study, 108 patients from seven sites in Germany and Denmark were treated with one or more lidocaine-containing CPM® fillers. Performance was assessed using the Merz Aesthetics Scales® (MAS). Pain was rated on an 11-point visual analog scale. Patients’ and physicians’ satisfaction as well as adverse events were recorded. Improvements of ≥1-point on MAS immediately after and 17 days posttreatment were observed in ~90% of patients compared with baseline. All investigators assessed ejection force, product positioning, and performance as similar or superior to the respective nonlidocaine products. Overall, 94% of investigators were satisfied with the esthetic outcomes and were willing to continue using the products. All patients except one were satisfied with the results, and all were willing to repeat the treatment. Mean pain scores were low during (<3.0) and after injection (<0.6). Except for one case of bruising, all adverse events were mild to moderate. CPM® fillers with lidocaine are safe and effective for a wide range of esthetic facial indications. Keywords: cohesive polydensified matrix, dermal fillers, Belotero, Esthélis, Fortélis, Modélis
... It is formulated by patented technology called Cohesive Polydensified Matrix. This process uses a second cross-linking stage with the addition of non-cross-linked HA. 18 Cross-linking is variable with a higher content of non-cross-linked HA. This produces a highly cohesive, yet smooth product. ...
Article
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Soft-tissue filler use has grown considerably related to the increasing popularity of minimally invasive cosmetic procedures. Hyaluronic acid products are currently the most utilized soft-tissue fillers. Proper working knowledge of individual products, limitations to use, and anatomic principles can improve outcomes. Prevention is key to minimize complications; however, when present, complications must be managed methodically. Complications are categorized based on the timing of presentation and include early, late, and delayed. Vascular compromise and tissue necrosis are among the most devastating complications seen with filler use. Nodules can be related to an inflammatory or infectious etiology but should be distinguished as treatment varies. Hyaluronidase is mandatory to have available as a reversal agent for hyaluronic acid products and can be used in treatment for many complications and untoward sequela.
... 4,5 Cumulative improvements in esthetic outcomes were observed with the administration of each agent. 7,8 These findings demonstrate the importance of layering with agents of distinctive properties to achieve the desired outcomes, which could not be achieved by monotherapy. ...
Article
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A 3-dimensional, multi-layered approach combining modalities targeting different manifestations is recommended for achieving optimal esthetic outcomes. To date, studies reporting same-day treatment with dermal fillers and botulinum toxin have not been published. This article documents the practical use of a single-visit, pan-facial multimodal approach in addressing the varying esthetic needs of 8 Asian adults. The case series included male or female patients of varying age and degrees of facial fat, who received combination treatment with calcium hydroxylapatite filler, polydensified hyaluronic acid filler, and incobotulinumtoxin A in a single visit in August 2016 at a treatment center in Taiwan. Treatments were individualized based on the needs of each patient, according to guideline recommendations. The agents, with distinctive rheological properties indicated for different purposes, were applied sequentially across different facial tissue planes within a single visit. Patients were monitored for development of side effects after treatment. Photographs taken before treatment and 2 weeks after treatment were evaluated by the treating physicians. For all patients, treatment produced substantial improvements in all treated facial areas. Inherent morphological deficiencies in younger patients were addressed, age-related changes in older patients were corrected, and facial sexual dimorphism was enhanced in male and female patients. No major side effects occurred after treatment. This case series showcases the real-life implementation of a flexible, single-visit, multimodal approach that can be adapted for a variety of indications.
... In recent years, injectable dermal fillers have challenged the use of more invasive esthetic surgical procedures, emerging into the armamentarium of products used by physicians in the treatment of the signs of aging (Brandt & Cazzaniga, 2008;Carruthers et al., 2009;Palm, 2014). The most commonly used dermal filler is hyaluronic acid (HA) (Lorenc et al., 2013). More than 1.6 million HA filler procedures were performed in 2014 in the USA, making it the second most commonly used nonsurgical esthetic procedure after botulinum toxin. ...
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Abstract Background Injectable dermal fillers are commonly used by physicians in the treatment of the signs of aging. The most commonly used dermal filler is hyaluronic acid. Skinfill plus (SFP) belongs to the family of monophasic monodensified fillers. In this post-marketing clinical study, we have evaluated the efficacy of SFP for the treatment of facial aging. Methods The study enrolled 109 patients in three different centers that were treated with various SFP fillers to treat facial aging. Analyses of the cosmetic effects were performed by using the Wrinkle Severity Rating Scale (WSRS) and the Global Aesthetic Improvement Scale (GAIS). Results Statistical analysis showed a significant effect on facial aging for all the SFP fillers used at all time-points studied. Moreover, a significant correlation was found, by analyzing the grade of facial aging, calculated by using the WSRS or the lifestyle of the patients (smokers or non-smokers) in relation to the cosmetic effects of the treatment. Conclusions The study confirms the good performance and safety of SFP for a range of facial indications in routine clinical practice.
... 6 The most commonly used dermal filler is hyaluronic acid (HA). 7 According to the statistics of the American Society for Aesthetic Plastic Surgery, >1.6 million HA filler procedures were performed in 2014 in the US, making it the second most frequently used nonsurgical esthetic procedure after botulinum toxin. ...
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Utilizing a soft-tissue filler that is more fluid and less resistant to deformation may be advantageous for correction of infraorbital hollows. OBJECTIVE: The objective of this study was to determine the safety and efficacy of the latest hyaluronic acid filler, created with a cohesive polydensified matrix, with a low elasticity and viscosity, for infraorbital hollows correction. METHODS AND MATERIALS: Subjects (49) with at least a grade 2 Merz infraorbital hollow scale in the Validated Assessment Scales for the mid face (0-4) of the right and/or left side were photographed and treated at baseline, and with a touch up treatment after 2 weeks if necessary. Subjects were also photographed at 2, 6, and 10 months after baseline, with optional retreatment at 6 months. The photographs were graded by a blinded sub-investigator. RESULTS: Mean hollowness scores for both eyes, either individually or combined, at 2, 6, and 10 months were considerably improved compared to baseline ( P <.001). No serious adverse events were reported. Of the 46 subjects completing the study, 31 (66%) did not request retreatment after 6 months. At 10 months, 27/31 (87%) still exhibited a hollowness improvement of at least 1-point from baseline. CONCLUSION: Belotero Balance was safe and effective for the correction of infraorbital hollows. J Drugs Dermatol. 2014;13(9):1030-1036.
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Many patients seeking rejuvenation treatment have readily apparent age-related changes in facial features. Others exhibit more subtle changes that nonetheless can be corrected to achieve a more youthful appearance. In the following article, four specialists in aesthetic dermatology discuss how injectable hyaluronic acid-based fillers and neurotoxins can achieve rejuvenation without surgery.
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Hyaluronic acids (HAs) have become the injectable filling agents of choice due to both their biocompatibility and ability to be enzymatically dissolved with hyaluronidase. Recent trends in facial analysis have resulted in injectors assessing the face in three dimensions and combining or layering different injectable products during the same treatment session. Quality of life measures confirm that patients are satisfied with the volume enhancements and facial rejuvenation they receive after injections. Increased understanding of the biophysics of HAs allows not only improved understanding of how the products act in vivo, but also allows for the manufacture of products with varying physical characteristics. Although the safety and efficacy of these products have previously been established in the scientific literature, recent studies describe both acute and chronic complications seen with these agents. In the future, HAs may be combined with tissue-engineered fibroblasts, which could improve the safety and longevity of these products.
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A retrospective observational case study and a literature review were conducted to evaluate how anatomic findings, especially those related to the periorbital zone, serve as a guiding compass for injectable implants. Treatment techniques and product selection will be discussed for patients with negative vector, shallow orbit, and deep set eyes. Versatility of injectables will be demonstrated on patients with peanut face, iatrogenically altered anatomy (after surgery), and trauma.
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Filler auf der Basis von Hyaluronsäure (HA-Filler) sind die am häufigsten verwendeten „Soft-Tissue-Filler“. Sie haben im Vergleich zu anderen Fillern ein vorteilhaftes Nutzen-Risiko-Verhältnis und können im Falle unerwünschter Nebenwirkungen durch eine Hyaluronidase-Injektion weitestgehend „aufgelöst“ werden. Das anatomische Injektionsareal und die Gewebebeschaffenheit sind maßgeblich für die Auswahl des richtigen Fillers. Grundsätzlich sind Produkte mit einer geringeren Quervernetzung für feine Fältchen geeignet, die visköseren Produkte mit einer höheren Hebekapazität für tiefere Falten, aber auch zur Gesichtskonturierung und für die Formung anatomischer Gesichtsregionen sowie zur Therapie alterungsbedingter Volumenverluste. Profunde anatomische Grundkenntnisse der Gesichtsregion und deren Alterungsprozesse, die geeignete Patientenauswahl, sichere HA-Filler, weitreichende Erfahrung in den Injektionstechniken und umfassendes Wissen in der Vorbeugung und Behandlung von möglichen Komplikationen sind essenzielle Grundvoraussetzungen dieses komplexen Therapieverfahrens.
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Filler auf der Basis von Hyaluronsäure (HA-Filler) sind die am häufigsten verwendeten „Soft-Tissue-Filler“. Profunde anatomische Grundkenntnisse der Gesichtsregion und deren Alterungsprozesse, die geeignete Patientenauswahl, sichere HA-Filler, weitreichende Erfahrung in den Injektionstechniken und umfassendes Wissen in der Vorbeugung und Behandlung von möglichen Komplikationen sind essenzielle Grundvoraussetzungen dieses komplexen Therapieverfahrens.
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Chapter
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There are numerous dermal fillers available to injectors in the US and Europe for the correction of age-related volume loss in the midface and perioral regions. Product availability differs between these two aesthetic markets due to US Food and Drug Administration (FDA) regulatory requirements. The purpose of this study is to discuss differences in filler selection by two practitioners in the US and Europe based upon both stylistic approach and filler availability in each market. To analyse and discuss the approach to midface as well as lip and perioral volume restoration by two independent dermatologists working in the US and Italy. Seven patients were selected for discussion and divided into two groups: 1) those requiring midface volumization and 2) those undergoing perioral or lip volume replacement. Patients in the midface group were injected with Juvéderm Voluma® XC, Juvéderm® Volift® with lidocaine, Restylane- L®, Perlane-L® or Radiesse®. Patients in the perioral and/or lip group were injected with Juvéderm® Volbella™, with lidocaine, or Belotero Balance™. Patients were photographed before and immediately after injection to evaluate aesthetic outcomes. In each case, filler selection was based upon patient characteristics, anatomical considerations and inherent filler properties. Results: All patients were extremely satisfied with their treatments. There were no significant immediate or delayed complications following treatment with any of the dermal fillers used. Volume restoration in the midface and perioral or lip region can be effectively achieved using a variety of dermal fillers. The dermal filler portfolio available in Europe is exponentially larger than that in the US. Product selection in either market is ultimately the result of the physician's experience injecting each dermal filler, as well as his or her personal preferences. J Drugs Dermatol. 2014;13(1):67-74.
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A high concentration of crosslinked hyaluronic acid (HA) in a smooth, malleable formulation is the hallmark of the new Juvéderm dermal fillers. To determine the long-term effectiveness and safety of Juvéderm Ultra and Ultra Plus injectable gel. In the multicenter study approved by the Food and Drug Administration, subjects were randomized to treatment with Juvéderm Ultra or Ultra Plus in one nasolabial fold (NLF) and Zyplast collagen in the other. After optimal correction was achieved (treatment plus up to 2 touch-ups at 2-week intervals), effectiveness was assessed on a 5-point scale through the 6-month study period. An additional poststudy visit provided long-term effectiveness data. Safety was evaluated through subjects' daily diaries for 14 days after treatment. A total of 292 subjects were randomized and treated, 146 in each cohort. A total of 280 subjects completed the 6-month study, and 227 attended the poststudy visit. Clinically significant mean wrinkle correction (>or= 1 point improvement) was still in evidence at >9 months for both Juvéderm formulations but not for the Zyplast control. At >9 months, 75% of Juvéderm Ultra- and 81% of Juvéderm Ultra Plus-treated NLFs maintained a clinically significant correction. Moreover, 78% of NLFs treated with Juvéderm Ultra Plus still had a clinically significant improvement beyond 1 year. Local treatment site reactions were comparable for Juvéderm and Zyplast. These next-generation HA dermal fillers can be reliably expected to provide long-term correction, with Juvéderm Ultra lasting more than 9 months and Juvéderm Ultra Plus lasting for a year or more.
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A new family of next-generation non-animal hyaluronic acid (HA) dermal fillers was approved by the FDA in June 2006. Compared with other HA fillers available in the United States at the time of writing, these new fillers have a higher concentration of HA, higher concentration of cross-linked HA, and a smooth consistency--which should promote long-lasting corrections and a smooth, natural look and feel postinjection. The objective was to compare the effectiveness and safety of these smooth-gel HA dermal fillers with bovine collagen for nasolabial fold (NLF) correction. A total of 439 subjects with moderate or severe NLFs received one of three types of smooth-gel HA dermal filler (in one NLF) and cross-linked bovine collagen (in the other NLF) and were evaluated for <or=24 weeks. All three HA dermal fillers achieved considerably longer-lasting clinical correction than bovine collagen; 81% to 90% of HA dermal filler-treated NLFs maintained a clinically significant improvement from baseline for >or=6 months. Up to 88% of subjects preferred the HA dermal fillers over bovine collagen. All fillers were similarly well tolerated. The smooth-gel HA dermal fillers offer longer-lasting correction than bovine collagen-which may lessen the frequency that repeat treatments are needed. Also, they were preferred by the vast majority of subjects-which should promote patient satisfaction.
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Although the use of the hyaluronic acid with cohesive polydensified matrix hyaluronic acid has been well explored in subjects with lighter skin (i.e., Fitzpatrick skin types I, II, and III), further exploration in subjects with Fitzpatrick skin types IV, V, and IV is warranted. The primary purpose of the study was to assess the safety of a cohesive polydensified matrix hyaluronic acid in the correction of nasolabial folds in subjects with Fitzpatrick skin types IV, V and VI, especially assessment of hyperpigmentation, hypopigmentation, and scarring. Effectiveness was also assessed. A total of 93 subjects were enrolled in this 24-week investigation at three sites in the United States. All were injected bilaterally for nasolabial fold correction with cohesive polydensified matrix hyaluronic acid. Assessments included the recording of adverse events; injected volumes; wrinkle severity ratings; and global aesthetic improvement by evaluating investigators, treating investigators, and study subjects. Injection of cohesive polydensified matrix hyaluronic acid for the treatment of nasolabial folds in subjects with Fitzpatrick skin types IV, V, and VI showed no evidence of an association with hypopigmentation, hyperpigmentation, or scarring. Adverse events reported were typical of dermal filler injections with respect to type, rate, duration, and severity. Cohesive polydensified matrix hyaluronic acid is a safe and well-tolerated dermal filler for subjects with Fitzpatrick skin types IV, V, and VI.
Article
Background: Hyaluronic acids (HA) fillers abound in the European community, many with different names in different countries. One such HA is Belotero Basic, recently approved by the FDA in the United States. Objective: The objective of this article is to report on use of this HA in a German clinic, over a period of 5+ years, in 317 patients (668 treatments). Methods and materials: Authors retrospectively examined patient charts of 317 patients (312 females), aged 24 to 87 years. Chart review showed areas treated, range of volumes per area, and mean volumes. Patient satisfaction data was collected anecdotally over the five years. Results: Volumes of the HA injected ranged from 0.2 mL to 3.0 mL, depending on the area being treated. No serious adverse events were noted in the chart review, nor was any Tyndall effect observed in the treated areas. Anecdotal information suggests high patient satisfaction with results, based on the return of these patients to the clinic for other treatments over the more than five years. Conclusion: Belotero Basic provides aesthetically pleasing results for treatment of facial defects, without carrying a risk of serious adverse events. North American physicians now have a new HA to consider as part of their treatment protocols.
Article
BACKGROUND Dermal fillers are used to augment wrinkles and folds, and a variety of hyaluronic acid (HA)-based products are available. The non-animal-sourced HA studied was cross-linked using a two-step process and employing cohesive polydensified matrix (CPM) technology. This HA gel (CPMHA) has variable density and viscosity zones for adaptation in the dermis.OBJECTIVE To compare the safety and effectiveness of CPMHA with that of bovine collagen (COL) in the correction of moderate to severe nasolabial folds (NLFs) in a split-face study.METHODS AND MATERIALS One hundred eighteen subjects were randomized to receive CPMHA and COL on contralateral sides of the face. NLF severity was measured using the Wrinkle Severity Rating Scale (WSRS). The initial treatment was evaluated after 2 weeks, and an optional touch-up to optimal cosmetic correction was permitted if needed. Subjects returned every 2 weeks (up to 24 weeks) for evaluation. Safety was assessed using spontaneous adverse event (AE) reporting.RESULTS CPMHA resulted in a significantly greater reduction in the mean change of WSRS than COL at weeks 8 (p=.009), 12 (p<.001), 16 (p<.001), and 24 (p<.001). There were no significant differences between the two groups in the proportion of AEs considered related to the injection site procedure. Most AEs were mild to moderate in severity and resolved within 7 days.CONCLUSION CPMHA was well tolerated and first demonstrated to be noninferior and then superior in terms of effectiveness to COL over 24 weeks for the treatment of NLF, including the primary end point at week 12.Merz Pharmaceuticals, LLC funded this Food and Drug Administration clinical trial. Bhushan Hardas, Mandeep Kaur, Starr Grundy, and Eric Pappert are employees of Merz Pharmaceuticals.
Article
Data regarding several hyaluronic acids (HAs) used identically for facial tissue augmentation have heretofore been unavailable. This prospective, split-face, randomized, two-armed study sought to determine the long-term safety and effectiveness of three HAs (HA-1 (Belotero Basic/Balance), HA-2 (Restylane), and HA-3 (Juvéderm Ultra 3/Juvéderm Ultra Plus XC) in the treatment of nasolabial folds (NLFs). Twenty participants in Arm A received HA-1 in one NLF and HA-2 in the other. In Arm B, 20 participants received HA-1 in one NLF and HA-3 in the other. Injection was at visit 2, with follow-up visits at 1, 6, 9, and 12 months. Mean volume of HA was slightly <1.5 mL/NLF. Adverse events were unremarkable across all HAs, with injection site erythema being the most frequent adverse event. Mean pretreatment NLF severity rating for both arms was 2.3; at 12 months, mean posttreatment severity rating was 1.5 for HA-1/HA-2 and 1.6 for HA-1/HA-3. Although not statistically significant, participants tended to show a preference for HA-1. All three HAs provided essentially equivalent results, except for 4-week evenness results, which favored HA-1. Injection volumes of the three HAs were also similar.
Article
Repeat treatments of nonpermanent dermal fillers are used in the long-term treatment of wrinkles and folds and to volumize. OBJECTIVE To determine the safety and effectiveness of a nonanimal-sourced hyaluronic acid (HA) (which uses a cohesive polydensified matrix (CPM) technology [CPMHA]) for the treatment of nasolabial folds (NLFs) during an 18-month open-label extension trial. Ninety-five of 118 subjects continued with this optional open-label extension of a split-face, double-blind trial. All subjects received CPMHA in both NLFs at 24 weeks after treatment in this study and were assessed at weeks 32, 48, 72, and 96. Touch-ups were allowed for optimal correction. Safety was assessed according to reported adverse events (AEs) and serum antibody measurement. At all four post-week 24 time points, the severity of the NLFs showed a decrease from baseline on the Wrinkle Severity Rating Scale. The effects persisted in the majority (∼80%) of subjects without repeat treatment for at least one interval of 48 weeks. The study filler was well tolerated, with only one related AE (injection site bruising) reported. Little potential for immunogenic reactions was identified. This CPMHA is a well-tolerated and effective treatment for at least 48 weeks in the majority of subjects for the correction of moderate to severe NLFs with repeat injections given over an 18-month period.
Article
Hyaluronic acid (HA) fillers are becoming the material of choice for use in cosmetic soft tissue and dermal correction. HA fillers appear to be similar, but their physical characteristics can be quite different. These differences have the potential to affect the ability of the physician to provide the patient with a natural and enduring result. The objective of this article is to discuss the key physical properties and methods used in characterizing dermal fillers. These methods were then used to analyze several well-known commercially available fillers. Analytical methods were employed to generate data on the properties of various fillers. The measured physical properties were concentration, gel-to-fluid ratio, HA gel concentration, degree of HA modification, percentage of cross-linking, swelling, modulus, and particle size. The results demonstrated that commercial fillers exhibit a wide variety of properties. Combining the objective factors that influence filler performance with clinical experience will provide the patient with the optimal product for achieving the best cosmetic result. A careful review of these gel characteristics is essential in determining filler selection, performance, and patient expectations.
Article
Bovine collagen is widely used as a dermal filler for facial soft-tissue augmentation, but it provides only temporary cosmetic improvement. Nonanimal stabilized hyaluronic acid has reduced potential for immunogenicity and hypersensitivity and may provide a more durable aesthetic result. Sixty-eight patients with prominent nasolabial folds were randomized to intradermal treatment with nonanimal stabilized hyaluronic acid gel (Perlane) and bovine collagen (Zyplast) on contralateral sides of the face. On achievement of "optimal cosmetic result" (baseline), patients were followed up for 6 months; bilateral retreatment with Perlane was offered at 6 or 9 months after baseline. Responses were evaluated at 2, 4, 6, 9, and 12 months after baseline. Investigator-based and patient-based ratings indicated that Perlane was more effective than Zyplast in maintaining cosmetic correction. According to investigator-based Wrinkle Severity Rating Scale assessments at 6 and 9 months after baseline, Perlane was superior in 50.0 percent and 48.8 percent of patients, respectively, whereas Zyplast was superior in 10.3 percent and 14.0 percent of patients, respectively (p < 0.0004). Investigator-based Global Aesthetic Improvement Scale assessment at 9 months after baseline indicated that Perlane was superior in 48.8 percent of patients, whereas Zyplast was superior in 14.0 percent of patients (p = 0.0025). "Optimal cosmetic result" was achieved with a smaller volume of Perlane than Zyplast (mean, 1.2 ml versus 2.1 ml). Local injection-site reactions (redness, swelling, pruritus, and induration) were less frequent with Perlane than with Zyplast. Delayed-onset reactions were rare and did not reoccur after Perlane retreatment. Perlane has acceptable long-term safety and offers a longer-lasting aesthetic improvement than Zyplast.