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Before and after pictures of patients treated with the new-generation PCL-based collagen stimulator.
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Background
The range of fillers currently available for soft-tissue augmentation is constantly expanding. The latest advances in filler technology include collagen biostimulators that exert their esthetic effect by promoting neocollagenesis. One such product is the next-generation collagen biostimulator (Ellansé®) that demonstrates properties as ye...
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The periocular area is one of the first regions of the body to show signs of aging, which include static and dynamic rhytids as well as subcutaneous volume loss. The complex anatomy and dynamic underlying muscles of facial expression make this region particularly difficult to treat. Botulinum toxins and fillers, especially when used in combination,...
Citations
... Unlike other polyester-based polymers, PCL is biodegradable. It is hydrolytically degradable to carbon dioxide and water [17][18][19]. Biomaterials produced from PCL are desired to be biocompatible, nontoxic and noncarcinogenic, chemically stable, and have sufficient mechanical strength. ...
Background
Injectable augmentation gels are widely used in the treatment of soft tissue. The composition of these gels has to be continuously improved due to the limitations of the currently available formulations.
Aims
This study focuses on the development of an innovative injectable gel designed to address current trends and specific needs within the field.
Methods
The current study utilized a safer hyaluronic acid (HA) gel carrier, created with a less toxic cross‐linker, in combination with polycaprolactone (PCL) microspheres at various concentrations. PCL microspheres were prepared using an emulsification‐solvent evaporation technique. Six different gel formulations were developed using PCL microspheres and biphasic HA gel structures.
Results
The produced microspheres had non‐agglomerated, smooth surfaces with an average particle size of approximately 45 ± 0.14 μm. The rheological results of the PCL‐HA6 such as storage modulus (G', Pa), loss modulus (G", Pa), complex viscosity (η*), and phase angle (°) at 1 Hz frequency were measured as 553.97 ± 32.48, 368.4 ± 12.24, 105.9 ± 5.27, and 33.65 ± 0.92, respectively, and the injection force was measured as 9.64 ± 1.46. In vitro tests revealed that the PCL‐HA6 group showed the highest cell viability compared to the other groups and provided a relative increase in collagen production over time, as demonstrated by the relevant gene expression.
Conclusions
The developed PCL/HA gel exhibited biocompatibility and non‐toxicity, making it a safe option for soft tissue augmentation. It demonstrated potential for medical applications and exhibited favorable rheological characteristics and injectability.
... Em conformidade com Melo et al. 10 Algumas limitações devem ser levadas em consideração na revisão integrativa da terapia de reposição hormonal com hormônios bioidênticos. Para começar, a maioria dos estudos analisados tem pequenas amostras e períodos de acompanhamento curtos. ...
Menopause brings a series of transformations to a woman's body due to hormonal changes that occur during this period, particularly affecting the skin by causing dryness, itching, wrinkles, and sagging. Currently, new aesthetic treatment options for the skin of menopausal women are emerging. Among them, bioidentical hormone replacement therapy, which involves the replacement of hormones with a molecular structure identical to those produced by the human body, and collagen biostimulators, which are injectable substances that stimulate the natural production of collagen in the skin, present themselves as a solution.This study is a integrative review aimed at identifying scientific evidence on the use of collagen biostimulators and bioidentical estrogen hormone replacement in increasing collagen in the skin of menopausal women. For the research, the platforms PubMed, ScienceDirect, and Google Scholar were used. The IBSP SS software was selected for the presentation of the descriptive analysis of the articles. Seventeen articles related to the topic were found. The conclusion is that there is not enough scientific evidence to prove the increase in neocollagenesis in the skin of menopausal women with collagen biostimulators and bioidentical estrogen hormone replacement.
... 11,12 Biostimulatory fillers consisting of poly-L lactic acid, polycaprolactone, polymethylmethacrylate, or calcium hydroxyapatite (CaHa) act by stimulating new collagen in the skin for gradual and long-term (up to 1-4 y) restoration of volume loss without an immediate lift effect. 7,11,[13][14][15][16] HA/CaHa (HArmonyCa; Allergan Aesthetics; an AbbVie company, Irvine, Calif.) is a hybrid injectable facial filler developed for aesthetic purposes that comprises a formulated matrix of HA gel crosslinked with CaHa microspheres to both provide immediate volume and lift and promote neocollagenesis for improved skin architecture and firmness. [17][18][19] Here, we provide an indepth review of the HA/CaHa hybrid injectable, including supporting preclinical and clinical data, with cases to illustrate product use recommendations and optimal treatment outcomes. ...
Background
HA/CaHa (HArmonyCa, Allergan Aesthetics, an AbbVie Company) is a hybrid injectable filler developed for aesthetic purposes that contains calcium hydroxyapatite microspheres suspended in a hyaluronic acid gel. This review describes preclinical and clinical data, recommendations for use based on the primary author’s clinical experience, and case studies that illustrate implementation of product use recommendations and patient outcomes.
Methods
Preclinical data on the lift capacity and tissue integration of the HA/CaHa hybrid injectable and clinical data on its safety, efficacy, and real-world use were extracted from poster presentations, published literature, manufacturer instructions for use, and proprietary data files. Case studies were presented based on clinical experience.
Results
The HA component of HA/CaHa provides an immediate and noticeable filling and lifting effect, whereas CaHa microspheres result in neocollagenesis. In preclinical studies, HA/CaHa demonstrated higher lift capacity ( P < 0.05) and faster tissue integration than a CaHa filler and led to collagen I gene and protein expression. Clinical studies showed clinical safety and effectiveness with high patient satisfaction. The most common adverse event was injection-site response. Clinician recommendations for achieving desired aesthetic results while minimizing or preventing adverse events are reviewed, including patient selection and assessment, treatment approaches based on face shape, injection technique, and postprocedure care.
Conclusion
The novel hybrid injectable consisting of HA with incorporated CaHa microspheres in a single marketed product may help achieve aesthetic goals by immediately restoring volume and potentially improving skin architecture and soft-tissue quality over time.
... More recently introduced to the market, collagen biostimulators are considered the latest generation of dermal fillers. Poly-L-lactic acid, calcium hydroxyapatite, and polycaprolactone (PCL) are biodegradable materials capable of stimulating new collagen synthesis [1][2][3]. ...
... Nevertheless, it is not advised to use it on the lip, glabella, or periorbital area. These regions have little subcutaneous fat, which increases the risk of product visibility and nodule formation [1,2]. At locations where PCL is injected, the most common early reactions are hematomas, erythema, edema, and ecchymosis. ...
... On the other hand, the quantity of the material decreased at 30 and 90 days, which can be attributed to the reabsorption of the CMC gel. In the initial weeks, the CMC gel is responsible for the immediate volumizing effect, and, over time, it is replaced by the tissue reaction induced by PCL [1][2][3][4][5][6][7]17]. ...
The objective of our study was to evaluate early and late macroscopic and histological changes associated with the use of polycaprolactone dermal filler (PCL) in the orofacial region. Forty-eight female Wistar rats were divided into the PCL group and the control group. The material was applied to the ventral tongue and submandibular region, and the animals were euthanized at three time points—24 h, and 30 and 90 days. In the PCL group, yellowish nodules were observed on the tongue at all experimental time points. At the 24 h mark, the histological analysis revealed the presence of the PCL and a predominance of lymphocytes, plasma cells, and neutrophils. At 30 and 90 days, macrophages and multinucleated giant cells predominated around the PCL spheres. Collagen density in the dermis was higher in the PCL group when compared to the control at 30 and 90 days. In the submandibular glands, an inflammatory process similar to that observed at other sites was noted, with no alterations in acinar or ductal morphology. The results of this study highlight the effectiveness of PCL as a collagen biostimulator. Nevertheless, the development of nodular lesions on the tongue signals the potential risk of complications in mobile anatomical structures.
... These characteristics make this biostimulator have a long-lasting effect for patients. 32,33 These gels are composed of PCL microspheres, from 25 to 50 μm in size, which are identified by phagocytic cells, thus inducing the formation of new collagen fibers around them, the volume being preserved even after they are phagocytized. These spheres are suspended in a carrier gel which is hydrolyzed by the body, forming CO 2 and water as a final product and is naturally and completely excreted. ...
... The main indications are volumization, contour improvement, rejuvenation, wrinkle and skin texture improvement. 32,33 In addition to the biostimulators mentioned above, which are used in a liquid suspension form, there are also biostimulators in solid state, such as the absorbable threads. Of these, the most used are polydioxanone (PDO) threads, but there are also threads made from other materials, such as PLLA and polycaprolactone. ...
Body Harmonization (BHA) is an innovative concept in aesthetics area based on a set of advanced injectable techniques that have shown promising results for body shaping. This is based on procedure combinations indicated to treat body aesthetic dysfunctions, such as localized fat, stretch marks, blemishes, flaccidity, buttocks remodeling, lean mass gain and muscle definition. This study aims to define the clinical concept of BHA, its applications and the main protocols used based on injectable pharmacotherapy. For this purpose, we performed a retrospective review of proven efficient injectable procedures with advanced results for the treatment of body aesthetic disorders, in addition to relying on data obtained from previous clinical experiences. Based on these data, we describe how different compounds can act for treatment of the main body aesthetic dysfunctions, such as lipolytic compounds and collagen biostimulators. In addition, the main application techniques and treatment protocols for each of these dysfunctions were defined. Minimally invasive injectable procedures offer an effective therapeutic option for patients who do not intend to undergo surgical interventions.
... O uso de alguns compostos para estimular a produção de colágeno aumentou exponencialmente nos últimos tempos. E essa prática vem crescendo ainda mais devido a alta eficácia e segurança, pelo curto desconforto no momento da aplicação, por serem procedimentos menos invasivos, o curto tempo de recuperação e, além disso, os menores custos do tratamento (Melo, 2017). ...
Cada vez mais, as pessoas buscam tratamentos para melhorar a aparência da pele, priorizando opções eficazes, de aplicação rápida e acessíveis em termos de custos. Os bioestimuladores de colágeno são conhecidos por sua capacidade de aumentar a firmeza, elasticidade e sustentação da pele, tornando-se uma escolha popular. O objetivo deste estudo é avaliar os efeitos desses produtos na pele com foco na redução do envelhecimento, foram considerados artigos científicos, dissertações, monografias e teses. Os bancos de dados utilizados foram Brasil Scientific Electronic Library Online (SciELO), Medical Literature Analysis and Retrieval System Online (MedLine) e Google Acadêmico. Os resultados ressaltaram a capacidade do colágeno em alcançar as camadas mais profundas da pele, promovendo firmeza e hidratação, atendendo às expectativas dos que procuram esses tratamentos. Diferentes produtos à base de colágeno mostraram eficácia na reversão do envelhecimento intrínseco e extrínseco, porém enfatizando a necessidade de uma avaliação por um profissional experiente e qualificado. Apesar de diversos benefícios foi possível observar a importância de mencionar que esses produtos podem gerar efeitos adversos, podendo ser imediatos, de médio ou longo prazo, sendo importante reforçar a necessidade de uma comunicação clara com o paciente. O farmacêutico passou a ser reconhecido para sua atuação na área da saúde estética, além de poder assumir a responsabilidade técnica de estabelecimento de saúde. Porém é importante frisar que toda atividade farmacêutica deve ser fundamentada no cumprimento das normas regulamentares que regem a profissão para garantir segurança aos usuários quanto aos procedimentos cabíveis e a eficácia dos recursos terapêuticos utilizados.
... Alguns bioestimuladores de colágeno, como o ácido poli-llático, podem ativar a cascata de sinalização envolvida na resposta inflamatória, promovendo a produção de moléculas sinalizadoras que estimulam a síntese de colágeno. (17)(18)(19)(20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30)(31)(32)(33)(34) Além disso, também atuam na ativação de vias metabólicas envolvidas na síntese proteica, aumentando a produção de colágeno de forma direta e eficaz 16,17 . ...
... A eficácia dos bioestimuladores também pode ser influenciada por fatores como idade, sexo, tipo de pele e hábitos de vida. É importante que os pacientes sejam orientados sobre cuidados com a pele e hábitos saudáveis para maximizar os resultados 27,28,33 . ...
A aparência da pele é de extrema importância entre o indivíduo e o meio externo, ela transmite características individuais e pessoais como a saúde, idade, emoções e essas características por vez, afeta bastante a autoestima. O envelhecimento cutâneo é classificado em dois tipos: intrínseco (cronológico) é o que ocorre com a passagem do tempo e é determinado principalmente for fatores genéticos, estado hormonal e reações metabólicas, ocorre naturalmente, com o passar do tempo as células do corpo perdem sua capacidade de renovação e cai rapidamente produção de fibras de colágeno e elastina que dão resistência e elasticidade aos tecidos do corpo , a segunda classificação é o tipo extrínseco, que é provocado pela exposição ao sol e fatores ambientais como estilo de vida (alimentação, exercícios físicos), tabagismo, alcoolismo e um dos mais importantes que é a radiação solar ultravioleta. Foi realizada uma revisão de literatura acerca de Bioestimuladores de colágeno a base de Polidioxanona, ácido Polilático, Hidroxipatita de Cálcio e Policaprolactona, usando como base de pesquisa as plataformas Pubmed (Publisher Medline), SciELO (Scientific Electronic Library Online), Google acadêmico e Núcleo do conhecimento, selecionamos artigos que diferenciam esses bioestimuladores e melhor indicação dos mesmos de acordo com a necessidade do paciente. O objetivo geral desse trabalho é apresentar a eficácia de cada um desses bioestimuladores de colágeno e sua colaboração na manutenção da saúde da pele, proporcionando firmeza e aspecto mais elástico, ajudando também a suavizar rugas, linhas de expressão e também preencher sulcos causados pela flacidez.
... O envelhecimento cutâneo pode ser intrínseco ou extrínseco. No primeiro caso se trata de um processo natural, para o qual não há remédio, porque não é uma doença [1] . No segundo caso, também pode não haver uma associação a um processo de morbidade, mas há associação com fatores extrínsecos àqueles genéticos, como o hábito de fumar, consumo de bebida alcoólica, exposição ao sol e outros aspectos relacionados aos hábitos de vida. ...
O Brasil está entre os países com maior volume de procedimentos estéticos realizados em todo o mundo. Entre os procedimentos existentes, está a realização de preenchimentos cutâneos para a melhora da aparência e redução de rugas e sulcos. O preenchimento é realizado, em geral, com bioestimuladores da produção de colágeno. O objetivo geral do presente artigo foi investigar a eficácia da hidroxiapatita de cálcio na produção de colágeno e melhora da aparência cutânea. Como metodologia, foi adotada a revisão integrativa de literatura, caracterizada pela busca por um número significativo de evidências científicas relacionadas a uma temática, de modo a orientar a prática clínica. Os resultados indicam que existem poucas pesquisas relacionadas à temática. Conclui-se que é necessária a produção de um número maior de estudos relacionado ao tema, os quais incluam amostras maiores, para que seja possível garantir a eficácia do tratamento em longo prazo ou mesmo uma eficácia mais significativa em comparação com outros tratamentos
... Although some biostimulators can be applied more superficially, PLLA, calcium hydroxyapatite undiluted or in hyaluronic acid, and polycaprolactone have a deeper application plan, either in the superficial fat compartment (subdermal or deeper) or even supraperiosteal. [19][20][21][22] For this reason, we also use ultrasound when performing injections in these planes. To perform ultrasound-guided facial injections, besides being able to perform aesthetic treatments, it is imperative that the injector have a broad knowledge of anatomy and ultrasound techniques. ...
The development of high-frequency devices and transducers in recent years has enabled the growth of the use of dermatologic ultrasound. Real-time monitoring of the anatomy of the face during the application of aesthetic injectables potentially prevents complications such as vascular occlusions. Injecting physicians starting out in the practice of ultrasound-guided injections are commonly faced with practical questions about its use. In this article, based on the experience with ultrasound-guided filler injections of 2 large clinical centers in 2 countries, the authors summarize the steps involved when setting out to use ultrasound to guide injectable aesthetic procedures, such as fillers and biostimulators. First, the authors discuss factors that guide the choice of equipment and ultrasound transducers to perform the procedures. Next, a detailed discussion on practical issues related to the procedure is provided. The authors then consider the positioning of operators and equipment in the treatment field. The authors conclude by suggesting 2 possible techniques to guide injectable procedures: (1) scan before injecting or (2) scan while injecting.
Level of Evidence: 5
... The particles induce type I and type III collagen as well as new soft tissue formation, resulting in long-lasting cosmetic correction, which may in some cases persist for well over 2 years. 4,5 The composition of the PCL-based filler comprises round smooth PCL microspheres (30% by volume) homogeneously suspended in aqueous carboxymethyl cellulose gel (70% by volume). A range of the PCL-based fillers are produced depending on the chain length (molecular weight) of the polymer and currently PCL-1 (Ellansé-S) and PCL-2 (Ellansé-M) are available as soft tissue fillers. ...
Background
The polycaprolactone-based filler, (PCL-1, Ellansé-S), forms part of the recently growing portfolio of biodegradable collagen-stimulating fillers. It is comprised of a suspension of 25–50 micron diameter microspheres of polycaprolactone (PCL) (30%) in a carboxymethyl cellulose (CMC) gel carrier (70%) and has gained popularity due to its long-term volumizing action.
Objective
This study outlines a retrospective case series of nine patients injected with the PCL-1, for volume augmentation in the mid-face. Objective volume calculations were performed with the Canfield Vectra 3D Imaging System at two time points post-implantation, with the objective of determining the longevity of the volumizing effect of the bio-stimulating substance.
Results
A clear increase in volume, between 50–150%, was found in all of the patients at two years, over and above the volume initially injected. All the patients were satisfied with the longevity of the results.
Discussion
The PCL-based filler is believed to afford immediate volume restoration due to the CMC gel component and a long-term action due to neo-collagenesis, induced by the PCL microspheres. The CMC gel is known to dissipate within 6–8 weeks, only to be replaced by new collagen induced by the PCL particles. Thus soft-tissue formation induced by the PCL particles, ultimately leads to a sustained volumizing effect.
Conclusion
The PCL-based filler is shown to have a sustained volumizing effects of at least 2 years duration with clear evidence of increase in volume over and above the volume injected, in all of the cases studied. This is indicative of significant neo-collagenesis induced by the PCL microspheres.
