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Introduction: Enlarged facial pores are a common cosmetic concern caused by excessive sebum production, visible hair shafts, and a reduction in skin elasticity, leading to a decrease in skin quality and overall appearance. Various treatment modalities have been explored to address this issue. This study focuses on the efficacy and safety of combining Onabotulinumtoxin A (OnaBoNT-A) and hyaluronic acid filler (HA filler) to target enlarged facial pores in Asians. Materials and Methods: This study aimed to compare the efficacy and safety of OnaBoNT-A monotherapy in combination with HA filler for the treatment of enlarged facial pores. This study was a prospective, randomized, single-blinded, split-face, controlled trial that enrolled 32 subjects with visibly enlarged pores on both cheeks. One side of the face received intradermal injections of OnaBoNT-A, while the other side received OnaBoNT-A in combination with intradermal hyaluronic acid filler injection. The outcomes were measured by pore volume, visual assessment, pain score, improvement score, and side effects at various time intervals up to 24 weeks. Results: This study investigated the effects of onaBoNT-A monotherapy or in combination with HA filler on facial pore size and skin roughness. The results showed that both sides exhibited a reduction in pore volume and skin roughness over time, but the side treated with onaBoNT-A monotherapy had a slightly better improvement than the combination side at the 6-month follow-up. Subjects with histories of facial oiliness were more likely to respond to onaBoNT-A monotherapy, while those without histories of facial oiliness were more likely to respond to the side treated with combined treatment. The most common adverse events were erythema, bruising, and edema, which were more frequent on the combination side. Additionally, 18 subjects (56.25%) experienced a palpable lump on the combination side, which resolved in most cases within a few months. Conclusion: BoNT-A and HA dermal filler had a role in reducing pore size. Nonetheless, individuals with enlarged pores who exhibited beneficial effects to botulinum toxin injection typically had a background of facial oiliness. Adverse incidents like dermal edema and palpable nodules were observed, underscoring the significance of meticulous patient selection and accurate injection technique.

Background Hyaluronic acid (HA) is a widely used dermal filler for lip augmentation. IPN-20-SENSE LIDOCAINE (Laboratoires VIVACY) is a monophasic gel consisting of cross-linked HA and includes lidocaine hydrochloride for the reduction of injection-associated pain. Aims The SMILE study was designed to assess the non-inferiority of IPN-20-SENSE LIDOCAINE compared to HA-RK-Lido in improving aesthetic lip appearance. The secondary objectives were to evaluate the effectiveness and safety of IPN-20-SENSE LIDOCAINE against the chosen similar active control device. Patients/Methods This was a prospective, multicenter, double-blinded, randomized active controlled parallel group study undertaken in two investigational sites between May 2021 and July 2022 (14 months). The primary endpoint of this study was the proportion of subjects reporting an improvement on the Global Aesthetic Improvement Scale (GAIS) 3 months after treatment initiation. Results Regarding the primary endpoint, the difference between the treatment arms in the proportion of improved subjects was +7.0 [-2.2; 17.7]. The lower limit of this 90% CI, being above the non-inferiority margin of -15 and below zero, demonstrated the non-inferiority of IPN-20-SENSE LIDOCAINE vs. HA-RK-Lido. The secondary outcomes reported by subjects and the blinded live evaluators supported this result. All injection site reactions and device-related adverse events reported in this study were expected, already described and were mostly mild and transient. Conclusions The study demonstrated the non-inferiority of IPN-20-SENSE LIDOCAINE to HA-RK-Lido in the aesthetic improvement of the lips. The effect of both treatments decreased over time. Nonetheless, aesthetic improvement was sustained longer in the IPN-20-SENSE LIDOCAINE arm. Level of Evidence I This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Background Although manufacturers of 1,4‐butanediol diglycidyl ether (BDDE)‐cross‐linked hyaluronic acid (HA) fillers assert effective removal of unreacted BDDE, the hydrolyzed derivative 3,3′‐(butane‐1,4‐diyl)bis(oxy)bis(propane‐1,2‐diol) (BDPE) is routinely monitored, despite possessing structural features associated with sensitization potential. Aims To quantify free BDPE content across commercially available HA dermal fillers and assess potential safety implications. Materials/Methods A validated liquid chromatography–tandem mass spectrometry method was developed to quantify BDPE levels in 38 commercial HA filler products from seven major manufacturers. In silico prediction models were used to evaluate the skin sensitization and irritation potential of BDPE. Results BDDE levels were non‐detectable in all analyzed products. By contrast, free BDPE content varied markedly, with over 1000‐fold differences observed between products, indicating substantial variability in purification efficiency across manufacturing processes. Considerable variability was also identified among Food and Drug Administration–approved products, with some containing BDPE concentrations exceeding 100 ppm. Conversely, several products exhibited low BDPE levels ranging from 0.1 to 2.5 ppm, further highlighting inconsistencies in manufacturing control. Conclusions Industry claims regarding complete cross‐linker removal may fail to account for the persistence of BDPE species. The substantial inter‐product variability observed in this study suggests inadequate process control among manufacturers. Given the structural similarity of BDPE to known sensitizers and the direct dermal injection route that circumvents the skin barrier, free BDPE should be designated a critical quality attribute with defined acceptance limits. These findings suggest that BDPE can be reduced to concentrations below 2.5 ppm, supporting the need for stricter manufacturing standards.

BackgroundDermal fillers have been increasingly used in minimally invasive facial esthetic procedures. This widespread use has led to a rise in reports of associated complications. The aim of this expert consensus report is to describe potential adverse events associated with dermal fillers and to provide guidance on their treatment and avoidance.MethodsA multidisciplinary group of experts in esthetic treatments convened to discuss the management of the complications associated with dermal fillers use. A search was performed for English, French, and Spanish language articles in MEDLINE, the Cochrane Database, and Google Scholar using the search terms “complications” OR “soft filler complications” OR “injectable complications” AND “dermal fillers” AND “Therapy”. An initial document was drafted by the Coordinating Committee, and it was reviewed and modified by the experts, until a final text was agreed upon and validated.ResultsThe panel addressed consensus recommendations about the classification of filler complications according to the time of onset and about the clinical management of different complications including bruising, swelling, edema, infections, lumps and bumps, skin discoloration, and biofilm formation. Special attention was paid to vascular compromise and retinal artery occlusion.ConclusionsClinicians should be fully aware of the signs and symptoms related to complications and be prepared to confidently treat them. Establishing action protocols for emergencies, with agents readily available in the office, would reduce the severity of adverse outcomes associated with injection of hyaluronic acid fillers in the cosmetic setting. This document seeks to lay down a set of recommendations and to identify key issues that may be useful for clinicians who are starting to use dermal fillers. Additionally, this document provides a better understanding about the diagnoses and management of complications if they do occur.Level of Evidence VThis 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.

Calcium hydroxyapatite (CaHA)-carboxymethylcellulose (CMC)+ has unique properties that make it optimal for lifting, contouring, and defining the jawline. This long-term follow-up of a randomized, multicenter, rater-blinded trial reports efficacy and safety of CaHA-CMC(+) through 48 and up to 60 weeks post-treatment. Eligible patients were randomized (2:1) to the treatment or the control/delayed treatment group to receive CaHA-CMC(+) injections in both jawlines. While touch-ups were permitted 4 weeks post-treatment for both groups, only the treatment group was eligible for optional retreatment after 48 weeks. The primary outcome was ≥1-point improvement on both jawlines on the Merz Jawline Assessment Scale (MJAS); secondary endpoints included the Subject Global Aesthetic Improvement Scale (SGAIS) among others. Post hoc analysis included pooling up to 48-week data from the combined treatment and control/delayed groups and 60-week data for the treatment group. Overall, 175 received treatment. MJAS responder rates were 77.9%, 78.7%, and 62.9% at 12, 24, and 48 weeks post-treatment, respectively. Responder rate on the MJAS at 60 weeks was 74.6% for those who received retreatment and 43.5% for those patients who received only the initial and touchup treatments. SGAIS scores demonstrated 93.4%, 85.6%, and 68.5% of patients rated themselves very much improved after 12, 24, and 48 weeks, respectively. Adverse events consisted of procedure or CaHA-CMC(+)-related events that were mostly resolved and overwhelmingly mild. CaHA-CMC(+) produced clinically meaningful and long-lasting improvements in jawline contour and was well tolerated in patients through 60 weeks. ClinicalTrials.gov Identifier: NCT03583359.

Hyaluronic acid fillers are used to improve the appearance of nasolabial folds (NLF). This study aimed to compare the efficacy, safety, and durability of a new hyaluronic acid gel (BioHyalux) versus Restylane for the correction of NLF. This was a multicenter, double-blinded, randomized, controlled, non-inferiority clinical trial involving 88 subjects with moderate to severe NLF. Subjects were randomized to BioHyalux and Restylane on either sides of the NLF. NLF was assessed before and right after injection, and at 1 week, 1, 3, and 6 months. Patients were followed up for 13–15 months to evaluate the durability and long-term safety. A clinically meaningful response was predefined as at least one-point improvement on the Wrinkle Severity Rating Scale, which is a five-point scale. At 6 months, the response rate of BioHyalux was not inferior to that of Restylane ( P  < 0.05). At the 13–15 months follow-up, the response rate by investigators was 58.0 % on the BioHyalux side versus 63.8 % on the Restylane side. The response rate by subjects showed similar results, which was 56.5 % on the BioHyalux side versus 60.9 % on the Restylane side at 13–15 months. The subjects’ Global Aesthetic Improvement Scale (GAIS) showed that most subjects felt improvements on both sides of NLF ( P  > 0.05) at all time points. At 6 months, 100 % reported improvements on both side; at 13–15 months, 60 % of subjects reported improvements with BioHyalux versus 64 % with Restylane. Adverse events were transient and predominantly mild or moderate in severity including injection site swelling, pain, itching, bruising, and tenderness. BioHyalux had reliable safety and tolerance, and could be an effective injectable filler for correcting NLF.

Background Various therapeutic options have been introduced for enlarged facial pores including low cross‐linked hyaluronic acid (HA) fillers. Newer formulations of HA‐based dermal fillers are continuously introduced into the market, but their effectiveness in reducing enlarged facial pores has not yet been determined. Objectives To compare the efficacy of HA‐based dermal fillers (Cohesive Polydensified Matrix HA filler; CPM‐HA20) versus CPM‐HA20 with glycerol (CPM‐HA20G) in terms of minimizing enlarged facial pores and skin quality improvement. Methods Thirty subjects with enlarged facial pores were enrolled in this randomized, double‐blinded, split‐face study. Participants were randomly assigned to be injected with 1 mL of CPM‐HA20 filler on one side of their medial cheek and 1 mL of CPM‐HA20G on the contralateral side for 3 sessions spaced 4 weeks apart. Pore volume was objectively measured by an Antera 3D. Skin biophysical properties were evaluated. Participant satisfaction and adverse events were recorded. Results Twenty‐nine participants completed the study. Both treatment groups showed a reduction in the mean pore volume from the baseline through Week 32. The CPM‐HA20G treated side showed a 24.2% higher reduction in mean pore volume from baseline compared to the CPM‐HA20 treated side (p = 0.038). Both treatment groups showed improvement in skin hydration from baseline to Week 32. There was no significant difference in patient satisfaction between the CPM‐HA20G and CPM‐HA20 treated sides. Only mild adverse events such as pain, edema, and bruising were reported. Conclusion Three‐monthly injections of CPM‐HA20G and CPM‐HA20 were effective in minimizing enlarged face pores and improving skin hydration. CPM‐HA20G demonstrated superior efficacy in terms of pore size reduction. Adverse events were generally mild and tolerable.

Background Calcium hydroxylapatite‐carboxymethylcellulose (CaHA‐CMC) injectables have emerged as dual‐purpose fillers with bioregenerative and direct filling capabilities. Aims This study investigates the rheological properties of CaHA‐CMC and its CMC carrier gel at various dilutions. Methods The storage modulus (G′), loss modulus (G″), complex viscosity (η*), loss factor (tan δ), cohesivity, and extrusion force were evaluated for a range of CaHA‐CMC aqueous dilutions with an oscillatory rheometer, drop weight testing, and force analysis, respectively. Results Results revealed a significant decrease in G′, η*, and increase in tan(δ) with increasing dilution, indicating a decline in the product's direct filling capabilities. Cohesivity decreased dramatically with dilution, potentially enhancing tissue biointegration and the product's biostimulatory effects. The CMC gel carrier displayed inelastic and non‐resilient properties, with rheological changes differing from CaHA‐CMC. Dilutional rheology was also correlated with previously published dilution‐dependent biostimulatory data where hyperdiluted CaHA‐CMC (>1:2) demonstrated a regenerative profile and diluted or hypodiluted mixtures retained meaningful filling properties and increased regeneration. Conclusions These findings offer a continuum for tailoring the product's rheological profile to match specific tissue requirements. Customizable rheology allows CaHA‐CMC to be tuned for either filling and contouring or optimal regenerative effects. Importantly, safety implications related to vascular occlusion suggest that dilutional rheomodulation decreases the risk of vascular events. In conclusion, this study highlights the significant impact of aqueous dilution on the rheological properties of CaHA‐CMC and its carrier gel. The findings support the clinical application of tailored dilutions to achieve desired outcomes, providing versatility and safety for aesthetic applications.

Background Hyaluronic acid (HA) fillers are widely used in aesthetic medicine, but their in vivo behavior and long‐term effects are not fully understood. Aims To review the decomposition and changes occurring in the body following HA filler injections, focusing on crosslinking agents, degradation processes, and tissue responses. Methods This review analyzed oxidative and enzymatic degradation processes of HA fillers, evaluated the impact of 1,4‐Butanediol Diglycidyl Ether (BDDE) crosslinking, and examined histological changes post‐injection. Results Uncrosslinked HA degrades rapidly due to endogenous hyaluronidase, while crosslinked HA undergoes slower degradation via free radicals and hyaluronidase. Complete cross‐linking (C‐MoD) showed better durability compared to partially cross‐linked BDDE (P‐MoD). The concept of modification efficiency (MoE) was proposed to optimize filler safety and viscoelastic properties. Histological analysis revealed collagen capsule formation and autologous tissue replacement, affecting long‐term outcomes. The degree of chemical modification (MoD) influences filler durability and safety, with concerns raised about potential delayed immune reactions from accumulated pendent BDDE. Conclusions Clinicians should consider injection site, tissue conditions, and filler properties for safe and effective HA filler use. Emphasizing thorough BDDE removal and optimal crosslinking can enhance treatment safety and efficacy. The balance between achieving desired viscoelastic properties and minimizing potential risks is crucial. Future studies should include diverse ethnic groups to validate findings and further explore long‐term tissue responses to HA fillers.

In regard to both natural aging and photoaging caused by UV radiation, a decrease in skin collagen and elastin fibers results in the loss of soft tissue volume. Biodegradable polymer fillers have been used to overcome this problem, but the slow rate of reconstruction and particle agglomeration has limited this approach. The DMSB01 filler, which consists of poly d-l-lactic acid (PDLLA) with a methoxy polyethylene glycol (mPEG) initiator, was created to address this issue. In this study, we assessed the reconstruction and dispersion of the DMSB01 filler in vitro, as well as its effect on collagen expression in rats. DMSB01 showed rapid reconstruction and excellent dispersion stability; gelation occurred within 5 min at 37 °C and remained stable. In an animal model, DMSB01 induced M2 macrophages, Transforming growth factor beta (TGF-β) expression, and significantly increased collagens I and III. Collagen recovery and wrinkle improvement were confirmed by the aging and photoaging models, and hematoxylin and eosin (H&E) staining was used to demonstrate the safety and biodegradability of DMSB01. DMSB01 was effective in terms of inducing collagen production and improving skin aging, and shows promise as an innovative ingredient to overcome the limitations of existing fillers.