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Muscles involved in glabellar frown lines. Reproduced with permission from Merz Pharmaceuticals GmbH.
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Objectives
This review examines the pharmacologic and clinical characteristics of incobotulinumtoxinA (Xeomin®/Xeomeen®/Bocouture®/XEOMIN Cosmetic™; botulinum toxin type A [150 kDa]), which is free from complexing proteins, and discusses its efficacy and safety in the treatment of glabellar frown lines. Differences between incobotulinumtoxinA and o...
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Introduction
The application of botulinum toxin type A (BoNTA) is accelerating, and this includes the uncontrolled cosmetic use of the BoNTA. Diffusion of BoNTA can disturb neuromuscular transmission in several surrounding and distant muscles and result in clinical manifestations similar to myasthenia gravis (MG).
Case presentations
We report two...
Citations
... Botulinum toxin type A (BTX-A) injection is the most commonly used treatment for managing facial rhytids due to its effectiveness and safety profile, with minimal adverse effects typically derived from the manual injection technique [1][2][3][4][5]. They include the formation of hematomas, mild localized pain around the application area, and less frequently, the presentation of blepharoptosis due to the spread of the neurotoxin toward the levator palpebrae muscle [6]. ...
... IncoBTX-A, a BTX-A (150 kDa) marketed as Xeomin Ò /Bocouture Ò , is the only product free from complexing proteins, which considerably reduces the risk of generating neutralizing anti-toxin antibodies [1][2][3][4]. This presentation contains only the active neurotoxin, reducing the foreign protein load and minimizing the risk of immunogenicity [4]. ...
... Regarding the excipients, the two products contain human serum albumin. They differ in that onaBTX-A contains sodium chloride, and incoBTX-A contains sucrose [2,3]. OnaBTX-A contains complexing proteins such as hemagglutinin to increase the size of the injected complex and reduce its possibility of migration, while incoBTX-A lacks these neurotoxin-associated proteins and retains safety and efficacy profiles equivalent to conventional BTX-A presentations [3,4]. ...
The occurrence of a hypersensitivity reaction with the injection of botulinum toxin type A (BTX-A) in cosmetic use is a rare complication. We report the largest case series of temporary delayed hypersensitivity reaction (DHR) with BTX-A following COVID-19 vaccination and the first cases to incobotulinum toxin A (incoBTX-A).
A retrospective multicentric case series of patients who developed a DHR to BTX-A after COVID-19 vaccination.
Twelve patients were treated with BTX-A injections for the management of facial rhytids. The age range was between 29 and 45 years. Ten (83.3%) were female. Ten (83.3%) patients received incoBTX-A, and two received onabotulinum toxin A (onaBTX-A). All patients had COVID-19 vaccination (mRNA vaccine) between 1 and 7 months before. Within an average time of 24 h after BTX-A injection, all patients developed progressive facial swelling and erythema that were more prominent at the injection points. Intradermal allergic tests to BTX-A were performed in six (50%) patients, and the results were all negative. Adequate clinical control was achieved with systemic corticosteroids and antihistamines. After 1 year with no further vaccination, a new BTX-A treatment (provocation test) was performed in all patients with no secondary effects.
Previous COVID-19 vaccination and the absence of new adverse events with further BTX-A injections suggest a temporary DHR. Clinicians should be aware of the importance of immunization history and its potential post-vaccine immunogenic effects with BTX-A.
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 Authorswww.springer.com/00266 .
... Studies have been carried out on the pharmaceutical and biological properties of the different BTA presentations, finding a 1:1 relationship between Xeomeen® and Botox ® (Allergan, Irvine, CA), and these in turn 1: 2.5-3 with Dysport ® (Ipsen Ltd, Slough, Berkshire, UK) 10 . Its application in the muscles of the lateral wall of the abdomen will condition a flaccid paralysis that will allow its lengthening temporarily 11 , with a maximum effect reported between week 4 and 6 after its application, which is reversible and can last from 6 to 9 months. ...
... A favor del empleo de la TB en climas más calurosos, y su posible mayor duración, hace que algunos autores se decanten a favor de emplear preparaciones que solo contienen la TB de 150 kD, sin proteínas complejantes. No obstante, la evidencia que se tiene es insuficiente todavía como para generalizar esta recomendación [47]. ...
La toxina botulínica es el tratamiento más empleado en medicina estética; en consecuencia, las quejas de la menor duración del efecto de la toxina en los pacientes son causa de preocupación entre los médicos. Los responsables de la fabricación y distribución de las toxinas niegan que exista una causa dependiente del fabricante con relación al acortamiento de la eficacia de las toxinas. El objetivo de este trabajo es analizar las distintas causas que, según nuestra experiencia, pueden repercutir en la duración del efecto de la toxina botulínica. Para ello se ha llevado a cabo una extensa revisión de artículos publicados sobre el tema. Las posibles causas de una menor duración pueden estar ligadas, de una parte, al propio paciente y su particular respuesta inmunitaria. De otra parte, están todas las causas no relacionadas con la respuesta inmunitaria. En primer lugar, la asociación de las diferentes toxinas comercializadas con las proteínas acompañantes, capaces de condicionar el tiempo de inicio o la difusión hacia los receptores neuromusculares. En segundo lugar, la gesticulación ligada a la expresión de emociones del paciente. Por último, la reconstitución de la toxina y la técnica de inyección del médico son otros tantos factores que influirán en la duración del efecto. En conclusión, para obtener buenos resultados hay que tener en cuenta todas las posibles causas que pueden influir negativamente en la duración del efecto, estudiar bien al paciente, aplicar los tratamientos con intervalos seguros y abstenerse de emplear toxinas de dudoso origen.
... Treatment protocols for other glabellar contraction patterns may require adjustment depending on the muscles involved and their relative dominance. 35 Thus, hypertonic muscles are treated with higher doses or a greater number of injection sites, while those less used receive lower doses. 33 For tailored treatment of glabellar lines, the experts recommended a customized treatment plan, in which patients are injected according to their individual needs in terms of dosage, targeted muscles, and injection points (Figure 7). ...
Background:
The safety and efficacy of botulinum neurotoxin type A (BoNTA) treatments are well established, but injection techniques, target muscles, and toxin doses continue to evolve, with each refinement producing improvements in treatment outcomes. The recommendations in this consensus move away from standard templates and illustrate how to tailor treatments to individual patterns and strengths of muscle activity, and patient preferences.
Methods:
Seventeen experts in the fields of plastic surgery, dermatology, ophthalmology, otorhinolaryngology, and neurology convened in 2022 to develop consensus-based recommendations for the use of botulinum toxin A for the treatment of horizontal forehead lines, glabellar frown lines, and crow's feet lines that reflect current clinical practice. The focus was on how to tailor injections to individual patients to optimize treatment outcomes.
Results:
For each upper face indication, consensus members describe how to perform a dynamic assessment to optimize the dose and injection technique for each patient. A tailored treatment protocol is presented for commonly observed patterns of dynamic lines. Units of Inco are defined and the precise location of injection points, illustrated with the use of anatomical images.
Conclusion:
This consensus provides up-to-date recommendations on the tailored treatment of upper facial lines based on the latest research and collective clinical experience of the expert injectors. Optimal outcomes require thorough patient evaluation, both at rest and during animation, using both visual and tactile cues; detailed understanding of facial muscular anatomy and how opposing muscles interact; and use of a BoNTA with high precision to target identified zones of excess muscle activity.
... Studies have been carried out on the pharmaceutical and biological properties of the different BTA presentations, finding a 1:1 relationship between Xeomeen® and Botox ® (Allergan, Irvine, CA), and these in turn 1: 2.5-3 with Dysport ® (Ipsen Ltd, Slough, Berkshire, UK) 10 . Its application in the muscles of the lateral wall of the abdomen will condition a flaccid paralysis that will allow its lengthening temporarily 11 , with a maximum effect reported between week 4 and 6 after its application, which is reversible and can last from 6 to 9 months. ...
Post-incisional ventral hernia is estimated at 5-30%, when the content of the abdominal cavity migrates to the hernial sac (HSV), with a HSV/abdominal cavity volume ratio > 25%, conditioning systemic changes defined as "loss of domain". A 27-year-old male presented with ventral hernia with loss of domain that required pre-operative preparation techniques, using application of botulinum toxin A (IncobotulinumtoxinA) and pneumoperitoneum, both guided by image. A ventral plasty was performed with adequate return of the viscera to the abdominal cavity. The combination of both techniques seems to be a safe procedure to carry out a tension-free repair.
... The four BoNT/A preparations available in Russia may differ not only in terms of formulation but also in terms of their relative efficacy and tolerability profiles. [13][14][15]30,32 It is important to understand the similarities and differences between available BoNT/A products, as this enables clinicians to make informed decisions about their most appropriate applications in clinical practice. ...
Background
Although there are various international consensus recommendations on the use of botulinum neurotoxin type A (BoNT/A) in facial aesthetics, there are no global or Russian guidelines on the optimal dose of incobotulinumtoxinA, free from complexing proteins, within specific aesthetic indications. This article reports the outcomes of two expert consensus meetings, conducted to review and analyze efficacy and tolerability data for incobotulinumtoxinA in various facial aesthetic indications and to give expert consensus recommendations to ensure best clinical practice among Russian clinicians.
Methods
Thirteen dermatology and/or plastic surgery experts attended meetings held in Paris, France (November 2013), and Moscow, Russia (March 2014). The expert group reviewed and analyzed the existing evidence, consensus recommendations, and Russian experts’ extensive practical experience of incobotulinumtoxinA in aesthetics to reach consensus on optimal doses, potential dose adjustments, and injection sites of incobotulinumtoxinA for facial aesthetics.
Results
All experts developed guidance on the optimal doses for incobotulinumtoxinA treatment of different regions of the upper and lower face. The expert panel agreed that there are no differences in the efficacy and duration of the effect between the four BoNT/As that are commercially available for facial aesthetic indications in Russia and that, when administered correctly, all BoNT/As can achieve optimal results. Experts also agreed that nonresponse to BoNT/A can be caused by neutralizing antibodies.
Conclusion
On the basis of the scientific and clinical evidence available for incobotulinumtoxinA, coupled with the extensive clinical experience of the consensus group, experts recommended the optimal doses of incobotulinumtoxinA effective for treatment of wrinkles of the upper and lower face to achieve the expected aesthetic outcome. These first Russian guidelines on the optimal use of incobotulinumtoxinA for augmentation of glabellar lines, periorbital wrinkles, forehead lines, bunny lines, perioral wrinkles, depressor anguli oris, mentalis, masseters and platysmal bands, and performing the Nefertiti lift, are presented here.
... 8 Currently, in aesthetics, incobotulinumtoxinA is indicated for GFL in the USA and all major European markets, hyperkinetic facial lines in Mexico, mimic lines in Russia, and (most recently) CF in the European Union; 1 however, it is also an effective treatment for other aesthetic indications, including horizontal forehead lines (HFL), masseteric hypertrophy, and platysmal bands. 1,[9][10][11][12][13][14][15][16][17][18] OnabotulinumtoxinA is licensed to treat CF as well as GFL. 4 A head-to-head study comparing onabotulinumtoxinA with incobotulinumtoxinA found that the latter was also a long-lasting, effective, and well-tolerated treatment for CF, with no significant difference between the agents when administered at the same dose. 19 Similarly, a recent double-blind study with crossover evaluation found that incobotulinumtoxinA and onabotulinumtoxinA demonstrated similar clinical efficacy in the treatment of CF when administered at identical doses of 12 U per site. ...
Purpose
To characterize utilization patterns and treatment satisfaction with incobotulinumtoxinA for aesthetic indications and assess adherence to the Summary of Product Characteristics.
Patients and methods
Data were collected retrospectively from physicians in Germany, France, and the UK regarding patients (n=638) treated with incobotulinumtoxinA for aesthetic indications. Data on indication, treatment interval, dose injected, physician and patient satisfaction, and adverse drug reactions were recorded according to routine daily practice.
Results
Most patients (76.0%) received incobotulinumtoxinA for glabellar frown lines (GFL) and were given doses of ≤20 U. The majority of treatment intervals were 5 months or longer. Overall, 64.1% of patients were treated for off-label indications, sometimes in combination with treatment for GFL. The most frequently treated off-label indications were horizontal forehead lines (38.6%) and/or crow’s feet (CF; 31.7%); for CF, >95% of injected doses were ≤24 U. In Germany, a smaller proportion of patients were given incobotulinumtoxinA treatment for CF (27.6%), compared with France (40.4%) and the UK (33.2%), although country-specific differences were less prominent when treatment cycle data for CF were examined. Treatment satisfaction among physicians and patients (overall, and for GFL specifically) was very high, with excellent tolerability and only one mild adverse drug reaction reported.
Conclusion
In daily practice, incobotulinumtoxinA is mainly used for GFL; however, its use for CF and horizontal forehead lines (often in combination with GFL) is relatively common. Treatment satisfaction across aesthetic indications is high, and incobotulinumtoxinA is well tolerated, with time intervals of 5 months or longer between injections in the majority of cases. When considering factors such as dose and treatment interval, adherence to the Summary of Product Characteristics when treating GFL in daily practice is good. These results support previous reports that incobotulinumtoxinA is an effective treatment for GFL, with an excellent safety profile. Furthermore, incobotulinumtoxinA may display efficacy and tolerability in other indications.
... The subtraction of these inactive or denatured protein complexes theoretically results in a lower antigen load, decreasing the chance that the subject will develop neutralizing antibodies to treatment over time that could result in diminished clinical efficacy. [11,18] IncoBTX-A received FDA approval for the treatment of glabellar frown lines in 2011, and a phase III clinical trial conducted that same year confirmed its efficacy for this indication, in accordance with FDA-mandated scoring criteria. [19] One comparative trial of onaBTX-A and incoBTX-A reported overall high rates of patient satisfaction with both treatments and no statistically significant difference in satisfaction rates between the two neuromodulators. ...
Aim: Incobotulinumtoxin A (xeomin) has been proposed as an alternative to abobotulinumtoxin A (dysport) and onabotulinumtoxin A (Botox) in the treatment of glabellar frown lines. A recent study is comparing abobotulinumtoxin A and onabotulinumtoxin A revealed equivalent efficacy with a dose conversion ratio of 2.5:1. We sought to establish effectiveness and dosing equivalency of incobotulinumtoxin A vs. abobotulinumtoxin A.
Methods: Inclusion criteria for this pilot study included patients of a single surgeon (LAC) who had previously received a constant dose of abobotulinumtoxin A over at least four consecutive treatment sessions for the previous 12 months to achieve an 85-90% elimination of dynamic glabellar frown lines. The primary outcome sought dose comparison between established maintenance abobotulinumtoxin A dosing and incobotulinumtoxin A first-time dosing. A 2:1 conversion (abobotulinumtoxin A: incobotulinumtoxin A) was chosen in most patients. Secondary outcomes were patient-reported onset of effect, physician-assessed effect at 10-12 weeks, pain associated with administration, and patient perceived need for re-treatment at 2 weeks.
Results: A total of 32 subjects were included. The mean dose of incobotulinumtoxin A was 17.1 units (± 6.1, the median dose 20 units). The mean dose of abobotulinumtoxin A was 27.6 (± 11.7, the median dose 27.5 units). The mean difference in treatment units was -10.5 (95% confidence interval, P < 0.001). Among 30 patients who reported effect onset, the median was 8.5 days, with a range of 1-14. At 10-12 weeks, muscle paralysis was assessed to be 69.2% (± 27.3), vs. 90.3% (± 1.8) with abobotulinumtoxin A (P < 0.001). The majority of patients rated pain of administration as equal or greater to that of abobotulinumtoxin A (63% and 22%, respectively). Three patients (9%) required re-treatment at 2 weeks with abobotulinumtoxin A due to lack of effective treatment with incobotulinumtoxin A. Abobotulinumtoxin A re-treatment was chosen by the patient.
Conclusion: We found incobotulinumtoxin A at 17.1 (± 6.1) units to be less effective than abobotulinumtoxin A at 27.6 (± 11.7) units in the treatment of glabellar frown lines at 10-12 weeks postadministration. Dosing was less predictable than dosing associated with abobotulinumtoxin A treatment. Larger, randomized controlled trials are indicated to further delineate these differences and to clarify whether this difference from previously published incobotulinumtoxin A dosing may have been due to the small sample size.
... Desde la cuarta década de la vida, varios signos del envejecimiento inician su aparición y se hacen más evidentes con los años, entre ellos los surcos glabelares (del entrecejo) se hacen más evidentes y profundos incluso cuando el individuo está en reposo, en lugar de ser dinámicos y estar presentes sólo cuando se comunican emociones. 3 A medida que envejece la cara, las arrugas, los surcos y el tejido ptósico se vuelven más sobresalientes. La acción repetida de los músculos produce arrugas y surcos prominentes en áreas miméticas de la cara, como la glabela, la piel periorbitaria, los pliegues nasolabiales y la piel perioral. ...
Background: Correction of acne scars with subcision is a well-known and widely performed technique. Subcision can also be performed as an alternative to diminish the appearance of the glabellar furrow, it is a low cost procedure with minimal adverse events and positively improves quality of life of patients (QoL). Objective: To determine the efficacy of subcision with Nokor 18 needle for the correction of glabella furrow and evaluation of the QoL of patients. Material and method: A clinical, controlled and unicentric study (pilot) was done, previous authorization of the Research and Ethics Committees and signature of informed consent, including 10 Mexican patients from the Dermatology Department at General Hospital of Mexico, phototypes III/IV, for subcision of severe glabellar furrow with Nokor 18 needle. Results: Subcision was performed in 8 female and 2 male patients, the average age of the group was 48.5 years. Improvement of the appearance of glabellar furrow was very slight in one patient, slight in two patients, moderate in four and marked in three patients. The subjective perception of improvement was slight in 4/10 patients, moderate in 3/10 patients and marked in 3 patients. We did not have any important adverse event in this pilot study. Conclusions: Improvement of the glabellar furrow by means of subcision proved to be a safe, effective, economic and minimally invasive technique in this pilot study, but more studies are needed to evaluate this technique thoroughly.
... это может снижать риск формирования нейтрализующих антител и соответственно вероятность потери чувствительности к БТА и эффективности метода [7]. при этом эффективность нового препарата не отличается от таковой содержащих комплексообразующие белки препаратов БТА, что показано в сравнительных исследованиях на примере коррекции как эстетических проблем, так и лечения неврологических расстройств [8][9][10][11][12][13][14][15][16]. популярными становятся процедуры не только в верхней, но и в нижней части лица с комбинированным применением ботулинического токсина, филлеров и других методов. ...
A prospective- blind- split-face- comparative study with evaluation of clinical efficacy- tolerability- and safety parameters of two botulinum toxin A (BTA) products (the one containing complexing proteins — Disport®- Ipsen- France/ abobotulinumtoxinA and the one free from complexing proteins — Xeomin®- Merz Pharma- Germany/incobotulinumtoxinA) used for correction of lateral periorbital wrinkles (crow's feet) was performed (at that- electromyographic evaluation of changes in functions of the orbicular muscle of eye was performed for the first time). Materials and Methods. Single injections of both BTA products with equal dose ratio of 3:1 (27 IU Disport® and 9 IU Xeomin®) were performed simultaneously to the right and left side half of the face (orbicular muscles of eye)- respectively- to each of 20 volunteers (women at the age of 40.9) with marked and moderate lateral periorbital wrinkles (2—3 degree according to 4-point Facial Wrinkle Scale/FWS). Clinical and electromyographic assessment was performed 2 weeks- 4 and 6 months after injections. Results. The effect of single dosing of Disport® and Xeomin® did not significantly differ at all assessment time points: both for primary efficacy criterion and for all secondary efficacy criteria; as well as for clinical evaluation by the investigator-subjects’ self-evaluation- and dynamics of M-response parameters for the orbicular muscle of eye. Good tolerability and safety were registered. Conclusion. Study results provided convincing evidence that Disport® and Xeomin® used in accordance with the proposed protocol had a comparable effect and duration of the effect on lateral periotbital wrinkles and the orbicular muscle of eye.
