Assessment of the Efficacy and Durability of IncobotulinumtoxinA in the Treatment of the Upper Face in Adult Women.

INTRODUCTION: IncobotulinumtoxinA (Xeomin®) is used in the treatment of dynamic wrinkles and the aesthetic repositioning of facial structures. The duration of its muscular effect typically extends for around 4 months. However, the residual aesthetic benefit can be observed for a longer period. To date, the long-term aesthetic benefit of incobotulinumtoxinA in facial aesthetics has not been systematically evaluated. This study aimed to evaluate longitudinally the duration and aesthetic benefits of incobotulinumtoxinA in the treatment of the upper face in adult women. METHODS: A quasi-experimental, evaluator-blind, clinical trial involving 28 adult women (30-60 years old) with facial movement lines, undergoing treatment of the upper face with incobotulinumtoxinA by two injectors, following an individualized protocol (ONE21 and glabellar contraction patterns) was performed. Participants were evaluated on the day of the intervention (day 0) and days 30, 120, 180, and 240, and subjected to standardized photographs. The following outcomes were evaluated blindly at each visit: Merz Aesthetics Facial Contraction Scale (MAS), GAIS (Global Aesthetic Improvement Scale), and patient satisfaction. Adverse effects were evaluated at each visit. RESULTS: Participants ranged in age from 30 to 60 years, 93% were self-declared white, and most of their baseline MAS scores for dynamic lines were moderate and severe. All the parameters presented significative reduction from baseline until day 180. At day 240, the dynamic MAS scores were lower than baseline for forehead lines in 15.4% (95% confidence interval (CI) 0.8-30.0%) of the participants, for glabellar lines in 38.5% (95% CI 18.8-58.1%), and for crow's feet lines in 26.9% (95% CI 9.0-44.8%). Aesthetic improvement compared to baseline was identified in 35% (CI 95% 23‒50%) of the participants at day 240, and 62% (CI 95% 42‒81%) of the sample kept reporting some satisfaction with the procedure. CONCLUSION: The aesthetic treatment of the upper face with incobotulinumtoxinA demonstrates enduring clinical benefits, and patient satisfaction lasting up to 180 days in most participants. The length of efficacy, which exceeded those reported in the literature, may be attributed to the use of techniques based on individualized assessment such as ONE21 and glabellar patterns of contraction.

A Combined Approach Using IncobotulinumtoxinA and CPM-Hyaluronic Acid Injections for the Periorbital Complex Improvement: A Pilot Study.

Background: Previous reports have objectively demonstrated the efficacy of botulinum toxin for brow elevation. No previous clinical trial has reported a combined approach to botulinum toxin A injection with hyaluronic acid (HA) injection in the upper face for periorbital region beautification focusing on eyebrow reshaping. Objectives: To evaluate the effect of IncobotulinumtoxinA injection using the ONE21 technique combined with HA injection (CPM technology) to redefine brow shape and position. Methods: A prospective pilot study was designed to evaluate the effect of IncobotulinumtoxinA injection using the ONE21 technique-with a preestablished scheme of doses and injection-site distribution-combined with HA injection (CPM technology) periosteally into the palpebromalar groove and subdermally in the anterior temporal region, to redefine brow shape and position. Objective eyebrow measurements were taken by an independent investigator using the Merz Aesthetic Scale (MAS) for brow positioning. Patient satisfaction was also evaluated. Some patients were also assessed using the Vectra System (Canfield Scientific, Parsippany, NJ). Results: Eleven females, aged 29 to 55 years, were included in this prospective pilot study. The totality of patients (11/100%) had at least ≥1-point improvement in the MAS brow positioning. All patients (100%) reported significant aesthetic improvement of their periorbital region and appearance, with 82% of the patients much improved. Mild side effects, such as ecchymosis and transient temporal edema, were reported. Conclusions: The combined technique improved the appearance of the orbital area by uplifting the lateral eyebrow and creating an almond-shaped eye effect, which characterizes the trending marketing term Foxy eyes. Further studies, including more cases, are needed to obtain a statistically significant outcome.

The gold protocol: A combined treatment approach for neck rejuvenation with calcium hydroxyapatite, botulinum toxin, and hyaluronic acid in the same session.

BACKGROUND: The signs of aging seem to be more visible on the neck compared to other locations, especially if a patient has already gone through facial rejuvenation procedures. Treatment of the aging neck imposes a challenge to the clinician, since one single approach is usually not enough to achieve the desired result, requiring multiple injections and sessions, which apart from being painful for the patients, is time-consuming for the clinician. AIM: To describe the use of calcium hydroxyapatite, incobotulinum toxin type A and Cohesive poly-densified matrix hyaluronic acid diluted in the same syringe and injected in the same session for neck rejuvenation. PATIENTS AND METHODS: Fifteen women, older than 18 years, with cervical skin flaccidity grade 1-4 in a previously validated 5-point rating scale (Dermatologic Surg, 2016; 42, S94), who sought neck rejuvenation were injected in this pilot study with a single session with a combined hybrid mixture of calcium hydroxyapatite, incobotulinum toxin type A, and Cohesive poly-densified matrix hyaluronic acid and followed up for 90-180 days. RESULTS: At the 4-month post injection evaluation, 93.3% of the patients presented at least 1-grade improvement in the 5-point scale as evaluated by the investigator. No serious adverse events were reported, being most mild and transient in nature. CONCLUSION: CaHA, incoBonTA, and CPM-HA have complementary mechanisms of action and may be injected from the same syringe in the same session, boosting the final outcome, with high patient satisfaction, and ease of process for both patients and clinicians.

The Anatomical Layering Assessment: The Construction of Beauty.

Restructuring an aging face from bone structure to the surface of the skin can be metaphorically compared to building and renovating a house. While each anatomical layer of the face undergoes an aging process of its own, there is also an interdependency of superficial structures on deeper layers, so that a change in one layer may lead to changes to the adjacent layers. This interaction among the structures deep into the skin, along with the skin's ability to envelope them is what determine the aspect of the aging face. Thus, a careful assessment of all the layers is imperative and we describe herein a step-by-step facial layering assessment and facial restructuring approach from bone structure to the surface of the skin to implement a treatment plan able to deliver a harmonious rejuvenating outcome.

ONE21 technique for an individualized assessment and treatment of upper face wrinkles in five pairs of identical twins with IncobotulinumtoxinA.

BACKGROUND: Facial aging is a complex process, which, beyond a genetic predisposition, involves both physical and environmental factors. Even identical twins with the same genetic load may differ substantially in facial wrinkles and aging, demanding a personalized treatment approach. OBJECTIVE: To demonstrate the ONE21 technique as an excellent tool to a customized assessment and IncobotulinuntoxinA treatment to address phenotype discordances and epigenetic drifts in identical twins, expressed by different patterns of upper face muscle contractions and wrinkles intensity. PATIENTS/METHODS: Five pairs of identical Caucasian twin sisters, from 30 to 45 years of age, were evaluated for hyperfunctional upper facial wrinkles (forehead, glabella, and periorbital), assessing the individual anatomy, muscle function and habitual facial movements of each patient. All the subjects were treated with the ONE21 technique using IncobotulinumtoxinA and reevaluated 30 days after the procedure. RESULTS: Though the clinical-anatomical pattern of the forehead contraction was similar between the pairs, the strength of the muscles, the number and depth of wrinkles differed. This varied presentation demanded distinct points of distribution and dosages of incobotulinumtoxinA for all the twins, according to the ONE21 approach. The results 30 days after treatment were satisfactory in all the subjects. CONCLUSION: The ONE21 technique allows an objective and careful evaluation of the wrinkles of the upper face, based on an individualized assessment, which may vary even in identical twins.

Consensus on the Use of Hyaluronic Acid Fillers from the Cohesive Polydensified Matrix Range: Best Practice in Specific Facial Indications.

BACKGROUND: As the treatment indications for the Cohesive Polydensified Matrix® hyaluronic acid (CPM-HA) portfolio continue to expand and diversify, injectors new to the range or those who are expanding the treatments they offer may be unsure of the optimal product and injection technique for specific facial areas. Each product in the CPM-HA portfolio has been intentionally designed to provide the best physical properties for a specific indication and target tissue. This document has been developed to provide a comprehensive, one-stop reference for clinicians using the portfolio. METHODS: An international panel of experts in the field of aesthetic medicine convened to develop guidelines on effective and safe injection technique when performing treatments with the CPM-HA range of soft-tissue fillers. RESULTS: Consensus members considered treatment indications in the upper, middle and lower face. Landmark deficiencies and anatomical considerations are described for each indication and consensus recommendations provided on the optimal product, injection depth and treatment technique. This is supplemented by the experts advice on avoidance of complications. Throughout, an evidence-based approach to selection of products and injection techniques is provided. The result is a fully tailored approach to a range of indications covering the full portfolio of CPM-HA products, including the newest addition for skin revitalization. CONCLUSION: The recommendations in this consensus document are provided to assist clinicians in the selection of CPM-HA products, administration techniques and depths of injection with the aim of providing seamless and natural treatment results, enhanced safety and patient satisfaction.

Botulinum Toxin Type A to Improve Facial Symmetry in Facial Palsy: A Practical Guideline and Clinical Experience.

Unilateral peripheral facial nerve palsy jeopardizes quality of life, rendering psychological consequences such as low self-esteem, social isolation, anxiety, and depression. Among therapeutical approaches, use of Botulinum toxin type A (BoNT-A) on the nonparalyzed side has shown promising results and improvement of quality of life. Nevertheless, the correct technique is paramount, since over-injection of the muscles can result in lack of function, leading to a "paralyzed" appearance, and even worse, functional incompetence, which may cause greater distress to patients. Therefore, the objective of this article is to provide a practical guideline for botulinum toxin use in facial palsy. To this aim, adequate patient assessment, BoNT-A choice, injection plan and dosage, and injection techniques are covered.

The One21 Technique: An Individualized Treatment for Glabellar Lines Based on Clinical and Anatomical Landmarks.

PURPOSE: Botulinum toxin type A is an effective treatment for glabellar dynamic wrinkles. As the muscular group involved in the contraction of the glabella varies among people, individualized treatment can achieve optimal results. This study evaluates a customized assessment for the treatment of glabellar lines with Incobotulinumtoxin-A, leading to an individualized points distribution and dosage. PATIENTS AND METHODS: A single-center, evaluator-blinded, therapeutic cohort study enrolled 130 women with moderate or severe glabellar wrinkles. They underwent Incobotulinumtoxin-A injection following the standard 5-point injection at the glabellar muscles (n = 65) or an individualized assessment and scheme treatment based on anatomical references of contraction, the One21 technique (n = 65). All the patients were photographed under maximum contraction before treatment (T0) and after 4 weeks (T28). The photos were randomly assessed by two blinded, experienced raters to consensually grade the severity according to the Merz Aesthetics Scales (MAS). The primary clinical efficacy was defined as a 2-point reduction in the MAS score, on Day 28. RESULTS: The groups were homogeneous regarding age, phototype, and baseline MAS scores. On Day 28 (T28), 64 (98.5%) patients from the One21 group and 52 (80%) from the 5-point group reduced the MAS score by at least two points (p < 0.01). When adjusted by age and phototype, both groups reduced the MAS score at T28 (p < 0.01); nevertheless, patients from the One21 group significantly performed better (p < 0.01), with a much higher rate response rate at T28, in comparison to the 5-point group. Of patients enrolled in the 5-point group, 83.1% utilized muscle groups other than the procerus and corrugator in glabellar wrinkle formation, and 17 (24.6%) presented asymmetrical contraction. Patients from the 5-point group with glabellar asymmetry and those who utilized the frontalis and orbicularis presented inferior performance (p < 0.05), reinforcing the importance of an individualized assessment and treatment plan. CONCLUSION: The One21 technique yielded better results than the standard 5-point treatment in reducing glabellar dynamic lines with Incobotulinumtoxin-A, especially for asymmetric lines of the glabella or the involvement of muscle groups other than the procerus and corrugator.

Aesthetic ONE21 Technique for Injecting IncobotulinumtoxinA into the Forehead: Initial Experience With 86 Patients.

BACKGROUND: Treatment of upper facial lines is a common aesthetic practice; however, there is limited information on systematic tailored approaches for the treatment of forehead wrinkles using botulinum toxin A. OBJECTIVE: To describe the safety and efficacy of the ONE21 technique using incobotulinumtoxinA (INCO) for the treatment of forehead wrinkles. METHODS: Single-center, retrospective study with 86 females presenting a baseline Merz Aesthetic Scale (MAS) score ≥2 for dynamic forehead lines who had been treated with INCO using the ONE21 technique. Assessment was performed by two independent blinded raters using MAS for forehead lines (dynamic and at rest), and eyebrow positioning, based on standardized pictures taken before (baseline) and 4 (±2) weeks after treatment injection. The primary outcome was the percentage of subjects with a MAS improvement ≥2 points for dynamic forehead lines at week 4 (±2). Secondary outcomes were MAS scores for resting forehead lines and for eyebrow positioning. RESULTS: The mean age was 46.2 years, and mean total dose of INCO, 20.3 U. Most (97.7%) subjects had a MAS improvement of ≥2 points for dynamic forehead lines at week 4 (±2); 100% improved ≥1 point. MAS scores for resting and dynamic lines, and eyebrow positioning were significantly improved (P<0.001). Eyebrow positioning MAS improved ≥1 point in 56.9% of subjects, and 39.5% maintained the original shape. CONCLUSION: INCO injection using the ONE21 technique is effective and safe in treating forehead wrinkles, providing a natural result, with a customized treatment and a predictable eyebrow shape. J Drugs Dermatol. 2021;20(1):31-37. doi:10.36849/JDD.5617.

One21: A Novel, Customizable Injection Protocol for Treatment of the Forehead with IncobotulinumtoxinA.

It is well known that incobotulinumtoxinA (INCO) is an effective approved treatment for dynamic wrinkles of the upper face caused by the action of mimetic muscles over time. In doing so, it is important to maintain a balance between muscle groups and a natural facial appearance. Patients differ enormously in their facial anatomy regarding structure and function, both within and between genders, ethnicities, and age. Therefore, treating all patients with the same injection pattern and the same doses can result in undesired outcomes. There is a need for a tailored approach to achieve optimal results, as well as to increase patient satisfaction. With this in mind, the novel one21 injection technique which allows for individualized treatment has been developed for the treatment of horizontal forehead lines using INCO, resulting in a positive impact on eyebrow position and shape. This technique is the next step in a customized approach, giving natural-looking results and high patient satisfaction.

A double-blind, randomized, comparative study of two type A botulinum toxins in the treatment of primary axillary hyperhidrosis.

BACKGROUND: Botulinum toxin (BTX) is an effective treatment for primary axillary hyperhidrosis. In this study we used two toxins not bioequivalent: BOTOX (Allergan, Inc.) and Dysport (Beaufour Ipsen Biotech). OBJECTIVE: The objective was to compare the efficacy, safety, and tolerability of BOTOX and Dysport in the treatment of primary axillary hyperhidrosis using a conversion factor of 1:3, respectively. METHODS: In a double-blind, randomized prospective study, 10 patients with primary axillary hyperhidrosis and sweat production exceeding 50 mg/minute received 50 U of BOTOX in one axilla and 150 U of Dysport in the other. We performed Minor's test and gravimetry at 0 days, at 15 days, and monthly for 1 year. RESULTS: No significant difference was observed in the sweating quantity at baseline. After 1 month all patients had achieved success for both axillae. The sweat rate was reduced by a mean of 97.7% for BOTOX and 99.4% for Dysport, without statistical difference. The duration of benefits was similar between both toxins, with a mean of 260 days for BOTOX and 290 days for Dysport, without statistical difference. The longest symptom-free interval was 12 months (5 patients, 55.6%). CONCLUSIONS: BOTOX and Dysport presented similar levels of safety and efficacy in the treatment of primary axillary hyperhidrosis when a conversion factor of 1:3 was used.