The efficacy and safety of neubotulinumtoxinA for the treatment of forehead horizontal lines in Asians - A clinical, prospective, interventional, split-face study.

BACKGROUND: Botulinum toxin injections are widely sought after in the field of medical aesthetics, offering consumers a variety of brand choices. Two commonly available botulinum toxin products, onabotulinumtoxinA and neubotulinumtoxinA, are featured in numerous clinics, leading many to question whether there are discernible differences in results, given their varying price ranges. OBJECTIVE: To evaluate the efficacy and safety of neubotulinumtoxinA for the treatment of forehead horizontal lines. METHODS: A 12-week prospective, single-centre, interventional split-face study was conducted, including 30 subjects. These enrolled subjects received a single treatment session, with neubotulinumtoxinA applied to the left side of the forehead and onabotulinumtoxinA to the right side. A superficial injection was performed in all individuals, where the product was injected subdermally in the frontalis muscle. Evaluation was conducted at baseline, 7 days, 14, days and 4, 8, and 12 weeks after treatment, both when the eyebrows were at maximum lift and in a resting position. Treatment efficacy was assessed by two physicians and self-assessed by the patients, using the Fitzpatrick Wrinkle Classification system. Adverse events were documented to evaluate safety. RESULTS: The study found no statistically significant difference in the efficacy of neubotulinum and onabotulinum for treating forehead wrinkles, as indicated by p-values above 0.05 for both static and dynamic conditions. No safety and adverse events were observed in both formulations. CONCLUSION: This study has demonstrated that neither formulation is inferior to each other in the treatment of forehead horizontal lines.

DaxibotulinumtoxinA-lanm (Daxxify™): A Comprehensive Overview.

Botulinum toxin A (BoNTA) is produced by Clostridium botulinum and widely used for aesthetic indications requiring neuromuscular blockade. For dynamic facial lines, BoNTA is effective and safe, but also temporary, requiring repeat injections approximately every 3-4 months for maintenance of effects. There is a desire by both patients and providers for a longer-lasting neurotoxin to prevent periods of suboptimal correction. Approved by the US Food and Drug Administration (FDA) in September 2022, daxibotulinumtoxinA for injection (DAXI or Daxxify™) is the first long-lasting BoNTA formulated with a 150-kDa BoNTA (RTT150) and proprietary stabilizing excipient peptide (RTP004) in place of human serum albumin. DAXI is approved for treatment of moderate to severe glabellar lines. The median duration of effect was 6 months and results lasted as long as 9 months in some patients. Its unique formulation and prolonged effectiveness positions DAXI as a safe, novel BoNTA for improved durability and patient satisfaction.

Horizontal Forehead Lines: A Reflection of Eyelid Ptosis or Blepharodermachalasia.

BACKGROUND: In his facial aesthetics practice, the senior author (B.G.) observed that many patients presenting with horizontal forehead lines also demonstrated upper eyelid ptosis or enough blepharodermachalasia to require compensation. This study was conducted to investigate this observation. METHODS: Photographs of patients presenting for facial rejuvenation were retrospectively reviewed for the presence of forehead lines, ptosis, brow ptosis, and blepharodermatochalasia. Patient age, gender, and race were reported. Only patients over age 50 were included. Patients who had previous eyelid or forehead surgery, congenital abnormalities, or post-traumatic deformities were excluded. Ptosis was defined as more than 1.5-mm overlap between the upper eyelid and the iris. Patients were divided into two groups based on presence of forehead lines for comparative analysis. RESULTS: One hundred sixty patients, including 100 patients with and 60 patients without horizontal forehead lines, were included. Patients with forehead lines were likely to be older (age 61.56 ± 8.93 vs. 58.58 ± 7.59; P = 0.0337), male (36 vs. 11.67%; P = 0.0008), have ptosis (90 vs. 76.67%; P = 0.0377), and have blepharodermatochalasis (20 vs. 5%; P = 0.0097). All 28 patients with unilateral forehead lines (17 left, 11 right) had ipsilateral ptosis. CONCLUSIONS: Ptosis and blepharodermatochalasis may result in the development of horizontal forehead lines through compensatory frontalis activation. Whenever horizontal forehead rhytids are noted, it is imperative to search for ptosis or blepharodermachalasia in repose. Otherwise, forehead rejuvenation may fail to eliminate these compensatory forehead lines, and chemodenervation may have significant adverse effects on the visual field by forcibly blocking frontalis compensation. LEVEL OF EVIDENCE III: 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 .

Evaluating the Effect of Incobotulinumtoxin A for Glabellar, Forehead, and Crow's Feet Lines Using A High Dilution.

BACKGROUND: As aesthetic preferences have evolved and patients wish their muscles to be relaxed, but not frozen, a higher dilution of incobotulinumtoxinA (INCO) has allowed for increased spread using fewer units, yet no studies to date have investigated the efficacy, longevity, and safety of hyperdiluted INCO. OBJECTIVE: We evaluated the effect of incobotulinumtoxinA (INCO) in glabellar, forehead, and lateral periorbital lines using a high dilution. METHODS: Subjects with moderate-to-severe upper facial lines at rest according to the Merz Aesthetics Scales™ (Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany) received 15U of INCO to the glabellar (n=4 injection sites), 10U to the rest of the forehead (n=10 injection sites), and 5U to the lateral periorbital lines (n=3 injection sites/eye). Primary outcomes were physician- and subject-rated improvement at one month using the Global Aesthetic Improvement Scale (GAIS) and changes in line severity using the Merz Aesthetics Scales™. RESULTS: The study included 15 women aged 35 to 65 years. At one month, physician GAIS scores indicated 91.2% of subjects were very much improved and 8.8% were much improved; 91.5%, 78.0%, and 57.6% of participants remained at least improved at four, five, and six months, respectively. Subject GAIS scores at one month were in agreement with physician scores. At one month, an improvement of at least one point in Merz Aesthetics Scales™ scores in glabellar, forehead, and lateral periorbital lines was reported in 88.9%, 98.3%, and 94.8% of participants, respectively. Subject satisfaction was high throughout the study. No treatment-related adverse events were observed. CONCLUSION: Hyperdilute INCO was effective at improving overall appearance and reducing line severity in individuals with moderate-to-severe upper facial lines. Patient satisfaction was maintained up to six months and treatment was well tolerated.

To click or not to click - The importance of understanding the layers of the forehead when injecting neuromodulators - A clinical, prospective, interventional, split-face study.

BACKGROUND: Differences in the effectiveness of neuromodulator treatments for horizontal forehead lines dependent on depth of product administration have been described. However, knowledge in respect to the fascial anatomy of the forehead still remains elusive. AIMS: To relate the fascial anatomy of the forehead to the effectiveness of neuromodulator treatments by conducting a clinical, prospective, interventional split-face study in which injections for the treatment of horizontal forehead lines are performed differently between facial sides. METHODS: This study included a total of n = 14 patients with a mean age of 35.71 (7.8) years and mean body mass index of 21.9 (3.0) kg/m2 . One side of the forehead was injected superficially by positioning the product in the superficial fatty layer, whereas the contralateral side was injected deep targeting the supraperiosteal plane (random selection). The treatment outcome was rated by the physician and by two independent observers according to a forehead line severity scale (0-4) at 14 and at 30 days. RESULTS: All three observers agreed in their ratings (ICC: 0.942) that the deep injection technique resulted in a superior outcome: D14 (superficial vs deep) 0.17 (0.4) vs 0.14 (0.4; P = .583) at rest and 1.26 (0.6) vs 0.43 (0.5; P < .001) for frontalis contraction; D30 0.17 (0.4) vs 0.14 (0.3) at rest (P = .583) and 1.21 (0.6) vs 0.43 (0.5; P < .001) for frontalis contraction. CONCLUSION: The results of this study underscore how detailed anatomic knowledge can enhance results of aesthetic interventions, in this case horizontal forehead line treatment with neuromodulators.

Tailored botulinum toxin type A injections in aesthetic medicine: consensus panel recommendations for treating the forehead based on individual facial anatomy and muscle tone.

BACKGROUND: Facial lines and wrinkles are strongly influenced by individual differences in anatomy and muscle activity and no single injection protocol will suit all patients. However, there is only limited information in the published literature on how to develop a tailored approach to botulinum toxin treatment. METHODS: An expert panel of physicians was convened to establish a consensus on developing an individualized approach to treatment of the forehead with incobotulinumtoxinA. Separate treatment protocols were developed for men and women and subdivided by background level of muscle activity: kinetic, hyperkinetic, and hypertonic. Each muscle tone category was then further subdivided to take account of individual characteristics that can influence treatment. RESULTS: Consensus members describe how to perform a dynamic assessment to optimize the dose and injection technique for each patient. A tailored treatment protocol is described for men and women with a wide range of forehead presentations. For each presentation, units of toxin as well as the precise location of injection points were defined by creating a 12-zone map of the forehead. CONCLUSION: These recommendations depart from traditional consensus documents by providing detailed incobotulinumtoxinA injection protocols for the forehead based on the major parameters that differ between patients, including muscular anatomy, size, and tone. It is expected that the use of this document will lead to more satisfactory, natural, and individualized aesthetic outcomes for patients.

Aesthetic use of BoNT: Options and outcomes.

There are a multitude of uses for BoNT in the aesthetic realm. Efficacy has been shown in softening glabellar creases, crows feet, forehead rhytides, and in correcting facial asymmetries, including mild eyelid ptosis. Facial shape can be altered through injections of BoNT into masseter, and smiles can be altered with BoNT. Clinical examples of the above will be shown, as well as adverse outcomes with inaccurate injection techniques.