Treatment Of Upper Facial Lines Research Articles

Safety and tolerability of onabotulinumtoxinA in the treatment of upper facial lines from global registration studies in 5298 participants: A meta-analysis

Since its discovery as a facial aesthetic treatment >30years ago, onabotulinumtoxinA has received worldwide approval for dynamic upper facial line treatment. Meta-analysis examining the safety of onabotulinumtoxinA for treatment of glabellar lines (GL), crow's feet lines (CFL), and forehead lines (FHL). Participants (N= 5298) with moderate to severe GL, CFL, or FHL at maximum contraction received onabotulinumtoxinA or placebo in 1 of 18 registration studies (14 double-blind, placebo-controlled [DBPC]; 1 double-blind; 3 open-label). Adverse events (AEs) were analyzed by descriptive statistics and fixed-effects meta-analysis. In the overall double-blind placebo-controlled (DBPC) population, AEs were reported in 1443 (42.1%) and 486 (35.8%) participants in the onabotulinumtoxinA (n=3431) and placebo (n=1359) groups, respectively. Serious AEs were reported in 54 (1.6%) and 17 (1.3%) participants; 1 (spontaneous abortion) was considered possibly treatment related by the investigator. Using fixed-effects statistical meta-analysis, AEs of interest that were found to be statistically higher for onabotulinumtoxinA than placebo in the DBPC population were eyelid ptosis, eyelid sensory disorder, skin tightness, brow ptosis, eyelid edema, and facial pain (P≤.05). Retrospective, ad hoc analysis. This meta-analysis confirms the onabotulinumtoxinA safety profile for GL, CFL, and FHL treatment, with no new onabotulinumtoxinA-associated AEs.

Safety considerations for treating the parotid and submandibular glands with neuromodulators for facial slimming.

Neuromodulators have predominantly been used for the treatment of upper facial lines, but their use has expanded to include lower face and neck treatments. However, the injection sites for these treatments are based on skin surface landmarks, which may pose risks to nearby structures and result in undesired outcomes. To investigate the spatial relationship between the FDA-approved skin surface landmarks for neuromodulator injections in the parotid and submandibular glands and the topographical anatomy of critical facial structures such as the facial artery, facial vein, external carotid artery, and retromandibular vein. A cross-sectional retrospective analysis was conducted on contrast-enhanced cranial CT scans. The scans were analyzed for the morphology and location of the parotid and submandibular glands. Measurements were taken for gland volume, craniocaudal extent, anterior-posterior extent, and distances between the skin surface and gland capsule or nearby structures such as arteries. The study sample consisted of 53 subjects, including 7 males and 46 females, with a mean age of 36.91 years and a mean BMI of 23.28 kg/m2 . The mean volume of the parotid gland was 31.9 ± 3.0 cc in males and 28.5 ± 3.6 cc in females with p < 0.001, while the mean volume of the submandibular gland was 18.2 ± 2.0 cc in males and 14.5 ± 3.4 cc in females with p < 0.001. The mean distances between skin surface and the gland capsule were 5.98 ± 2.2 and 8.84 ± 4.0 mm for the parotid and submandibular gland, respectively. This distance increased with higher age and higher BMI values in a statistically significant manner with p < 0.001. The distances between FDA-approved skin surface landmarks and the parotid and submandibular glands varied significantly depending on gender, age, and BMI. Optimal injection depth and location for neuromodulator treatments cannot be generalized based on these landmarks alone, emphasizing the need for real-time ultrasound imaging guidance.

SAMCEP Society consensus on the treatment of upper facial lines with botulinum neurotoxin type A: A tailored approach.

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. 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. 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. 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.

Treatment of crow's feet lines and forehead lines with Botox (onabotulinumtoxinA): Development, insights, and impact.

Extrinsic and age-related intrinsic factors contribute to the development of facial lines, including lateral canthal lines (called crow's feet lines [CFL]) and horizontal forehead lines (FHL). OnabotulinumtoxinA is a highly effective treatment for facial lines that inhibits acetylcholine release at the neuromuscular junction. This temporary chemical denervation leads to localized muscle relaxation and subsequent wrinkle reduction. Early studies of onabotulinumtoxinA treatment for facial neuronal disorders such as dystonia documented improvements in FHL and CFL. After the neurotoxin was approved for treating frown lines (glabellar lines [GL]), individuals requested treatment for other rhytids, and physicians continued assessing use in new areas. Once onabotulinumtoxinA was in clinical trial development, its efficacy and safety for CFL and FHL were successively evaluated as required by the US Food and Drug Administration and by key global health authorities, including those in the European Union, Japan, and China. Allergan, collaborating with leading physicians, established clinical programs that included novel safety and efficacy measures to meet regulatory requirements. Global, phase 3, randomized, controlled studies of CFL and FHL met rigorous primary endpoints. Some countries mandated clinical trial data beyond US and European regulations, and Allergan conducted 11 studies in total, fulfilling diverse regulatory and study population data requirements. Adverse events associated with local spread, including brow and eyelid ptosis, diplopia, headache, and eyelid sensory disorder, were infrequent and well tolerated. Consequently, onabotulinumtoxinA treatment of upper facial lines is now established globally as a highly effective, minimally invasive treatment for patients to achieve a natural appearance and look younger.

Safety, tolerability and efficacy of incobotulinumtoxinA for the long-term treatment of upper facial lines

Aesthetics procedures have increased in popularity over the last few years and have grown to be increasingly affordable to the general population. This literature review aims to explore the efficacy, tolerability, and safety of IncobotulintoxinA in the long-term treating facial lines in response to concerns regarding the effects of repeated treatments with the most currently used formulations in the market. Using the PubMed and CINAHL databases, a review of two prospective studies has been conducted. Results show that IncobotulintoxinA has less concentration of proteins in its formula, leading to less risk of developing neutralizing antibodies down the line with repeated injections. Methodological limitations of the two studies are also discussed.

Treatment of Upper Facial Lines With OnabotulinumtoxinA Results in Long-Lasting Efficacy and Patient Satisfaction

Treatment of Upper Facial Lines With OnabotulinumtoxinA Results in Long-Lasting Efficacy and Patient Satisfaction

Pooled Subject-Reported Outcomes From 2 Phase 3 Studies of OnabotulinumtoxinA for Simultaneous Treatment of Forehead and Glabellar Lines

Understanding the subjects' perspective is critical for successfully treating upper facial lines. To understand subjects' self-perception and overall satisfaction after onabotulinumtoxinA treatment for forehead and glabellar lines. This analysis pooled data from two 12-month, pivotal phase 3 studies in which toxin-naive subjects received onabotulinumtoxinA 40 U or placebo for treatment of upper facial lines. OnabotulinumtoxinA was administered as 0.1-mL injections at 10 prespecified sites (frontalis: 20 U; glabellar complex: 20 U). Each study used 3 reliable and validated patient-reported outcome instruments to evaluate subject satisfaction and appearance-related psychological effects: the Facial Line Satisfaction Questionnaire (FLSQ), the Facial Line Outcomes (FLO-11) Questionnaire, and the Self-Perception of Age (SPA) Questionnaire. In total, data for 865 subjects (608, onabotulinumtoxinA 40 U; 257, placebo) were analyzed. Treatment with onabotulinumtoxinA 40 U resulted in significant and sustained improvements across all pooled FLO-11 items and FLSQ items compared with placebo. SPA results demonstrated that a significant proportion of subjects in the pooled analysis felt they looked younger after treatment than at baseline (all, p < .0001 vs placebo). This study demonstrates a high level of treatment satisfaction and significantly improved appearance-related psychological outcomes among toxin-naive subjects after onabotulinumtoxinA 40 U treatment.

Safety, Tolerability, and Efficacy of Repeat-Dose Injections of IncobotulinumtoxinA in the Treatment of Upper Facial Lines: Results from a Prospective, Open-Label, Phase III Study

In aesthetic practice, wrinkles in the upper face are commonly treated with repeat-dose injections. The objective of this study was to investigate the safety, tolerability, and efficacy of repeat-dose injections of incobotulinumtoxinA in the combined treatment of moder-ate to severe upper facial lines (UFL) [glabellar frown lines (GFL), horizontal forehead lines (HFL), and lateral periorbital lines (LPL)]. Healthy subjects (&ge;18 years) with moderate to severe GFL, HFL, and LPL on the Merz Aesthetics Scales (MAS) at maximum contrac-tion were administered 54 to 64 U of incobotulinumtoxinA (GFL, 20 U; HFL, 10 to 20 U; LPL, 24 U) in up to four, 120-day treatment cycles. Adverse events (AE) were recorded for each cycle until 120 &plusmn; 7 days after treatment. Investigator-assessed MAS scores were evaluated for each treated area at maximum contraction on day 30 [responder = score of &ldquo;none&rdquo; (0) or &ldquo;mild&rdquo; (1)]. Subject-assessed scores for overall appearance of the upper face of &ldquo;much improved&rdquo; or &ldquo;very much improved&rdquo; were noted at day 30 of each treatment cycle on the Global Impression of Change Scale (GICS). Overall, 140 subjects were treated, and 125 subjects completed the study. Mean injected units per injection cycle ranged from 56.3 U to 57.7 U. During the four-cycle study period 17.1% of total treated subjects experienced a treatment emergent adverse event (TEAE). TEAEs of special interest were documented for 9 subjects (6.4%), in 6 of these subjects (4.3%) the TEAEs were related to treatment. No clinically significant mean changes in laboratory and vital-sign values were observed from screening to final-treatment visit. Over the study interval, a response rate of &gt; 80% on the investigator-assessed MAS was reported for all treated areas except HFL. Greater than 80% of subjects in cycles 1, 3, and 4 and 78.5% of subjects in cycle 2 reported ratings of &ldquo;much improved&rdquo; or &ldquo;very much improved&rdquo; on the GICS for the overall appearance of the upper face. Incobotu-linumtoxinA for the repeat-dose treatment of UFL is safe and well tolerated with a stable safety profile, without new formation of neutralizing antibodies and has excellent efficacy during prolonged administration. J Drugs Dermatol. 2020;19(5):461-469. doi:10.36849/JDD.2020.5013.

Safety, Tolerability, and Efficacy of Repeat-Dose Injections of IncobotulinumtoxinA in the Treatment of Upper Facial Lines: Results from a Prospective, Open-Label, Phase III Study

Safety, Tolerability, and Efficacy of Repeat-Dose Injections of IncobotulinumtoxinA in the Treatment of Upper Facial Lines: Results from a Prospective, Open-Label, Phase III Study

Efficacy and Safety of DaxibotulinumtoxinA (DAXI) for Injection for Treatment of Upper Facial Lines

Efficacy and Safety of DaxibotulinumtoxinA (DAXI) for Injection for Treatment of Upper Facial Lines

Commentary on Phase 3 Study of OnabotulinumtoxinA Distributed Between Frontalis, Glabellar Complex, and Lateral Canthal Areas for Treatment of Upper Facial Lines

Commentary on Phase 3 Study of OnabotulinumtoxinA Distributed Between Frontalis, Glabellar Complex, and Lateral Canthal Areas for Treatment of Upper Facial Lines

Safety and efficacy of incobotulinumtoxinA for the treatment of upper facial lines: A randomized, double-blind, placebo-controlled, phase 3 study with open-label extension

Safety and efficacy of incobotulinumtoxinA for the treatment of upper facial lines: A randomized, double-blind, placebo-controlled, phase 3 study with open-label extension

Efficacy and safety of incobotulinumtoxinA in the treatment of upper facial lines: Results from a randomized, double-blind, placebo-controlled, phase 3 study

Efficacy and safety of incobotulinumtoxinA in the treatment of upper facial lines: Results from a randomized, double-blind, placebo-controlled, phase 3 study

Safety, tolerability, and efficacy of repeat-dose injections of incobotulinumtoxinA In the treatment of upper facial lines: Results from a prospective, open-label, phase 3 study

Safety, tolerability, and efficacy of repeat-dose injections of incobotulinumtoxinA In the treatment of upper facial lines: Results from a prospective, open-label, phase 3 study

IncobotulinumtoxinA Is an Effective and Well-Tolerated Treatment for Upper Facial Lines: Results From an Open-Label Extension Period of a Phase III Study.

In clinical practice, different upper facial areas are commonly treated together. To evaluate the efficacy and safety of repeated incobotulinumtoxinA injections for the treatment of upper facial lines (UFL) in a 3-month open-label extension (OLEX) period. In the main study period (randomized, double blind, placebo controlled; n = 156), subjects with moderate-to-severe UFL (glabellar frown lines [GFL], horizontal forehead lines [HFL], and lateral periorbital lines [LPL]) on the 5-point Merz Aesthetics Scales (MAS) received 54 to 64 U incobotulinumtoxinA or placebo. In the OLEX, all subjects (n = 139) received 1 treatment with 54 to 64 U incobotulinumtoxinA. Investigator- and subject-assessed MAS scores were evaluated at rest and maximum contraction. Response was defined either as a MAS score of "none" or "mild" or a ≥1-point improvement in MAS scores. A clear, rapid treatment response was seen in each individual treated area and for all areas combined. At Day 30, a response of none or mild at maximum contraction (investigator's rating) was reported for 80.1%, 77.2%, and 66.9% of subjects for GFL, HFL, and LPL, respectively. IncobotulinumtoxinA was well tolerated, with no evidence of an increase in adverse events with repeat injection. IncobotulinumtoxinA is highly effective for the simultaneous treatment of UFL with a good safety profile (EudraCT Number: 2011-005887-20).

Efficacy and safety of incobotulinumtoxinA in the combined treatment of upper facial lines: Results of the first prospective randomised, double-blind, placebo-controlled, multicentre phase III study

Efficacy and safety of incobotulinumtoxinA in the combined treatment of upper facial lines: Results of the first prospective randomised, double-blind, placebo-controlled, multicentre phase III study

Botulinum toxin type A treatment to the upper face: retrospective analysis of daily practice

BackgroundBotulinum toxin type A treatment has been used for over 20 years to enhance the appearance of the face. There are several commercially available botulinum toxin type A products used in aesthetic clinical practice. The aim of this retrospective analysis was to compare the clinical efficacy of the most commonly used botulinum toxin type A preparations in daily practice.MethodsPhysicians from 21 centers in Germany completed questionnaires based on an inspection of subject files for subjects 18 years of age or over who had received at least two, but not more than three, consecutive treatments with incobotulinumtoxinA, onabotulinumtoxinA, or abobotulinumtoxinA within a 12-month period in the previous 2 years. Data on subject and physician satisfaction, treatment intervals, dosages, and safety were collected from 1256 subjects.ResultsThere were no statistically significant differences between incobotulinumtoxinA and onabotulinumtoxinA with respect to physician and subject satisfaction, dosages, and adverse effects experienced. Both botulinum toxin type A preparations were well tolerated and effective in the treatment of upper facial lines. Due to low treatment numbers, abobotulinumtoxinA was not included in the statistical analysis.ConclusionThe results of this retrospective analysis confirm the results of prospective clinical trials by demonstrating that, in daily practice, incobotulinumtoxinA and onabotulinumtoxinA are used at a 1:1 dose ratio and display comparable efficacy and safety.

Patient satisfaction with different botulinum toxin type A formulations in the treatment of moderate to severe upper facial rhytids

Background: The clinical characteristics of botulinum toxin type A (BoNTA) depend on the formulation used. Objective: To evaluate whether switching BoNTA formulations affects patient satisfaction. Methods: Forty patients enrolled and all were satisfied or extremely satisfied with Allergan BoNTA (BoNTA–Allergan) treatment in the glabellar±crow's feet±forehead area(s) in the preceding 6 months. Once improvement from this previous treatment had started to diminish, treatment was replicated using Ipsen BoNTA (BoNTA–Ipsen) at a 1:2.5 dose ratio. Results: The incidence of patients rating treatment as effective or very effective in making them look younger, look rested, and look less stressed was significantly higher with BoNTA–Allergan than BoNTA–Ipsen – 83% versus 36%, 90% versus 39%, and 83% versus 33%, respectively – even though evaluations were performed a mean of 20 weeks after BoNTA–Allergan treatment and only 16 weeks after BoNTA–Ipsen treatment. The incidence of patients who were satisfied or extremely satisfied was 100% (BoNTA–Allergan) versus 31% (BoNTA–Ipsen). BoNTA–Allergan was preferred by 69% of patients. Conclusions: Efficacy, satisfaction, and product preference ratings strongly favor the use of BoNTA–Allergan over BoNTA–Ipsen in the treatment of upper facial lines. Many patients who are satisfied with BoNTA–Allergan treatment become less satisfied if they are switched to BoNTA–Ipsen.

Cosmetic uses of botulinum toxins for lower aspects of the face and neck

The ability of botulinum toxin A (BTX-A) to improve the appearance of facial lines was first reported among patients who had been receiving injections for facial dystonias or surgical procedures. Since that time, there has been very extensive use of this treatment for relaxation of a wide variety of facial muscles and also for platysmal lines of the neck. Considerable experience over the last decade or longer confirms the safety and efficacy of BTX-A in the treatment of upper facial lines. BTX-A has been used also lower facial indications, but published papers are mainly uncontrolled observations on patients. 1-3 Unlike the placebo-controlled studies on the upper face 4-7, there is a lack of controlled studies for lower face and neck BTX-A treatment. This article will summarize the use of BTX-A for the lower face and its role as combination treatment. Examples of combinations that may be used with BTX-A resurfacing, nonablative skin rejuvenation and skin fillers. Although little used at present, Botulinum Toxin B will be briefly discussed.