High Patient Satisfaction for up to 6 Months With OnabotulinumtoxinA Treatment for Upper Facial Lines.

BACKGROUND: OnabotulinumtoxinA safety and efficacy are well established for upper facial lines (UFL), including forehead lines (FHL), glabellar lines (GL), and crow's feet lines (CFL). OBJECTIVE: To investigate the association of onabotulinumtoxinA efficacy with patient-reported psychological impacts and satisfaction in UFL. MATERIALS AND METHODS: A pooled analysis of data from 4 pivotal Phase 3 trials (onabotulinumtoxinA vs placebo in FHL ± GL, FHL + GL ± CFL, CFL, and CFL + GL for ≤180 days) evaluated investigator-assessed ≥1-grade severity improvement on the Allergan Facial Wrinkle Scale at Day 30 (responders). Facial Line Outcomes (FLO-11) Questionnaire, Facial Line Satisfaction Questionnaire (FLSQ), and Subject Assessment of Satisfaction of Appearance (SASA) were used to evaluate responder appearance-related psychological impacts and satisfaction. RESULTS: OnabotulinumtoxinA patients, by primary study focus (FHL, GL, or CFL), totaled 921, 921, and 833, respectively; 786 patients received placebo. Most patients were female, White, and aged 45 to 50 years (median). Through 150 days, >42% FHL, >43% GL, and ≥32% CFL patients were onabotulinumtoxinA responders. Responders reported improvements in appearance-related psychological impacts (FLO-11) and high satisfaction (FLSQ and SASA), sustained through ≥150 days. CONCLUSION: A ≥1-grade improvement with onabotulinumtoxinA is a clinically meaningful outcome in UFL, associated with long-lasting improved patient-reported psychological impacts and high satisfaction.

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

BACKGROUND: Although commonly practiced, simultaneous onabotulinumtoxinA injections to multiple facial areas have not been investigated in prospective studies. OBJECTIVE: Evaluate safety and efficacy of onabotulinumtoxinA for treatment of forehead lines (FHL) distributed between the frontalis (20 U) and glabellar complex (20 U), with or without simultaneous lateral canthal areas (crow's feet lines [CFL], 24 U) treatment. METHODS: Subjects with moderate to severe FHL were randomized (2:2:1) to onabotulinumtoxinA 40 U, onabotulinumtoxinA 64 U, or placebo. After 180 days, subjects could receive up to 2 additional open-label onabotulinumtoxinA 64 U treatments. RESULTS: The intent-to-treat (ITT) population comprised 787 subjects, and the modified ITT (mITT) population (subjects with psychological impact) comprised 568. After 30 days, onabotulinumtoxinA 40 U and 64 U significantly improved investigator- and subject-assessed FHL severity by at least 2 Facial Wrinkle Scale (FWS) grades in 45.6% and 53.0% of ITT subjects, respectively, versus 0.6% receiving placebo (both, p < .0001). Significantly more mITT subjects receiving onabotulinumtoxinA achieved investigator- and subject-assessed FWS ratings of none/mild versus placebo (p < .0001). OnabotulinumtoxinA was well tolerated. CONCLUSION: OnabotulinumtoxinA distributed between the frontalis and glabellar complex, with or without additional CFL injections, was safe and effective for treatment of moderate to severe FHL.

A prospective, observational study of the volumizing effect of open-label aesthetic use of Juvéderm® VOLUMA® with Lidocaine in mid-face area.

INTRODUCTION: Juvéderm® VOLUMA® with Lidocaine is a hyaluronic acid (HA)-based injectable gel that is used to restore the volume of the face. This study was designed to assess the real-world effectiveness of this HA gel over 21 days when used for mid-face augmentation in normal, healthy subjects desiring aesthetic improvement. MATERIALS AND METHODS: This prospective, observational, single-arm, open-label post-marketing study enrolled 115 healthy subjects, from five European centers. The primary objective was to evaluate subject-reported satisfaction and experience of the treatment across a range of doses of Juvéderm® VOLUMA® with Lidocaine (1 ml/2 ml/combination), immediately after injection and 21 days post-treatment. RESULTS: Subject satisfaction questionnaire (SSQ) scores of Delighted or Happy were given by 95.6% of subjects immediately after injection, and by 93.7% of subjects at Day 21. Overall, subject and investigator satisfaction with cosmetic effect and smoothness was very positive. Pain was minimal; most subjects experienced only minor degrees of discomfort, and this was mainly related to the procedure itself. CONCLUSIONS: Juvéderm® VOLUMA® with Lidocaine was well accepted by both subjects and investigators, associated with high levels of satisfaction, was considered smooth and easy to use, and was well tolerated when used for the treatment of mid-face area volume enhancement.

Self-perception of natural outcome, appearance, and emotional well-being after OnabotulinumtoxinA treatment for upper facial lines: Post hoc analysis across age and gender.

BACKGROUND: OnabotulinumtoxinA (onabotA) is indicated for upper facial lines (UFL). Fear of unnatural-looking outcomes is a frequently reported treatment barrier. AIMS: Examine patient-reported outcomes (PROs) after onabotA treatment for UFL. METHODS: A post hoc analysis was conducted on two 12-month pivotal studies of onabotA for forehead and glabellar lines (20 U each), with/without treatment of crow's feet lines (±24 U). This analysis used PROs from the Facial Line Satisfaction Questionnaire: Items 4 (natural look), 5 (treatment effect), 11 (met expectations), and Impact Domain (appearance and psychological impact). The analysis included 458 neurotoxin-naive adults achieving a ≥2-grade improvement in forehead line (FHL) severity on the Facial Wrinkle Scale at Day 30 (primary endpoint). [Corrections made on 28 December 2023, after first online publication: 'UFL' in the previous sentence has been corrected to 'forehead line (FHL)' in this version.] Data were further stratified into millennials and men. RESULTS: At Day 30, 90.5% of all participants, 94.6% of millennials, and 85.7% of men were satisfied with receiving a natural look. Millennials had higher odds of being satisfied with natural outcomes at Day 30. This measure remained > 80% for all groups throughout the 12 months. Additionally, ≥80% were satisfied with the treatment effect, and >90% reported results met expectations. At Day 30, ≥50% reported positive impacts on self-perceived appearance and psychological well-being, but millennials had higher, and men had lower odds of reporting these improvements. CONCLUSIONS: Participants achieving a ≥2-grade improvement in FHL severity after onabotA reported high satisfaction with natural outcomes and the treatment effect, with improved self-perceived appearance and psychological well-being. [Corrections made on 28 December 2023, after first online publication: 'UFL' in the previous sentence has been corrected to 'FHL' in this version.] These results may help aesthetic providers and patients address fears regarding unnatural results with onabotA.

The Patient Journey in Facial Aesthetics: Findings from a European Consensus Meeting on Improving the Quality of Life for Patients Receiving Botulinum Toxin Injections.

Purpose: Successful treatment of facial lines with botulinum toxin is largely dependent on patient satisfaction; thus, a structured treatment journey that uses patient-reported outcomes (PROs) is helpful for maximizing botulinum toxin results. To develop a patient-centric approach for botulinum toxin injections in facial aesthetics, a group of clinicians met to provide opinions on an optimal treatment journey that uses PROs to quantify treatment benefits on patient quality of life. Patients and Methods: A multidisciplinary panel of 9 clinicians with expertise in facial aesthetic procedures convened for an advisory board that was preceded by and followed up with a structured, multistep consensus discussion. Based on current literature, the panel's expertise, structured questions, and group discussion, panelists assessed, reconciled, and agreed upon on a patient journey for botulinum toxin treatment in facial aesthetics. Results: Panelists agreed that an optimal patient journey includes screening, assessment, treatment, posttreatment, and follow-up visits. A compact, easy-to-complete, and digital PRO questionnaire should be provided before the visit. During screening, thorough assessments are integral for a successful patient journey because they provide an opportunity to understand treatment goals, address patient concerns, discuss risks and benefits, obtain medication lists/medical history, and take pretreatment photographs. Treatment strategies should include discussing and educating on the approach/choice of botulinum toxin and ensuring patients are comfortable. Posttreatment, clinicians should request intense muscle movements to enhance product uptake and be available to address patient concerns. Finally, during follow-up, PRO questionnaires can be provided to gauge patient satisfaction with treatment, and pretreatment photographs can be provided to allow patients to track their progression. Follow-ups should be scheduled with new patients or those reporting low satisfaction. Conclusion: Establishing a relationship, being aware of the patient's goals, and developing an individualized care plan allows for a structured, patient-centered treatment journey that promotes positive aesthetic outcomes.

A review of the metabolism of 1,4-butanediol diglycidyl ether-crosslinked hyaluronic acid dermal fillers.

BACKGROUND: Cosmetic procedures are growing ever more common, and the use of soft tissue fillers is increasing. Practicing physicians need to be aware of the biological behavior of these products in tissue to enable them to respond to any safety concerns that their patients raise. OBJECTIVES: To provide an overview of the metabolism of 1,4-butanediol diglycidyl ether (BDDE)-crosslinked hyaluronic acid (HA) dermal fillers and to examine the safety of the resulting byproducts. METHODS: A review of available evidence was conducted. RESULTS: After reaction with HA, the epoxide groups of BDDE are neutralized, and only trace amounts of unreacted BDDE remain in the product (<2 parts per million). When crosslinked HA, uncrosslinked HA, and unreacted BDDE degrade, they break down into harmless byproducts or into byproducts that are identical to substances already found in the skin. CONCLUSION: Clinical and biocompatibility data from longer than 15 years support the favorable clinical safety profile of BDDE-crosslinked HA and its degradation products. Given the strength of the empirical evidence, physicians should be confident in offering these products to their patients.

Complications of toxins and fillers in facial aesthetics.

Dermal filler and botulinum toxin injections are among the most performed non-invasive procedures for rejuvenation and contouring, internationally. Although most dermal fillers and approved botulinum toxins are well tolerated with a high safety profile, adverse events and/or complications can happen. Injection-related sequelae and side effects are usually rare, mild, transient, and self-limiting in nature. However, devastating and life-changing complications, such as intravascular occlusion, skin necrosis, permanent visual impairment, and stroke, have been reported. Risk reduction measures include an in-depth knowledge of anatomy, physiology, and pharmacology, correct patient selection, correct identification of clinical indications, and, fundamentally, the importance of appropriate skill and training. In this paper, some of the complications are discussed and advice on how to minimise adverse events and complications from these injectables is provided.

Hyaluronic Acid Fillers and ASIA Syndrome: Case Studies.

A continuous increase in the popularity of esthetic procedures with the use of substances as HA has been observed for many years, which might be contributing to an increase in the number of adverse events. The autoimmune/inflammatory syndrome induced by adjuvants (ASIA) can be provoked by hyaluronic acid (HA), which belongs to substances meeting the criteria of adjuvants. Mechanisms of the innate and acquired immune response are activated, leading to the dysregulation of T and B lymphocytes, inability to recognize one's own antigens, inflammation, damage to one's own tissues, and ultimately to autoimmunity. The objective of this article is to present a case-series study of patients who developed ASIA syndrome following HA injection after delayed inflammatory reaction (DIR) and emphasize the importance of the need for long-term monitoring after such the reaction. Lack of knowledge about ASIA can lead to delayed diagnosis and serious consequences for the patients. People with a history of immunization reactions, severe allergic reactions, individual predisposition to autoimmunity or family predisposition to autoimmunity and previous exposure to adjuvants require special attention and long-term follow-up. This applies primarily to cases of DIR after the using of bioimplants, especially with treatment resistance, as in our reported cases.

Standards for aseptic techniques in medical aesthetic practices in the Benelux: Consensus recommendations.

INTRODUCTION: While the demand for aesthetic procedures is rising, complications are rising alongside. Infection is a frequent complication, there is therefore an increased need for strict aseptic technique, particularly in procedures breaching the skin. The level of training of practitioners carrying out these procedures varies and there are no comprehensive guidelines on aseptic aesthetic practice in the Benelux region. OBJECTIVE: Developing a step-by-step procedure for achieving and maintaining a high standard of aseptic conditions in a standard aesthetic practice in the Benelux region. METHODS: A consensus group of 10 aesthetic medical practitioners (dermatologists, plastic surgeons, and cosmetic physicians) representing the Benelux region convened to discuss best practice for aseptic techniques in medical aesthetics. Step-by-step procedures were recommended to achieve optimal aseptic practice in private facilities and define important considerations for reducing infection risk. Recommendations were based on current evidence and extensive clinical experience. RESULTS: Recommendations were made to achieve and maintain a high standard of asepsis and infection control. Guidance included maintaining high standard aseptic conditions of the injecting room, the injecting area on the patient, the injection procedure, the materials, and procedures commonly used to achieve aseptic conditions. CONCLUSIONS: This expert consensus summary publication recommends aseptic procedures, setting a standard with the goal of minimizing rates of complications in aesthetic clinical practice in the Benelux region.

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.

The 10-Point Plan 2021: Updated Concepts for Improved Procedural Safety During Facial Filler Treatments.

Dermal filler treatments require constant reassessment for improving and safeguarding the rapidly evolving aesthetic field. Suboptimal injection technique, patient selection and product knowledge have touted a concerning increase in filler complications, with new challenges such as the COVID-19 pandemic leading to new paradigms in the understanding, prevention, diagnosis and treatment of complications. The updated 10-point plan has been developed to curtail complications through consideration of causative factors, categorized as patient, product, and procedure-related. Patient-related factors include a preprocedural consultation with careful elucidation of skin conditions (acne, rosacea, dermatitis), systemic disease (allergies, autoimmune disease, underlying bacterial and viral disease (herpes simplex virus, COVID-19 infection), medications (antineoplastic drugs, recreational drugs) and previous cosmetic procedures (including fillers and energy-based devices). Patient assessment should include standardized photography and also evaluate the role of social media, ethnicity, gender, generational, and LGBTQ+ needs. Specified informed consent for both adverse events and their treatment is essential due to the increase in vascular complications, including the risk of blindness. Product-related factors include the powerful advantage of reversibility when using hyaluronic acid (HA) products. Product characteristics such as molecular weight and filler degradation should be understood. Product layering over late or minimally degradable fillers is still inadvisable due to the initial filler being teased into reactivity. Procedural factors such as consistent photographic documentation, procedural planning, aseptic non-touch technique (ANTT), knowledge of topographical anatomy and angiosomes, and technical dexterity including pinch anatomy and needle skills are of pivotal importance. The final section is dedicated to algorithms and checklists for managing and treating complications such as allergic hypersensitivity reactions, vascular events, infection, edema and late-onset adverse events (LOAEs). The updated 10-point plan is a methodical strategy aimed at further minimising the risk of dermal filler complications.

Considerations for the Use of Minimally Invasive Aesthetic Procedures for Facial Remodeling in Transgender Individuals.

There is increasing demand among transgender individuals for minimally invasive aesthetic procedures, such as injectable facial fillers and neurotoxins, for facial remodeling and transformation. These procedures may increase transgender individuals' satisfaction with their appearance and allow them to more effectively harmonize their physical appearance with their perception of self. There is currently a lack of information in the medical literature regarding guidelines for the use of these products in transgender patients. In this report, the authors provide experience-based treatment considerations and recommendations for use of minimally invasive facial aesthetic procedures in transgender patients, including case studies illustrating the use of these procedures for both male-to-female and female-to-male transitioning patients. This report highlights the success of minimally invasive methods for assisting transgender patients in achieving their facial remodeling goals. Clinicians play an integral role in the transitioning process for transgender patients, and facial transformation is a key element of this process. When conducted with sensitivity and attention to individual patient goals at varying stages of transition, facial procedures can be of great benefit in enhancing patients' self-perception and overall quality of life.

OnabotulinumtoxinA Treatment for Moderate to Severe Forehead Lines: A Review.

With onabotulinumtoxinA approved for the treatment of glabellar and crow's feet lines and, most recently, for forehead lines (FHL), it is possible to simultaneously treat multiple areas of the upper face that are of high concern and treatment priority for aesthetically oriented individuals. This review aims to present key insights on the use of onabotulinumtoxinA for the treatment of moderate to severe FHL. METHODS: Double-blind, placebo-controlled registration trials of onabotulinumtoxinA for the treatment of FHL were included. Using findings from 3 such published studies, we discuss key concepts and clinical experience for the treatment of moderate to severe FHL with onabotulinumtoxinA (20 U in the frontalis and 20 U in the glabellar complex, with/without 24 U in crow's feet lines), including injection pattern, dose selection, efficacy and safety data, and considerations for patient selection. RESULTS: Across the 2 pivotal phase 3 studies, responder rates on investigator- and subject-assessed measures of appearance of FHL severity were significantly higher with onabotulinumtoxinA versus placebo for the treatment of FHL at day 30 (P < 0.0001), and results were maintained through 3 cycles of onabotulinumtoxinA. CONCLUSIONS: OnabotulinumtoxinA treatment also resulted in high patient satisfaction rates. The incidence of eyebrow and of eyelid ptosis was low, and no new safety signals were detected. OnabotulinumtoxinA is safe and effective and an appropriate option for patients with moderate to severe FHL encountered in clinical practice.

Global Approaches to the Prevention and Management of Delayed-onset Adverse Reactions with Hyaluronic Acid-based Fillers.

BACKGROUND: Delayed-onset adverse reactions to hyaluronic acid (HA) fillers are uncommon but have received increased attention, particularly with regard to late-onset nodules. Globally, there is a need for comprehensive prevention and management strategies. METHODS: Experts with clinical practices in diverse regions of the world and extensive experience in managing complications related to HA fillers convened to propose and evaluate approaches to prevent delayed-onset adverse reactions after HA filler administration and manage late-onset nodules. RESULTS: The expert panel agreed to define delayed-onset adverse reactions as those presenting more than 4 weeks posttreatment, with swelling, induration, and nodulation being the most common clinical signs. The panel recommended 5 general key approaches for the prevention of delayed-onset reactions (patient selection, anatomic location of injection/product selection, aseptic technique, injection procedure/filler, and posttreatment care). Strategies recommended for managing late-onset nodules included oral antibiotics, oral steroids, nonsteroidal anti-inflammatory drugs if needed, hyaluronidase for noninflammatory nodules (recognizing the limitations and regional availability of this treatment), intralesional antibiotics, intralesional immunosuppressive drugs such as steroids and fluorouracil, and surgical excision as a last resort. The panel noted that late-onset nodules may vary in both clinical presentation and etiology, making them challenging to address or prevent, and stressed individualized treatment based on clinical presentation. Regional differences in aseptic protocols, antibiotic selection, and steroid formulations were described. CONCLUSION: Insights from global experts on approaches to prevent and manage delayed-onset adverse reactions following HA filler administration, including late-onset nodules, support clinicians worldwide in optimizing patient outcomes and safety.

Comparison of injection comfort of a new category of cohesive hyaluronic acid filler with preincorporated lidocaine and a hyaluronic acid filler alone.

BACKGROUND: A smooth, cohesive, 24-mg/mL hyaluronic acid (HA) gel with uniform consistency, even flow characteristics, and extended duration was designed for injection into the mid to deep dermis. OBJECTIVE: To compare injection pain of a HA gel with preincorporated lidocaine with that with a non-lidocaine formulation. METHODS & MATERIALS: This double-blind study at three centers enrolled 60 subjects, injected with both products, randomly assigned to left or right nasolabial fold. The injecting physician assessed severity of pain and ease of injection. Subjects used a visual analog scale (0-10) for pain assessment. Adverse events were recorded. RESULTS Physician assessment of injection pain was none or mild in 81% of HA gel injections with preincorporated lidocaine and 36% of HA-alone injections (p<.001). Mean pain assessment by subjects was 3.6 for HA+lidocaine and 5.8 for HA alone (p<.001). Ninety-five percent of the injections were considered easy or very easy; a greater percentage of HA+lidocaine injections were rated very easy. Mild to moderate adverse events were reported for both products. CONCLUSION: The smooth, cohesive HA gel with preincorporated lidocaine increased subject comfort during treatment and improved the injection experience.

A split-face comparison of a new hyaluronic acid facial filler containing pre-incorporated lidocaine versus a standard hyaluronic acid facial filler in the treatment of naso-labial folds.

This split-face, single-blind study compared the comfort and ease of injection of a new hyaluronic acid facial filler containing pre-incorporated lidocaine (Juvederm ULTRA 3) versus the established hyaluronic acid facial filler Restylane-Perlane. A total of 126 individuals were treated with both products, randomly assigned to the right or left naso-labial fold. Injector assessment-indicated mean injection pain, pain of massaging the injected area and post-injection discomfort (based on a scale of 0=no pain to 10=extreme pain) were 2.1, 0.9 and 0.4 for Juvederm ULTRA 3, and 4.1, 3.3 and 1.7 for Restylane-Perlane, respectively (p<0.0001). Patient assessment of the same parameters were 2.8, 1.3 and 0.4 for Juvederm ULTRA 3, and 4.9, 3.6 and 1.8 for Restylane-Perlane (p<0.0001). Injectors indicated that 92% of Juvederm ULTRA 3 injections were 'very easy', compared with 21% for Restylane-Perlane. Post-treatment smoothness was comparable, but 95% of individuals preferred Juvederm ULTRA 3 for overall injection comfort. A total of 95% of individuals indicated that Juvederm ULTRA 3 was a more comfortable and gentle experience.

Delayed hypersensitivity reaction to hyaluronic acid dermal filler following influenza-like illness.

Background: Delayed reactions after facial hyaluronic acid injection are relatively rare complications. Their cause may be infectious or immune-mediated in origin, and their outbreak can be triggered, for example, by an influenza-like illness. Objective: To describe potential adverse event of influenza like illness following dermal filler injection. Methods: We report fourteen unusual cases of delayed hypersensitivity reaction to several brands of hyaluronic acid dermal filler following influenza like illness. Results: Increasing evidence implicates influenza infection in the pathogenesis of late onset filler reaction. Conclusion: Although there is a low risk of late onset adverse reaction with hyaluronic acid fillers, injecting physicians must be aware of the possible filler reaction following the influenza infection.

The Psychological Impacts of Upper Facial Lines: A Qualitative, Patient-Centered Study.

BACKGROUND: The 11-item Facial Line Outcomes (FLO-11) questionnaire is content validated for measuring the negative psychological impacts of crow's feet lines (CFL). OBJECTIVES: The aims of this study were to determine psychological impacts of forehead lines (FHL) alone and upper facial lines (UFL: FHL + CFL + glabellar lines [GL]) and to assess adequacy of FLO-11 to measure these impacts. METHODS: Participants aged at least 18 years participated in concept elicitation and cognitive interviews to identify and define psychological impacts of UFL. They completed the FLO-11 questionnaire to assess its ability to measure psychological impacts of facial lines and its comprehensiveness in doing so. RESULTS: Forty interviews were completed by 29 participants. Twenty participants each provided interviews for FHL and for UFL. The most commonly reported psychological impacts for FHL and UFL, respectively, were feeling unattractive (85%, 80%), looking less attractive than desired (85%, 70%), feeling bothered (80%, 70%), feeling good/bad about appearance (80%, 70%), looking older than actual age (75%, 65%), and feeling stressed (70%, 70%). For FHL, 70% of participants also reported looking older than desired as a psychological impact. More than 50% of participants agreed that all 11 FLO-11 items measured a psychological impact for FHL. More than 50% reported that 9 of 11 items measured a psychological impact for UFL. The majority of participants (FHL, 65%; UFL, 60%) reported that the FLO-11 questionnaire is comprehensive in measuring psychological impacts of facial lines. CONCLUSIONS: FHL and UFL have psychological impacts on patients, and FLO-11 is a content valid, comprehensive instrument for measuring them.

Botulinum neurotoxin formulations: overcoming the confusion.

Botulinum toxin A is produced by anaerobic spore-forming bacteria and is used for various therapeutic and cosmetic purposes. Botulinum toxin A injections are the most popular nonsurgical procedure worldwide. Despite an increased demand for botulinum toxin A injections, the clinical pharmacology and differences in formulation of commonly available products are poorly understood. The various products available in the market are unique and vary in terms of units, chemical properties, biological activities, and weight, and are therefore not interchangeable. For safe clinical practice and to achieve optimal results, the practitioners need to understand the clinical issues of potency, conversion ratio, and safety issues (toxin spread and immunogenicity). In this paper, the basic clinical pharmacology of botulinum toxin A and differences between onabotulinum toxin A, abobotulinum toxin A, and incobotulinum toxin A are discussed.