BACKGROUND RelabotulinumtoxinA (RelaBoNT-A) is a complex-free, ready-to-use, liquid botulinum toxin A. OBJECTIVE Efficacy/safety of RelaBoNT-A treatment for lateral canthal lines (LCL). METHODS Randomized adults received RelaBoNT-A (30 U/side; n = 230) or placebo (n = 73) during a 6-month, double-blind, Ph3 study (Relabotulinumtoxin Aesthetic Development Study-2 [READY-2]). Primary end points (Month 1, maximum smile) comprised: composite ≥2-grade responder rate using concurrent LCL severity investigator live assessment (LCL-ILA) and subject live assessment (LCL-SLA); LCL-ILA 0 (none)/1 (mild) responder rate. Subject satisfaction and adverse events were also reported. RESULTS Month 1 composite ≥2-grade responder rates were 51.8% (RelaBoNT-A) and 1.4% (placebo; (p < .001). Month 1 none/mild LCL-ILA responder rates were 87.2% (RelaBoNT-A) and 11.9% (placebo; p < .001). Onset was reported Day 1 by 34%. At Month 6, LCL-ILA responder rates for RelaBoNT-A remained at 23.3% (none/mild) and 35.9% (≥1-grade improvement). Median return to baseline severity was 24.7 weeks; 64% (RelaBoNT-A group) had not returned to baseline at Month 6. RelaBoNT-A satisfaction was high through Month 6 (71%). Mild/moderate treatment-related adverse events occurred in 6.1% (RelaBoNT-A) and 5.5% (placebo). CONCLUSION RelaBoNT-A (60 U) treatment provided statistically significant improvement of moderate-to-severe LCL. One-third of subjects reported onset within 1 day and improvements were maintained through Month 6. Treatment satisfaction was high. RelaBoNT-A was well tolerated.
A Unified Approach to Facial Contours and Volume Correction: The Role of the Cheek and the Chin
Background:Facial proportions and contours influence perceptions of beauty and youthfulness. In particular, the shape and definition of the midface and lower face impact the overall appearance of the face.Methods:This review provides anatomical evidence to support a holistic approach to facial analysis and rejuvenation that starts with assessment and treatment of the midface and lower face to create an aesthetically desirable facial balance.Results:The cheek and chin can be considered “anchors” or starting points within full-face treatment because of the noticeable impact of their treatment on the definition and contour of the entire face. Age-related changes in the cheek and chin affect overall facial appearance and can produce unintended facial emotional attributes such as looking tired, angry, or sad. Patients seek facial aesthetic treatment typically for a global improvement such as revitalization or genderization of facial features. Best practices in aesthetics have evolved from treatment of individual areas to a holistic paradigm that uses multimodal therapy to improve overall facial emotional attributes. Hyaluronic acid fillers are useful for volume replacement and smoothing abrupt transitions that develop with age throughout the midface, chin, and jaw. A combination of hyaluronic acid filler for volume restoration and sodium deoxycholate and/or onabotulinumtoxinA for volume reduction where appropriate may optimize lower facial contour.Conclusions:This review highlights the importance of facial angles and contours as well as the significance of panfacial assessments and treatment, focusing on the relationships within areas of the face, specifically the midface and lower face, to optimize results.
From Nasolabial Folds to Pan-facial Rejuvenation—The Evolution of Fillers in my Career
AbstractThis is a comprehensive review of facial fillers including landmark studies and expert commentary spanning the years from 2003 (when the first hyaluronic acid [HA] dermal filler underwent Food and Drug Administration approval in United States) to present.
One-Year Data on the Longevity and Safety of Hyaluronic Acid Filler for Static Horizontal Neck Rhytids
BACKGROUND The long-term efficacy and safety of hyaluronic acid fillers injected into the neck have yet to be analyzed in a prospective trial in the United States. OBJECTIVE Analyze the long-term efficacy and safety of a hyaluronic acid filler for static horizontal neck rhytids. MATERIALS AND METHODS Twenty-six subjects were enrolled in the study. Six subjects were randomized to receive saline and 20 subjects were randomized to receive HARR. All subjects were randomized to use a cannula on 1 side and needle on the other with optional retreatment on day 30 and optional crossover treatment with different assignment on day 60. The subjects were graded using the Transverse Neck Line Scale, Canfield photography, and the Global Aesthetic Improvement Scale on day 360. RESULTS A significant improvement from baseline on day 360 was achieved on the Transverse Neck Line Scale according to the blind evaluator, subjects, and investigator without any delayed-onset or prolonged side effects. There was no significant difference in the average improvement from the short-term analysis on day 60 to the long-term analysis on day 360. CONCLUSION HARR achieved significant long-term improvement in static horizontal neck rhytids without any long-term side effects.
Cosmetic Filler and PET Positivity: The Risk of a False Positive
ObjectiveTo discuss a case of hyaluronic acid filler displaying as PET avid resulting in a false positive for local recurrence and review of the literature of how filler presents on PET.Study DesignCase report and literature review.MethodsRetrospective case review of a patient with angiosarcoma with PET‐MRI positivity after hyaluronic acid filler injection. Review of the literature was performed.ResultsA 49‐year‐old female with low grade angiosarcoma of the right cheek pT1N0M0 was treated with wide local excision and staged reconstruction with cervicofacial advancement flap with subsequent adjuvant radiation therapy. Surveillance PET/MRI scans were conducted every 3 months. After one year without recurrence, HA injectable filler was offered to correct resultant right facial soft tissue defect. The patient proceeded with HA filler and was counseled on the risk of local increased SUV on imaging. Her PET/MRI 3 months later revealed postsurgical changes in the right premaxillary soft tissues with associated low‐grade hypermetabolism with max SUV 1.8, which elevated from prior max SUV 0.9. Contralateral left maxillary soft tissues revealed max SUV 0.8. Biopsy was initially favored for concern of local recurrence until the potential for filler to be associated with elevated SUV was discussed. Further evaluation with MRI showed diffusely increased T2 signal with some trace enhancement in the region of PET activity, confirming that findings were consistent with HA filler augmentation per the neuroradiologist team.ConclusionsFillers, including hyaluronic acid, are associated with elevated SUV on PET‐CT. Otolaryngologists should be aware of these features to improve patient counseling, avoid unnecessary procedures, and reduce patient anxiety. Laryngoscope, 133:2951–2953, 2023
Actinomyces: An Under Appreciated Cause of Postoperative Infection in Rhinoplasty
ObjectiveTo discuss a case series of Actinomyces infection post‐rhinoplasty and review the literature for correct diagnosis and management.Study DesignCase series with chart review.MethodsThree cases are presented of patients with a history of recurrent infectious symptoms post revision rhinoplasty later being diagnosed as Actinomyces.ResultsThree patients were identified having undergone revision rhinoplasty and later being diagnosed with Actinomyces infection. They initially presented with underwhelming physical exams, mild erythema, slight swelling, yet extreme pain. They also had periods of recurrent infection once antibiotics were stopped. Aerobic, anaerobic, fungal, and Actinomyces cultures were sent to pathology and returned positive for Actinomyces. Treatment typically involved a combination of prolonged antibiotics, incision and drainage, and/or surgical debridement.ConclusionsAwareness of Actinomyces as a possible cause of infection post‐rhinoplasty is significant as this pathogen can lead to extensive tissue destruction and fistula formation which could be detrimental for a rhinoplasty. Duration of treatment is beyond typical lengths for other infections and a specific culture for Actinomyces is required to be sent as it isn't captured in standard aerobic/anaerobic cultures. Therefore, a high index of suspicion is required by physicians to ensure that patients are evaluated thoroughly. Laryngoscope, 133:2948–2950, 2023
Incobotulinum toxin A: A shelf‐stable, low‐molecular‐weight formulation
AbstractSince its development in 2005, incobotulinum toxin A (INCO) has become one of the most widely used neurotoxins worldwide for aesthetic and therapeutic indications. It was initially designed as a formulation free of complex proteins for reduced immunogenicity with an equal action and strength profile to the original and widespread onabotulinum toxin A (ONA). Multiple trials have demonstrated equivalent efficacy. Several studies have suggested a slight decrease in the time of visible treatment onset with INCO and a subsequent lack of difference in duration of effects when compared with ONA. Particularly appreciable with therapeutic doses, utilization of INCO led to significant cost savings over ONA or abobotulinum toxin A. Karschney et al. found that for the treatment of cervical dystonia and chronic migraine the cost to patients was reduced by 32.2% compared to ONA. Additionally, the ONA formulation allows for long‐term storage at room temperature along with an increased stability time once reconstituted. Limitations of INCO include a similar side effect profile to other neurotoxin formulations, more likely at therapeutic dosing. Indications approved by the Federal Drug Administration in the United States and other regulatory agencies are currently more limited than those of ONA, though this may be in direct relation to the length of time on the market. INCO has overall been demonstrated to be a safe, efficacious alternative to other common neurotoxin formulations.
Asplit‐face, blind, randomized placebo‐controlled clinical trial investigating the efficacy and safety of hyaluronic acid filler for the correction of atrophic facial scars
AbstractBackgroundHyaluronic acid fillers have been studied extensively for facial wrinkles; however, their efficacy for atrophic facial scars has yet to be analyzed in a prospective placebo‐controlled study.ObjectiveTo analyze the efficacy and safety of a hyaluronic acid filler for atrophic facial scars.Methods & MaterialsFifteen subjects were randomized to receive up to 1 ml of VYC‐17.5 L on one cheek and up to 1 ml of saline on the other side, with an optional touch‐up treatment. Subjects were graded by a live blind evaluator using the Quantitative Global Scarring Grading System (QGSGS) (J Cosmet Dermatol. 2006;5:48), the Global Aesthetic Improvement Scale (GAIS), and Canfield photo‐analysis.ResultsAccording to the blind evaluator, there was a significant reduction 90 days after the last treatment on the QGSGS for VYC‐17.5L compared with saline (−6.6 VYC‐17.5L vs −1.7 saline [t(28) = −4.3196,p = 0.008]). There was a smaller, but still significant reduction on the QGSGS for saline alone (10.4 to 8.6 [t(14) = −3.453,p = 0.004]). In addition, 93% (13/14) of subjects chose VYC‐17.5L over saline treatment and reported an improvement on the GAIS. There were no serious side effects and all minor side effects resolved by Day 30.ConclusionVYC‐17.5L achieved significant improvements in rolling atrophic scars as compared to saline, though saline also had modest improvements.