Safety and Duration of Effect of 40U PrabotulinumtoxinA-xvfs for the Treatment of Moderate to Severe Glabellar Lines in Adult Patients: A Phase II, Multi-Center, Randomized, Double Blind, Active-Controlled Trial.

BACKGROUND: Extending the duration of effect of botulinum toxins - by administering doses beyond those of the approved labels - has been an area of increasing interest in the field of aesthetics. OBJECTIVES: To investigate the safety and duration of effect of 40U prabotulinumtoxinA-xvfs (twice the approved dose and concentration) for the treatment of moderate-to-severe glabellar lines. METHODS: 154 adult patients were randomized 1:1:1 to a single treatment of either 40U prabotulinumtoxinA-xvfs (PRA 40, 5 injections of 8U/0.05 mL), or 20U of either prabotulinumtoxinA-xvfs (PRA 20) or onabotulinumtoxinA (ONA 20). Both 20U controls were administered as 5 injections of 4U/0.1 mL. Efficacy and safety were assessed on Days 2, 7 (by phone), 30 and every 30 days thereafter up to 365 days or until the patient had returned to Baseline. The primary effectiveness endpoint was the duration of effect (estimated by Kaplan-Meier analysis), defined as the number of days from Treatment Day (Baseline) to the day that glabellar line severity at maximum frown by investigator assessment returned to the baseline value. RESULTS: Patients had a mean age of 47 years (20-72 years); 69.5% had severe glabellar lines at Baseline. Of the 36 adverse events, 32 (88.9%) were mild and 4 (11.1%) were moderate in severity; none were serious. The median durations of effect were estimated to be 183, 149 and 148 days for PRA 40-, PRA 20- and ONA 20-treated patients, respectively. CONCLUSIONS: In this Phase II pilot study, 40U prabotulinumtoxinA-xvfs was observed to be safe and had a duration of 6 months.

Effectiveness and Safety of Sculptra Poly-L-Lactic Acid Injectable Implant in the Correction of Cheek Wrinkles.

BACKGROUND: The current study evaluated the effectiveness and safety of Sculptra injectable poly-L-lactic acid (PLLA-SCA) treatment in correcting cheek wrinkles compared with a no-treatment control. METHODS: Male/female immune-competent adults (aged >21 years) with moderate/severe cheek wrinkles, graded using the Galderma Cheek Wrinkle Scale (GCWS) at rest, were randomized 2:1 to receive PLLA-SCA injections (150 mg; 8 mL reconstitution in sterile water for injection) + 1 mL lidocaine hydrochloride (2%), administered immediately after reconstitution, or no treatment (control). Up to 3 additional treatments were allowed at monthly intervals, and follow-up was at months 7, 9, and 12. The primary endpoint was 1-grade or greater improvement in GCWS at rest for both cheeks at month 12. RESULTS: GCWS at rest responder rate was significantly higher with PLLA-SCA treatment versus the no-treatment control at months 7 (66.2% versus 38.6%; P=0.0043), 9 (70.6% versus 31.1%; P<0.0001), and 12 (71.6% versus 26.1%; P<0.0001). Treating investigators reported improvements in skin radiance (>95%), tighter appearance (>88%), and jawline contour (>85%). PLLA-SCA recipients reported high satisfaction levels regarding improvements in skin radiance (90% or greater), sagging (84% or greater), and firmness (91% or greater) as well as natural-looking results (85% or greater) and a desire for repeat treatment (84% or greater). Treatment-related adverse events were mostly mild in severity with no serious events related to PLLA-SCA injections. CONCLUSION: Injectable PLLA-SCA treatments were well tolerated and significantly reduced the severity of moderate/severe cheek lines and wrinkles, while improving skin quality. Effectiveness was durable over the 12-month study period with high subject-reported satisfaction, natural-looking appearance, and enthusiasm for repeat treatments. CLINICALTRIALS: gov registry number: NCT04124692J Drugs Dermatol. 2024;23(1):1297-1305.        doi:10.36849/JDD.7729.

A Randomized Trial to Assess Effectiveness and Safety of a Hyaluronic Acid Filler for Chin Augmentation and Correction of Chin Retrusion.

BACKGROUND: The chin is important for facial appearance, affecting overall balance and harmony of the face. The purpose of this study was to evaluate effectiveness of the hyaluronic acid filler Restylane Defyne for chin augmentation and correction of chin retrusion versus a no-treatment control. METHODS: Male and female subjects, aged 22 years or older, with mild to moderate chin retrusion, were randomized 3:1 to the hyaluronic acid filler Restylane Defyne ( n = 107) or no treatment ( n = 33). Assessments included live, blinded evaluations on a validated chin retrusion scale (Galderma Chin Retrusion Scale), aesthetic improvement (Global Aesthetic Improvement Scale), subject-reported FACE-Q Satisfaction with Chin, and safety follow-up. RESULTS: Galderma Chin Retrusion Scale responder rate (≥1 grade improvement) was higher for the hyaluronic acid filler Restylane Defyne (81 percent) than for control (6 percent) ( p < 0.001) at week 12, and remained higher at week 48 (74 percent versus 11 percent; p < 0.001). Aesthetic improvement rates were high throughout the study as reported by investigators (≥96 percent) and subjects (≥85 percent). Subject satisfaction was higher in the hyaluronic acid filler Restylane Defyne group than in the control group at week 12 ( p < 0.001). In the individual FACE-Q scale items, 87 to 98 percent of subjects were satisfied at week 12. Treatment-related adverse events were mild to moderate. CONCLUSIONS: The hyaluronic acid filler Restylane Defyne was safe and effective for augmentation of the chin region to improve the chin profile and associated with high aesthetic improvement and subject satisfaction. Effectiveness was sustained throughout 48 weeks. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.

Skin Tightening With Hyperdilute CaHA: Dilution Practices and Practical Guidance for Clinical Practice.

BACKGROUND: Over the past several years, hyperdilute calcium hydroxylapatite (CaHA) has emerged as an effective modality for improving skin quality and managing laxity in the face, arms, hands, neck, décolletage, upper arms, abdomen, buttocks, and upper legs, as well as for treating cellulite and striae. Whereas undiluted CaHA is used to provide volume, hyperdilute CaHA is distributed across a much larger surface area in a more superficial plane to stimulate neocollagenesis and elastin formation over time. The absence of lymphocytic infiltrates and predominance of type 1 collagen in the tissue response to CaHA make hyperdilute CaHA a valuable tool for nonsurgical skin tightening. OBJECTIVES: The aim of this study was to provide practical step-by-step guidance on patient selection, dilution practices, and optimal injection technique to facilitate incorporation of the technique into clinical practice. METHODS: Over the course of 3 regional meetings in the United States, 12 expert physician injectors participated in live webinars as part of a continuing medical education program. RESULTS: The practical guidance in this manuscript is based upon the most frequently requested information by audience members and the information considered critical for success by the authors. CONCLUSIONS: The minimally invasive nature of filler injection results in little downtime, making this treatment particularly appealing. The recommendations presented are consistent with previously published consensus guidelines on hyperdilute CaHA but are intended to serve as "how-to" guidance based on the experience of expert injectors who have successfully treated the face and body.

AbobotulinumtoxinA Treatment of Glabellar Lines Using a New Reconstitution and Injection Volume: Randomized, Placebo-Controlled Data.

BACKGROUND: Increasing the reconstitution and injection volumes of abobotulinumtoxinA (aboBoNT-A) could provide more options for aesthetic healthcare professionals. OBJECTIVE: To evaluate efficacy and safety of aboBoNT-A treatment of moderate-to-severe glabellar lines (GL) versus placebo, using a new reconstitution and injection volume. Methods & Materials: In this 6-month, Phase III, randomized, double-blind study, subjects 18-64 years were administered aboBoNT-A 50 U (N=224) or placebo (N=77), as five 0.1-mL-injections (10 U) in the glabellar region following reconstitution of a 300-U-vial in 3 mL. Assessments included time to onset of effect, investigator- (ILA) and subject- (SSA) assessed GL severity, subject satisfaction, aesthetic improvement and safety. The primary endpoint was composite 2-grade response at month 1 (a GL severity of none-or-mild at maximum frown and ≥2-grade improvement from baseline concurrently on both ILA and SSA). RESULTS: Median time to onset was 2 days, 34% of subjects reporting effect on day 1. At month 1, the composite 2-grade responder rate was 65.8% for aboBoNT-A versus 0% for placebo, P<0.001, 91–92% had none-or-mild GL severity, and 95–100% had a ≥1-grade GL severity improvement. A ≥1-grade improvement was sustained in 46-56% of aboBoNT-A-treated subjects up to 6 months (P<0.001 vs placebo). Aesthetic improvement and subject satisfaction were high throughout 6 months and aboBoNT-A treatment was well tolerated. CONCLUSION: Safety and efficacy of GL treatment using 0.1 mL (10 U) aboBoNT-A per injection site were demonstrated, with rapid onset and up to 6 months’ duration of effect. Severity improvement was accompanied by sustained aesthetic improvement and subject satisfaction. J Drugs Dermatol. 2021;20(9):988-995. doi:10.36849/JDD.6130.

Cryolipolysis: Clinical Best Practices and Other Nonclinical Considerations.

Cryolipolysis is a nonsurgical body contouring procedure that involves cooling of fat cells to induce lipolysis while sparing surrounding structures. Plastic surgery practices are increasingly incorporating noninvasive aesthetic procedures (eg, cryolipolysis, fillers, radiofrequency, ultrasound) to offer their patients a wider range of aesthetic treatment options. Here, we report insights from 8 plastic surgeons with regard to cryolipolysis best practices from a clinical perspective and the impact of integrating this noninvasive body contouring procedure into a plastic surgery practice. The authors prefer cryolipolysis over liposuction for patients who are not amenable to surgery or those who desire to avoid downtime, also taking into consideration body mass index, skin laxity, comorbidities, and risk of contour irregularities. Patient counseling is critical for setting realistic expectations regarding outcomes and should focus on the efficacy of cryolipolysis, individual variability in results, potential side effects, time course of treatment response, and the need for multiple treatment cycles. Strategies for reaching new patients and expanding services among current cryolipolysis patients are discussed.

Bilateral vocal fold paresis after endoscopic stapling diverticulotomy for Zenker's diverticulum.

BACKGROUND: Zenker's diverticulum may be treated with a variety of surgical techniques. Endoscopic methods, specifically endoscopic stapling diverticulotomy, have gained increasing acceptance because of shorter operative times, decreased morbidity, with shorter hospital stays and time to resumption of oral feedings. METHODS AND RESULTS: We report the occurrence of bilateral vocal fold paresis after endoscopic stapling diverticulotomy for Zenker's diverticulum, previously unreported in the literature. This complication likely resulted from traction on the recurrent laryngeal nerves secondary to unfavorable patient anatomy. CONCLUSIONS: Endoscopic stapling diverticulotomy is a safe and effective treatment method for Zenker's diverticulum and remains our procedure of choice for most patients. However, inability to safely expose the diverticulum endoscopically results in a significant abandonment rate for attempted procedures and may result in significant postoperative complications.