Efficacy of a Novel Injection Lipolysis to Induce Targeted Adipocyte Apoptosis: A Randomized, Phase IIa Study of CBL-514 Injection on Abdominal Subcutaneous Fat Reduction.

BACKGROUND: CBL-514 is a novel injectable drug that may be safe and efficacious for localized abdominal subcutaneous fat reduction. OBJECTIVES: The aim of this study was to assess the safety and efficacy of CBL-514 in reducing abdominal subcutaneous fat volume and thickness. METHODS: This Phase IIa, open-label, random allocation study consisted of a 6-week treatment period and follow-up at 4 and 8 weeks following the last treatment. Participants were randomly allocated to receive 1.2 mg/cm2 (180 mg), 1.6 mg/cm2 (240 mg), or 2.0 mg/cm2 (300 mg) of CBL-514 with up to 4 treatments, each comprising 60 injections into the abdominal adipose layer. Changes in abdominal subcutaneous fat were assessed by ultrasound at follow-up visits. Treatment-emergent adverse events were recorded. RESULTS: Higher doses of CBL-514 (unit dose, 2.0 and 1.6 mg/cm2) significantly improved the absolute and percentage reduction in abdominal fat volume (P < 0.00001) and thickness (P < 0.0001) compared with baseline. Although the COVID-19 pandemic halted some participant recruitment and follow-ups, analysis was unaffected, even after sample size limitations. CONCLUSIONS: CBL-514 injection at multiple doses up to 300 mg with a unit dose of 2.0 mg/cm2 is safe, well-tolerated, and reduced abdominal fat volume and thickness by inducing adipocyte apoptosis. Although other procedures exist to treat abdominal fat, they have limitations and may cause complications. At a dose of 2.0 mg/cm2, CBL-514 safely and significantly reduced abdominal fat volume by 24.96%, making it a promising new treatment for routine, nonsurgical abdominal fat reduction in dermatologic clinics.

Why we should be avoiding periorificial mimetic muscles when injecting tissue fillers.

BACKGROUND: Tissue fillers are generally safe and well tolerated by patients. However, complications do occur and may be very severe, such as intravascular injection (with occasional residual tissue loss, visual and neurological sequelae) and late nodularity and swelling. Methods to lessen the likelihood of complications have been the subject of much recent literature. Depth of injection has been identified as a key safety consideration. PATIENTS/METHODS: The role of injection of facial filler into the muscular layer of the face is explored in this article. Literature was explored using available search facilities to study the role of injections in or around this layer in the production of significant adverse reactions. RESULTS: A body of literature seems to suggest that injection into mimetic musculature of the face especially the musculature in the periorbital and perioral regions is prone to adverse reactions. CONCLUSIONS: Injection of agents into the perioral and periorbital mimetic muscular layer may produce, product clumping, displacement, and tendency to late nodularity and swelling. It also risks intravascular injection as compared to injection of other layers of the face. Injection into the mimetic muscles especially the sphincteric muscles should be avoided to minimize the risk of complications.

Re Facial aesthetic injections in clinical practice: Pretreatment and post-treatment consensus recommendations to minimise adverse outcome Region-specific changes in line with the Covid-19 pandemic.

Despite the recent publication in March 2020 of guidelines for facial injectable treatments, the speed of the COVID-19 pandemic and its safety implications necessitate changes to these guidelines The authors described what would constitute safest practice in the provision of facial injectable treatments and summarised these in table form. Adherence to a high standard of asepsis and infectious disease precautions remain a key patient safety requirement when performing facial aesthetic injections. A revision and update of these guideline summary tables follows. Changes made should enhance both patient and staff safety regarding COVID-19/SARS-CoV-2, a highly infective respiratory pathogen transmitted by respiratory droplets, respiratory/mucosal secretions and contaminated fomites. Some of the additions are COVID-19 specific and are likely to evolve and change, particularly should serological tests determining acquired immunity become available. Other additions represent further tightening of our infection control precautions.