Tapencarium (RZL-012) for Flank Fat Reduction: A Proof-of-Concept Study.

Background: RZL-012 is a novel cytolytic drug that has shown promise in reducing localized fat deposits in a single treatment session. Objectives: To assess the safety and efficacy of injecting RZL-012 to the flanks. Methods: A double-blind, placebo-controlled, proof of concept study randomized 12 patients to receive RZL-012 injections in 1 flank and placebo injections in the contralateral flank. After 12 weeks of follow-up, patients could receive RZL-012 in the placebo-treated flank and undergo follow-up for 12 weeks in the open-label phase. Results: At 12 weeks, Investigator Global Aesthetic Improvement Scale assessments showed improvement for 90.9% of RZL-012-treated flanks and 0% of placebo-treated flanks (P < .0001), 81.8% of patients were satisfied with the RZL-012-treated flanks, and 9.1% were satisfied with the placebo-treated flanks (P = .0019). Volume reduction measured on 3-dimensional images was a mean 37.27 mL, which was significantly greater than placebo (P = .0052). The product was well tolerated, with no clinically significant trends in laboratory values, electrocardiograms, or vital signs. Pharmacokinetic analyses demonstrated that RZL-012 is quickly absorbed, reaches maximum concentration in approximately 1.67 h, and has a half-life of 9.1 h. The mean maximal concentration of RZL-012 found in the blood was <1 µg/mL. Conclusions: RZL-012 is a promising option for injectable fat reduction of the flanks in a single treatment session. The drug was well tolerated in this small patient population, with no concerning safety signals, and it had indications of efficacy. Further research is needed in large Phase 2 studies with robust efficacy measurements to confirm these early findings.

Real-World Experience With Collagenase Clostridium Histolyticum-aaes for Buttock and Thigh Cellulite: Focus on Administration and Safety Profile.

Background: Collagenase clostridium histolyticum-aaes (CCH-aaes) is approved for the treatment of moderate-to-severe buttock cellulite in adult women. Objectives: To report on real-world experience with CCH-aaes in the treatment of buttock and thigh cellulite. Methods: Retrospective analysis of medical records from a single treatment center. Results: The population comprised 28 consecutively treated women; mean age was 40.5 years (range, 23-56 years) and mean body mass index was 25.9 kg/m2 (range, 19.6-41.0 kg/m2). Treatment areas were buttocks only (78.6% of patients), thighs only (10.7%), or both buttocks and thighs (10.7%). Most patients (89.3%) were treated in 2 areas (buttocks or thighs) at each visit; however, 3 patients were treated in 4 areas. At each session, the CCH-aaes dose was 0.07 mg per dimple (0.3 mL of 0.23 mg/mL for buttock cellulite; 1.5 mL of 0.046 mg/mL for thigh cellulite). The mean number of treatment sessions was 2.6 (range, 1-4) for buttock cellulite and 2.5 (range 1-3) for thigh cellulite. The mean number of dimples treated was 11.5 (range, 3-17) per buttock, 11.0 (range, 1-14) per thigh, and 23.4 (range, 8-32) overall per treatment session. Injection site-related adverse events of special interest were experienced by all 28 patients: bruising (100%), edema (96.4%), tenderness (85.7%), nodules (39.3%), pruritus (32.1%), and hyperpigmentation indicative of hemosiderin staining (7.1%). Mean duration of injection-site bruising was 8.8 days (range, 2-15 days). Conclusions: CCH-aaes is an effective, well-tolerated, minimally invasive treatment option for buttock and thigh cellulite in women.

Injection Adipocytolysis for Body and Jawline Contouring: Real-World Experience and Treatment Considerations.

BACKGROUND: The role of ATX-101 in submental fat reduction has been well documented; however, its applicability across multiple anatomic areas is to be explored. OBJECTIVES: The authors sought to describe the experience with ATX-101 subcutaneous injections for body and jawline contouring and evaluate its safety. METHODS: This single-arm, single-center observational study included 201 patients who underwent injection adipocytolysis with ATX-101 (area-adjusted dose of 2 mg/cm2) in the jowl, abdomen (upper/lower), thigh (inner/outer/banana roll), arm, anterior periaxillary fat, back (lower/upper/nape/lipoma), knee (anterior/medial), chest, and/or neck. The number of treatment sessions, treatment volumes, doses, injections required for each anatomic area, and associated adverse events were recorded. RESULTS: The mean number of treatment sessions conducted was 1.8. Multiple sessions were common for the jowl (mean: 2.0 and mean volume administered varied significantly between persons receiving 1 or multiple sessions [P = 0.005]). The mean volume and mean number of injections per session were highest in the chest (84.7 mL and 423.5, respectively) and lowest in the jowl (0.8 mL and 4.6, respectively). The chest (0.2 mL) and nape (0.2 mL) received the highest mean ATX-101 dose per injection site per session, whereas the inner thigh (0.11 mL) and upper back (0.11 mL) received the least. Adverse events observed were localized to the injection site. All patients experienced edema after each session, whereas numbness, tenderness, bruising, and paresis were experienced by 99.6%, 94.2%, 33.1%, and 2.6% of patients, respectively. Alopecia was not observed. CONCLUSIONS: ATX-101 was well tolerated for body and jawline contouring.

Safety of Helium-based Plasma Technology for Coagulation of Soft Tissue: A Retrospective Review.

Background: The subdermal application of energy using a helium-based plasma radiofrequency (RF) device has been shown to improve skin laxity. Helium-based plasma RF technology (Renuvion; Apyx Medical, Clearwater, FL) utilizes RF to ionize helium into an electrically conductive plasma capable of coagulating and contracting soft tissue with high precision and minimal thermal spread. This study provides information on the early use of the new generation of electrosurgical generator (APYX-RS3) containing a feature that allows for quantification of the amount of energy delivered to tissue during treatments. Objectives: To collate procedure details, treatment settings, and safety data in patients treated with a helium-based plasma device for soft tissue coagulation. Methods: A retrospective review was conducted of patients aged ≥ 18 years who underwent treatment with a helium-based plasma RF device (Renuvion) for soft tissue coagulation. Demographic data, procedure details, and adverse events were collected. Results: Chart review identified 47 patients with an average age of 45 years and an average BMI of 25.8 kg/m2. The amount of energy (J) delivered per treatment area was greatest for abdomen, buttocks, and thighs, with an average of 13.7 kJ, 13.5 kJ, and 10.6 kJ, respectively. No serious, unexpected, or device-related AEs were reported. Conclusions: The use of the generator that quantifies the energy (joules) being applied during the procedure allows the provider to understand and optimize their energy usage. While further research is needed to establish the safety and efficacy of the device for skin tightening, this study provides important information regarding energy application.