Efficacy and Safety of Tapencarium (RZL-012) in Submental Fat Reduction.

BACKGROUND: Tapencarium (RZL-012) (5-(3.6-dibromo-9H-carbazol-9-yl)-N, N, N-trimethylpentan-1-aminium chloride) is a novel injectable synthetic molecule with cytolytic properties, capable of reducing subcutaneous fat volume. OBJECTIVES: The goal of this 3-armed, randomized, double-blind, placebo-controlled phase 2b study was to determine the safety and efficacy of low- and high-dose RZL-012 vs placebo on submental fat (SMF) reduction. METHODS: Patients (n = 151, age 18-65 years) with excess SMF received a single treatment session of RZL-012 or placebo in the submental area, after which they were monitored for 84 days. SMF was assessed at baseline and after dosing with newly developed scales, namely the Clinician Chin Assessment Tool (C-CAT) and Subject Chin Assessment Tool (S-CAT). SMF was also assessed by magnetic resonance imaging (MRI) at screening and on Day 84 after treatment. RESULTS: The proportion of patients who had a 1-grade or 2-grade improvement in C-CAT and/or S-CAT on Day 84 vs baseline was significantly higher in the high-dose RZL-012 group vs the placebo group (P < .002). The relative percentage reduction in MRI-measured SMF volume (Day 84 vs screening) was significantly greater in the high-dose RZL-012 group vs the low-dose RZL-012 or the placebo group (P < .0001). Local injection site reactions were the most common adverse events (AEs). CONCLUSIONS: A single administration of RZL-012 into SMF resulted in significant improvement in submental appearance as assessed by clinicians, patients, and MRI. From a safety perspective, there were no serious AEs and no clinically significant changes in vital signs or laboratory tests over the course of the study.

Photopneumatic technology for the treatment of acne vulgaris.

OBJECTIVE: Treatment of acne vulgaris with light sources necessitates multiple targets including Propionibacterium acnes and sebaceous glands. Traditional light sources such as blue light capitalize on P acnes bacteria as targets while infrared lasers and radiofrequency devices target the sebaceous gland. A novel device combining vacuum and a unique broadband light source was designed to combine multiple targets for the effective treatment of acne. The objective of this study was to demonstrate the safety and efficacy of a novel device that uses a combination of broadband light and pneumatic energy for the treatment of acne vulgaris. METHODS: In a retrospective multicenter study, clinical data were collected from 56 patients with mild to severe acne. Patients had been treated 2 to 4 times with a portable photopneumatic device (Aesthera PPx, Aesthera Corporation, Pleasanton, CA) that delivers broadband light (400 to 1200 nm) to the treatment site via a hand piece. For 11 of the 56 patients, 3 independent physicians blinded to the study treatment or duration evaluated PPx efficacy by comparing photographs taken before and after PPx treatment. RESULTS: For the 56 patients, the median physician-rated clearance increased from 50% after a single treatment to 90% after the fourth treatment, whereas the median patient-rated clearance improved from 50% after a single treatment to 78% after the fourth treatment. On a 4-point scale, both physician-rated and patient-rated median overall satisfaction levels increased from a 3 after a single treatment, to 4 after the second, third, and fourth treatments. Clinically significant adverse events were not observed. For the 11 patients evaluated by photography, the median papule and pustule lesion counts decreased from 8 to 3 and from 2 to 0, respectively. Median acne severity (Burton scale) decreased from 4 before treatment to 2 after the final treatment, and the median improvement was 4.5 (scale 1-5). The median erythema rating decreased from 2 before treatment to 1 after the final treatment (scale 1-4). Adverse events were limited to mild erythema. The median acne clearance was 3 (scale 1-4). CONCLUSION: Photopneumatic technology provides a safe and effective treatment of mild to severe acne vulgaris.