Safety and Efficacy of VP-102 (Cantharidin, 0.7% w/v) in Molluscum Contagiosum by Body Region: Post hoc Pooled Analyses from Two Phase III Randomized Trials.

TRIAL REGISTRATION: >ClinicalTrials.gov identifier nos. NCT03377790 (for CAMP-1) and NCT03377803 (for CAMP-2). BACKGROUND: VP-102 is drug-device combination product containing cantharidin (0.7% w/v) and has undergone Phase III clinical trials for the treatment of molluscum contagiosum (molluscum). Efficacy and safety may differ by body region due to variable skin anatomy. OBJECTIVE: We investigated the pooled safety and efficacy of VP-102 by affected body region. METHODS: Individuals at least two years of age with molluscum were randomized to topical VP-102 or vehicle once every 21 days until clear (maximum of four applications). Participants were assigned to body region groups where lesions were present at baseline. Body region lesion counts were recorded at each visit. Efficacy was measured by the percentage of participants with complete clearance of lesions by region. Pre-specified adverse events (AEs) were analyzed for those treated in the region on that visit. RESULTS: Participants had a mean of two regions affected at baseline. Complete clearance was significantly higher in the VP-102-treated group than with vehicle application in all regions at the last visit (P<0.01 for each region). The incidence of pre-specified AEs was consistent across regions. However, these analyses were post hoc, and individual lesions were not tracked for efficacy. CONCLUSION: VP-102 treatment shows consistent safety and efficacy across molluscum body regions.

Inhibition of bacterial attachment and biofilm formation by a novel intravenous catheter material using an in vitro percutaneous catheter insertion model.

INTRODUCTION: Despite sterile barrier precautions and vigorous skin antisepsis, percutaneous insertion of intravenous catheters has been shown to result in attachment to the catheter surface of bacteria residing in the deep structures of the skin. Such attachment poses the risk of biofilm formation and eventual catheter-related bloodstream infection (CRBSI). This study was undertaken to assess whether the non-coated surface treatment of a unique catheter material (ChronoFlex C® with BioGUARD™) could inhibit bacterial attachment and biofilm formation. METHODS: A novel in vitro model and fluorescence microscopy were used to compare two intravascular catheter materials with respect to bacterial attachment and biofilm formation. The control material was a commonly used polyurethane. The study material was a unique copolymer, treated so as to remove surface additives, alter hydrophobicity and create surface micro-patterning. Outcomes were assessed using both a membrane potential indicator and a cell death reporter with appropriate fluorescent channels. Thus, bacterial cells attached to the catheter surface (living and dead) were imaged without mechanical disruption. RESULTS: Both bacterial attachment and biofilm formation are significantly inhibited by the study catheter material. In fact, over 5 times more bacteria were able to attach and grow on the control polyurethane material than on the study material (P=0.0020). Moreover, those few bacteria that were able to attach to the study material had a 1.5 times greater likelihood of dying. CONCLUSION: Using a novel in vitro percutaneous catheter insertion model, ChronoFlex C with BioGUARD is proven to significantly inhibit bacterial attachment and biofilm formation as compared with a commonly used polyurethane catheter material.