Two randomized studies to evaluate the cooling sensation, consumer liking, and tolerability of a skin disinfectant spray.

Abstract

The aim of these two clinical studies was to evaluate the sensory characteristics and irritation potential of a prototype disinfectant spray (containing 0.13% w/v benzalkonium chloride and a cooling agent) in subjects with experimental wounds. The pilot study was a single center, "replicated latinClinicalTrials.ClinicalTrials. square design," randomized and double-blinded study. The pivotal study was a single center, randomized, controlled, crossover, double-blinded study, following a direct comparison test design of the study products. The experimental wounds were generated using sequential tape strippings of the forearm skin before product application. The test product was compared with the currently marketed BACTROBAN® disinfectant spray, negative control (0.9% w/v saline), and positive control (70% w/v isopropyl alcohol, pilot study only). The pilot study was intended to inform the study design and sample size for the pivotal study. The pilot study demonstrated that the positive control product delivered significantly more irritancy (stinging /burning sensory) than the negative control product on the experimental wound, which verified the integrity of the wound model. The results of the pivotal study suggested that the prototype formulation delivered significantly more cooling sensation than both BACTROBAN® disinfectant spray and negative control at 3 and 5 min after product application, and overall for a 15-min period after application. No statistically significant differences in product liking were observed between the prototype disinfectant spray and the BACTROBAN® disinfectant spray or negative control. The prototype disinfectant spray, BACTROBAN® disinfectant spray, and control products were well-tolerated in these studies.