Symptomatic treatment of mosquito bites with a thermo-therapeutic medical device: a prospective, intraindividual compared, placebo-controlled, randomized clinical trial

Abstract

Objective: Agonizing itching (pruritus), heat, and burning are common symptoms of mosquito bites. In this study, we present a thermo-therapeutic medical device for the symptomatic treatment of mosquito bites. Current research suggests the potential of a thermal (heat) stimulus for pruriceptor counter-stimulation and reduced histamine-signaling to relieve the symptoms of mosquito bites. The purpose of this clinical investigation was to investigate the efficacy and safety of the thermo-therapeutic medical device (class II) in the symptomatic treatment of mosquito bites in an intraindividual comparison to a placebo device (PD) examined under standardized conditions. This was achieved by assessing pruritus and wheal size over time after induction of a mosquito bite on the volar forearm. Methods: The itching was rated on a Visual Analog Scale ranging from 0 mm (no itching) to 100 mm (worst imaginable itching). The wheal size was measured in approximation to the area of an eclipse before and ~30 minutes after the treatment with the investigational device. Local tolerability was assessed by the investigator according to a score ranging from 0 (no irritation) to 4 (very strong irritation) and the subjects stated if the itching sensation was completely gone after treatment (yes/no question). Results: The mean area under the curve of the difference to baseline for the treatment with the medical device was statistically significantly bigger than for the treatment with the PD (1311.71 vs 914.61, respectively; P = 0.0127). Conclusions: Treatment of a mosquito bite with a thermo-therapeutic medical device significantly reduced pruritus and led to a faster reduction of the itching sensation as compared with PD. A significant itch reduction started immediately (1 min) after treatment with the medical device (post hoc analysis). The treatment with the medical device was well tolerated by all subjects and no adverse events related to the medical device occurred.