Additional instruction (refer to instructions code 96093/WAG r. 00 181023)
12. SUMMARY OF CLINICAL TESTS
A randomized, double-blind, placebo-controlled study was conducted on a sample of 100 patients aged from 18 to 65 years, divided in two groups: test group (subjects who used the actual test device) and placebo group (subjects who used a sham device). Results demonstrated that the device is able to reduce itching and swelling up to 1 hour.
12.1 Definition of success
Success was defined as the reduction of itching and swelling after mosquito bite in the test group compared to the placebo group.
12.2 Measurement of itching
The degree of itching for the mosquito bite was evaluated using the VAS scale (Visual Analogue Scale for pain) made with 11 quadrates numerated from 0 (no itching) to 10 (severe itching).
12.3 Evaluation of results
The primary efficacy outcome measure was a statistically significant difference in the change in VAS itching rating from 1-10 minutes to 1 hour after the mosquito bite onset.
The clinical study had a double-blind design, such that neither the subject nor the Investigator or the Monitor were aware of to which group (test or placebo) the subject had been assigned.
12.5 Potential for placebo effect
The study was placebo-controlled. The sham device was designed to have the identical physical appearance as the actual device. Nearly all study participants guessed correctly whether they were using either the real device or the sham device. Therefore, the possibility exists that there was some bias introduced based on the perceived physical sensation received with the test group versus the lack of physical sensation in the placebo group.