Procedures for gentleness study
Nelson
NELSON, CORTEX
This was a 1‐day study in which subjects remained at the clinic for approximately 10 h.TEWL measurements were made using a recently calibrated cyberDERM RG1 Evaporimeter System (Broomall, PA) with dual TEWL Probes that were manufactured by Cortex Technology (Hadsund, Denmark) and available in the US through cyberDERM, Inc. (Media, PA). All the measurements were performed in an environmentally controlled room with temperature at 20–22°C and relative humidity at 40%–60%. Measurements were taken after a 30‐min acclimatization period, with the test areas on the volar forearm fully exposed. The TEWL rate was calculated as the average value over a 20 s period after steady‐state conditions had been reached.Measurements were made on the five (5) sites that have been mapped out on each arm as labeled in Figure Physical location of the 10 labeled measurement sites with their specific designations. The red circles represent footprint of the paired trans‐epidermal water loss (TEWL) probes within each measurement area.TEWL measurements were taken at the following time points:
T0: Baseline (prior to the first application)T1: After 4 h of wear (1st application of devices)T2: After 4 h of wear (2nd application of devices)At T1, after the devices had been worn for approximately 4 h, the devices were manually removed and retained for reapplication for the second wear period. After the 30‐min post‐removal TEWL measurements were completed, the same devices were reapplied to the same sites as at the baseline visit. Approximately 25% of the MaxN sensors showed some signs of lifting while this never was a problem with the OxySoftN sensors. In a few cases, there were concerns that the MaxN device may become detached completely, and these sensors were replaced during the second wear period. At T2, the devices were again manually removed and then sent to Nelson Labs (Salt Lake City, UT), where the total amount of protein adhered to each device was determined using the Micro BCA