In Japanese patients, most basal cell carcinomas (BCCs) have pigmentation therefore, it is relatively easy to evaluate the tumor borders. We often determine narrower side margins than the current Japanese BCC guidelines. The aim of this study is to evaluate the accuracy of side margins in patients with BCC which was determined by their dermato-oncologist and to clarify the appropriate side margins for Japanese patients with BCC. We retrospectively analyzed 282 BCC specimens between 2008 to 2017 in our institution. The maximum distance differences obtained by subtracting the histological distance from the tumor border to the side edge from the preoperative side margins were measured as "accuracy gaps" of side margins. Based on the accuracy gaps, the histograms were drawn and the estimated negative margin rates (ENMRs) with narrower (2- and 3-mm) side margins were calculated. The ENMRs were 95.3% in 2 mm side margins and 98.2% in 3 mm side margins. Subgroup analysis indicates that high ENMRs will be obtained with 2-mm in low-risk group and 3-mm side margins in tumors with poorly-defined clinical borders, non-pigmented subtype and aggressive clinical subtype.
Because of government policy, the market share of generic topical products is rapidly growing in Japan, because biologic equivalence assessment in human is not required for approval of these generic products. We questioned whether generic topical products, especially moisturizers, are as effective as the reference products when used in humans with sweating capacity. We recently reported that the reference heparinoid-containing moisturizing cream (oil in water type) has a potent capacity to maintain skin surface hydration by persistently increasing basal sweating responses in humans, as compared with other moisturizers. In this study using impression mold technique, we examined whether the generic heparinoid products have effects on the basal sweating capacity similar to those of the reference products. We found that generic heparinoid-containing moisturizing cream did not significantly increase basal sweating responses or skin surface hydration at the application site, unlike the reference cream. For the bioequivalence assessment of generic topical moisturizers, the capacity of increasing basal sweating responses should be examined in addition to multiple bioequivalence tests in humans.