application compared to initial state. During the course of the study, 90% of the subjects showed a decrease in frequency or total absence of diaper dermatitis (Table 2 and Figure 1).The product was well-tolerated with no adverse effects reported during the study. The statistical analysis used the Wilcoxon’s test for paired series, for the intragroup evaluations comparison: the statistical treatment consists in determining if there is a significant difference between the individual data collected for the different evaluation times.
Wilcoxon’s Test (two paired samples)
The Wilcoxon’s test is a non parametric test allowing the comparison between two paired samples, in this case between the initial report at day 0 and the final report after day 28 (Table 3).The secondary endpoint was cosmetic acceptability and user perception of the product. One-hundred percent of users rated the product to have a pleasant texture, a good protective effect, spreads easily and does not irritate the skin. The scent was judged as pleasant (95%), and for 75% of those applying, the product texture was described as non-oily. Ease of use was notable for 100% of respondents reporting that “the product acts gently”, while 93% of respondents reported “the product ensures a daily protection against the diaper rash” (Table 4).The analysis of the daily report logs concerns the occurrence of diaper rash episodes with an intensity scoring, and the reporting of teething or diarrhea. The results show, each week, a steady decrease of the number of teething (from 109 to 57), of diarrhea (from 23 to 5), and of diaper rash episodes (from 68 to 18). Similarly, concerning the declared diaper rash intensity, the average decreases from 0.6 to 0.1. Furthermore, the subjects’ distribution by intensity level shows an increase of the population in the weakest level (null intensity: from 52% to 88% of the subjects) and a decrease of the population in the moderate level (from 12% to 3%). These results support the evidence of the product’s protective effect. An analysis of the preventive effect on the diaper rashes has also been carried out by comparison of the initial data “without product application” (ie, 4-week period prior to inclusion) with the final data “with product application” (after the 4-week application period). The results show a decrease of the cumulative number of episodes, observed on the 60 subjects sample (from 248 to 83), a decrease of the episode frequency (from 4.1 to 1.4), and a decrease of the average diaper rash intensity (from 1.5 to 0.7). The statistical comparison of the final state compared with the initial state confirms these performances were trending toward significance with a significant difference (P<1%) in favor of the product.
