Statistics
The sample size of this pilot study was arbitrarily defined as 60 participants, estimating a minimum of 15 patients per arm to identify differences in the primary outcomes between the proposed treatments. This was a prospective randomized controlled trial with active control that tested the hypothesis of superiority, with a bilateral type I error rate of 0.05. The primary analysis was based on a “per protocol” population including all participants that were followed up through the last visit. The distribution of results according to severity was summarized as a percentage for each treatment arm. The baseline characteristics of each treatment arm were summarized. Descriptive measures such as mean, standard deviation (SD), and quartiles for quantitative variables and frequencies for categorical variables are presented. To compare the groups in relation to the outcome, binary analysis was performed, and the proportion of outcomes in each treatment arm was compared using Fisher's exact test. In addition, the relative risk was calculated with a 95% confidence interval. The patients’ evolution on the two-point scale was obtained by comparing their scores recorded at the time of screening and their last score recorded. A ≥2 point difference between the scores was considered an improvement. The Wilcoxon test for paired samples was used to assess the differences between plasma cytokine profiles at baseline D1 and D2). Analyses were performed using R 4.1.1 software