PSORIATICUM: Topical Hypericum Perforatum for Moderate Plaque Psoriasis: Study Protocol for a Randomized Controlled Trial

Abstract

Introduction: Psoriasis is an autoimmune chronic inflammatory disorder in which an increased amount of Tumor Necrosis Factor Alpha (TNF-α) leads to the formation of psoriatic plaques. Hypericum perforatum (HP) is a flowering plant used as an herbal medication due to its antimicrobial, wound-healing, and anti-inflammatory properties. Pilot studies have reported its ability to decrease the levels of TNF-α and severity of psoriatic plaques in moderate forms of psoriasis with fewer side effects and lower costs compared to standard treatment. More extensive studies are needed to confirm this. Objectives: To assess the effectiveness of topical HP in decreasing the mean total PASI score at the end of 12 weeks in patients with moderate plaque psoriasis. Methods: PSORIATICUM is a phase II, single-center, two-arm parallel, double-blinded randomized clinical trial that has the purpose of evaluating the efficacy of HP versus a control vehicle based on the decrease of the PASI score. The primary outcome is the total PASI score in the treatment group, compared to the control group at the end of the 12 weeks of testing. Normality will be evaluated using Kolmogorv-Smirnov, having the statistical significance of the findings tested using a two-tail Student’s T test for independent means or Mann-Whitney-Wilcoxon test. The secondary outcomes include the mean PASI change at weeks 4 and 8. Discussion: PSORIATICUM will provide information about the usefulness of Hypericum perforatum to treat psoriasis, allowing for future trials to study a safe and accessible alternative treatment for the condition.