Evaluation of a new topical cream to psoriasis treatment: randomized clinical trial

Abstract

The aim of this study is to develop a new topical cream for psoriasis and to test its results. Experimental clinical trial. Phase I: hypersensitivity test in 100 healthy volunteers. Phase II: 120 patients, prospective, analytical differential study in hospital. In phase I, 99% health persons did not show any reaction. In phase II, the 120 patients selected in two groups, group A-new cream and group B-corticosteroid, the paired samples calculated T-value in group A was: 19.144 for erythema, 6.725 in infiltrate, 12.475 in desquamation and in pruritus 10.863, PASI 14.662 and BSA 19.083 which are higher than 1.96 the result was 0.000 less than P 0.05 highly significant after treatment group B control group, showed the T values, erythema 7.590, infiltrate 10.573, desquamation 7.311, pruritus 3.615, PASI 2.631, BSA 4.411. The T-values which are higher than 1.96 were 0.000 less than P 0.05 highly significant after treatment. In the Pearson correlation for cases and controls, association values were observed for SBA 0.042 before treatment and 0.008, after treatment, in PASI 0.021, before treatment and 0.008 after treatment. The results examined by hypotheses and cross-tabulations are highly significant in groups A and B separately, and when group A is tested against group B by means of cross-tabulations, they show differences after treatment. In the logarithmic regression for the associated risk factors, the odds ratio values of BMI 1.113>OR 1 and urea 1.439>OR 1. The elevation of these two parameters may affect the exposed group. When comparing the group, A and group B, the symptoms of erythema, infiltrate, desquamation, pruritus, PASI index and SBA were found to decrease with the group A/new cream after treatment. Further studies in larger populations are suggested, the new cream has been shown to reduce the clinical symptoms of psoriasis.