An Open Label Prospective Clinical Study to evaluate the effects of N-163 strain of Aureobasidium Pullulans Produced β 1,3-16 Glucans in modulating the immunity in patients with Psoriasis

Study Design : An Open Label, Prospective, Clinical Study Treatment Arms : II Treatment Arms Treatment I : Standard Therapy + n-163 beta glucan Treatment II : n-163 beta glucan

Primary Outcome Measures - C Reactive Protein - Tumor Necrosis Factor - Interleuken 2 - Interleuken 6 - Interleuken 17 - Inteleuken 12 Secondary Outcome Measures - Improvement in patient symptoms - Physician’s Evaluation of Plaque Severity - PASI 75 - PASI 50 - 5 Point Reduction in DLQI - Skin Biopsy : H& E Staining & Immunohistochemistry for TNF alpha, IL6, IL17, VEGFR2, Prolactin receptor Background of the study Psoriasis is achronic, immune-mediated skin inflammatory condition in which the number andlocation of skin lesions and comorbidities such psoriatic arthritis haveprofound negative effects on the quality of life of the affected patients. Theachievement of psoriasis clearance or near clearance is a need for therapeuticsuccess, and this best correlates with an increase in quality of life Treatmentsinclude conventional topical medications, oral medications, biological, andoral small molecules. IL-6 has been linked to the etiology of psoriasis forover 25 years.

Purpose of the study N-163 betaglucan has potent anti-inflammatory activities which has been proven in animaland human clinical studies. In an animal study of obese diabetic mice model ofKK-Ay mice, N-163 beta glucan was able to regulate the levels of non-esterifiedfatty acids (NEFA) in 28 days. NEFA  isassociated with metabolic syndrome induced inflammation   andaltered NEFA  composition in immune cellmembranes has been shown to influence immune cell functions possiblycontributing to the positive correlations between these fatty acids and MSdisease outcome