Clinical Management Of Psoriasis Using 0.25% Niosomal Methotrexate Gel: A Placebo Controlled Double Blind Study

Abstract

In the formulation of topical dosage forms, more attention has been devoted to new structures, which can ensure either adequate localization of drug within the skin to enhance the local effect or can increase the penetration through the stratum corneum. For these purposes vesicular systems such as niosomes and liposomes have been investigated by several groups. Drug delivery systems using colloidal particulate carriers such as liposomes or niosomes have distinct advantages over conventional dosage forms because the particles can act as drug containing reservoirs. Methotrexate (MTX) is used in psoriasis as a systemic therapy with lot of adverse effects. A novel sustained release niosomal 0.25% MTX using a polymer chitosan administered once daily for 12 weeks. It was compared with placebo gel and plain MTX 0.25% gel for the treatment of different types of psoriasis, especially palmoplantar psoriasis. 30 patients were enrolled for study. They were divided randomly in to three groups of 10 patients for each formulation. The patients with 25% or less than 25% psoriatic lesions were included for the study. The results are calculated using PASI scoring. Changes in the disease signs and symptoms indicated that both agents have anti psoriatic activity but not with placebo gel. However lesions treated with Niosomal chitosan-MTX formulation showed marked improvement in comparison to plain MTX and placebo gel inspite of twice a day application. Few patients experienced mild adverse events. No clinically significant changes in blood or other lab parameters were seen. The findings suggest that the 0.25% niosomal MTX in chitosan gel exhibited beneficial effect in psoriasis and did not exert any systemic toxicity.