薬理と治療

Abstract

Objectives　While rivastigmine-containing transdermal patches are effective for the treatment for Alzheimerʼs diseases, there have been known some cases who could not continue the treatment because of skin irritation at the local application site. HP-1040 has been developed as a generic of rivastigmine patch with the 3-times expanding area for topical application. HP-1040 is expected to reduce skin irritation at the local application site because a drug concentration per unit area of HP-1040 is 1/3 lower compared to the original drug. We conducted randomized, non-blinded clinical trial which aims to compare the skin irritation between HP-1040 and the original drug. Methods　We conducted an open-label, multiple-dose study for 40 healthy middle-aged and elderly volunteers that each one sheet of HP-1040 and the original drug is to be put on the fixed and separated part of the body and skin assessment was conducted everyday. Results　The skin irritation score of HP-1040, a primary endpoint, was significantly lower than that of the original drug. The incidence of erythema at the application site of HP-1040 was half that of the original drug, however similar incidences of pruritus were shown on the application sites of HP-1040 and the original drug. Conclusions　HP-1040 was considered to be a formulation with reduced skin irritation than the original drug（. jRCTs031190145）