Well-Controlled Comparative Study and Open Clinical Study of 0.05% Hydrocortisone-17-Butyrate Ointment (TS-1020)/TS-1020 Clinical Study Group

TS-1020 (TS) is a proprietary steroidal ointment which contains 0.05% hydrocortisone-17-butyrate. Locoid® Ointment (LO), which contains 0.1% of the topical steroid, has been generally used since 1975 as an ethical steroidal ointment. The vehicles of the two ointments are the same. In order to elucidate the clinical efficacy and safety of TS, well-controlled comparative study was perfromed in comparison with LO in 85 patients with moist type of eczema for 1 week application. The results showed that the efficacy rate of TS was 78.1%, whereas that of LO was 79.5%. The difference between TS and LO was not statistically significant. Then open clinical study of TS was done in 218 cases with moist type of eczema, lichenificated type of eczema, prurigo and hand eczema. The efficacy rates were 83. 3% (67/126 cases) in moist type of eczema, 79.6% (31/54 cases) in lichenificated type of eczema and 69.0% (16/29 cases) in chronic prurigo and hand eczema. Any side effect was noticed in the open clinical study. Therefore we concluded that TS is an excellent proprietary steroidal ointment with efficacy and safety.