Safety and Pharmacokinetics of High-concentration TV-02 Ointment. Clinical Pharmacological Study.

• High-concentration TV-02 Ointment Clinical Study Group

Bibliographic Information

Other Title

• 高濃度ＴＶ‐０２軟膏の安全性と薬物動態　　臨床薬理試験
• — Clinical Pharmacological Study —
• —臨床薬理試験—

Abstract

A clinical pharmacological study was conducted to determine the safety, pharmacokinetics and efficacy of topical application of tacalcitol ointment (high-concentration TV-02 ointment containing 20μg/g of tacalcitol) in patients with psoriasis vulgaris. The ointment was applied once daily of doses of, 7g/day (140μg/day of tacalcitol) or 10g/day (200μg/day of tacalcitol) for a period of 28 days to 14 patients with psoriasis vulgaris. Two signs of local adverse reactions were noted in one patient (moderate reddening of the skin and feeling of irritation, but no signs of systemic adverse reactions were observed. Abnormal variations in four clinical laboratory values related to the study drug were observed in one patient. High-concentration TV-02 ointment was effective in 10 patients. Concerning pharmacokinetics, tacalcitol was detected in the serum 4 hours after application in 9 of the 14 patients, and the level had decreased to the detection limit or below the detection limit at 24 hours after application of the ointment. Thus, no accumulation was observed. Elevation of the serum calcium level was suspected in patient with declined renal function and in one patient who was concomitantly receiving a thiazide diuretic. In the other patients, some variations were noted in calcium-regulating hormones, but the calcium homeostasis appeared to be maintained. The results sugguest that if patients with declined renal functions and patients receiving concomitant administration of thiazide diuretics are excluded and if the daily dose of tacalcitol does not exceed 200μg, high-concentration TV-02 ointment is a safe drug for treating patients with psoriasis vulgaris.

Journal

• Nishi Nihon Hifuka

  Nishi Nihon Hifuka 64 (2), 237-252, 2002

  Western Division of Japanese Dermatological Association

Keywords

• Dermatology

Details

• CRID: 1390001204299451136
• NII Article ID: 10018925090
• NII Book ID: AN00183881
• DOI: 10.2336/nishinihonhifu.64.237
• ISSN: 18804047
• ISSN: 03869784
• ISSN: http://id.crossref.org/issn/03869784
• Web Site: https://search.jamas.or.jp/link/ui/2002193094
• Text Lang: ja
• Data Source:
  • JaLC
  • Crossref
  • CiNii Articles
• Abstract License Flag: Disallowed