title: High-concentration (20 mug/g) tacalcitol ointment therapy on refractory psoriasis vulgaris with low response to topical corticosteroids.
abstract: The efficacy and safety of the application of high-concentration (20 mug/g) tacalcitol ointment once daily for 12 weeks to psoriasis vulgaris lesions which showed low response to topical corticosteroids, were evaluated in a prospective, multicenter, open-label study. Eighty patients were enrolled in the safety analysis of the test drug, and 54 of the 80 patients in the efficacy analysis. The efficacy rate based on the number of cases graded as "moderate improvement" or better in the final global improvement rating of the 54 cases included in the efficacy analysis, was 88.9% (95% CI: 77.4-95.8%). Significant improvement in erythema, thickness, and scaling was observed from 2 weeks of treatment onward (p < 0.001). Five local adverse reactions (2 events of irritation, 2 events of itching, and 1 event of redness) were observed in 3 of the 80 patients included in the safety analysis. There were no significant changes in mean serum calcium values. Tacalcitol 20 mug/g ointment is concluded to be effective and safe for the treatment of refractory psoriasis vulgaris with low response to topical corticosteroids.
authors.affiliation: Department of Dermatology, Nagasaki University, School of Medicine, 1-7-1 Sakamoto, Japan. nkatayam@net.nagasaki-u.ac.jp
authors.forename: Ichiro
authors.initials: I
authors.lastname: Katayama
authors.forename: Akira
authors.initials: A
authors.lastname: Ohkawara
authors.forename: Muneo
authors.initials: M
authors.lastname: Ohkido
authors.forename: Shotaro
authors.initials: S
authors.lastname: Harada
authors.forename: Kunihiko
authors.initials: K
authors.lastname: Tamaki
authors.forename: Hidemi
authors.initials: H
authors.lastname: Nakagawa
authors.forename: Yoshiaki
authors.initials: Y
authors.lastname: Hori
authors.forename: Shigeo
authors.initials: S
authors.lastname: Nishiyama
mesh_terms: D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D000368:Aged; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use; D004100:Dihydroxycholecalciferols / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D005938:Glucocorticoids; D006801:Humans; D008297:Male; D008875:Middle Aged; D009824:Ointments; D011336:Probability; D011446:Prospective Studies; D011565:Psoriasis / Q000175:diagnosis / Q000188:drug therapy*; D012720:Severity of Illness Index; D018709:Statistics, Nonparametric; D017211:Treatment Failure; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D004100:Dihydroxycholecalciferols; D005938:Glucocorticoids; D009824:Ointments; C023850:1 alpha,24-dihydroxyvitamin D3