Efficacy and Safety of FK506 (Tacrolimus) Ointment in Children with Atopic Dermatitis-Phase III Double-blinded Comparison with Vehicle Ointment-
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Accession number;03A0475553
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| Title;Efficacy and Safety of FK506 (Tacrolimus) Ointment in Children with Atopic Dermatitis-Phase III Double-blinded Comparison with Vehicle Ointment- |
| Author;
OTSUKI MAMITARO
(Dep. Medicine, Jichi Medicial School, JPN)
KAWASHIMA MAKOTO
(School of Medicine, Tokyo Women's Medical Univ., JPN)
SHIBATA YOSHISADA
(Nagasaki Univ., Grad. Sch.)
NAKAGAWA HIDEMI
(Dep. Medicine, Jichi Medicial School, JPN)
HARADA SHOTARO
(Nippon Telegraph and Telephone East Corp., Kanto Medical Center, JPN)
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Journal Title;Journal of Clinical Therapeutics & Medicines
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Journal Code:Y0906A
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ISSN:0910-8211
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VOL.19;NO.6;PAGE.569-595(2003)
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| Figure&Table&Reference;FIG.5, TBL.21, REF.14 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;To assess the efficacy and safety of FK506 ointment 0.03% and 0.1%, compared with vehicle ointment in pediatric patients with atopic dermatitis (AD), a multicenter, randomized, double-blind comparative study was conducted in patients aged 2-15 years with moderate to severe AD. The ointment was applied twice daily for 3 weeks. An area of ca. 100cm2 with moderate to severe lesion on trunk or extremities was specified for the primary efficacy assessment. The primary efficacy endpoint was the change in the sum of scores for skin signs compared to that at baseline. 1) A total of 221 patients were randomly assigned to FK506 ointment 0.03% or 0.1%, or vehicle ointment (75 to the vehicle group, 75 to the 0.03% group, and 71 to the 0.1% group). 213 patients (71 in the vehicle group, 72 in the 0.03% group, and 70 in the 0.1% group) were included in efficacy analysis, and 214 patients (71 in the vehicle group, 73 in the 0.03% group, and 70 in the 0.1% group) were included in safety analysis. 2) Regarding the primary endpoint, the percentage of patients with improvement rates assessed as "markedly improved" or better (change ratio.GEQ.67%) at the end of treatment was significantly higher in the FK506 ointment groups than in the vehicle ointment group, although no significant differences between the two FK506 ointment groups were observed (75.7% in the 0.1% group, 66.7% in the 0.03% group and 12.7% in the vehicle group). 3) As for improvement rates at each 1-, 2- and 3-week treatment period, the 0.03% and 0.1% groups tended to have higher improvement rates compared to the vehicle group. Although significantly better rates were obtained in the 0.03% and 0.1% groups than in the vehicle group at each period, there was no significant difference between the two FK506 ointment groups at each period. 4) The incidence of skin irritation in the FK506 ointment groups was significantly higher than in the vehicle group... (author abst.) |
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