Long-term Study of FK506 (Tacrolimus) Ointment in Children with Atopic Dermatitis
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Accession number;03A0475554
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| Title;Long-term Study of FK506 (Tacrolimus) Ointment in Children with Atopic Dermatitis |
| Author;
KAWASHIMA MAKOTO
(School of Medicine, Tokyo Women's Medical Univ., JPN)
OTSUKI MAMITARO
(Dep. Medicine, Jichi Medicial School, JPN)
SHIBATA YOSHISADA
(Nagasaki Univ., Grad. Sch.)
HARADA SHOTARO
(Nippon Telegraph and Telephone East Corp., Kanto Medical Center, JPN)
NAKAGAWA HIDEMI
(Dep. Medicine, Jichi Medicial School, 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.597-636(2003)
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| Figure&Table&Reference;FIG.15, TBL.22, REF.15 |
| Pub. Country;Japan |
| Language;Japanese |
| Abstract;A randomized long-term open-label study was conducted to investigate the safety and efficacy of FK506 (Tacrolimus) ointment in the treatment of atopic dermatitis (AD) in children. The amount simply applied per dose was up to 5g once or twice a day. 1) Of the 214 patients enrolled (104 in the 0.03% group and 110 in the 0.1% group), One patient complicated with Netherton syndrome in the 0.1% was excluded from safety and efficacy analyses. 2) Although skin irritation at the FK506 ointment application site were observed in 50% (52/104) of the patients in the 0.03% group and 62.4% (68/109) in the 0.1% group, there was no significant difference in percent incidence between the two groups. The great majority of skin irritation signs developed within 7 days, mostly mild to moderate, and decreased with the improvement of skin symptoms. Other adverse reactions at the FK506 ointment application site included skin infections such as folliculitis, impetigo contagiosa, Kaposi's varicelliform eruption and molluscum contagiosum, which were observed in 33.7% (35/104) of the patients in the 0.03% group and 22.0% (24/109) in the 0.1% group. The accompanying symptoms such as acne vulgaris and acne pustulosa were also observed in 5.8% (6/104) of the patients in the 0.03% group and 8.3% (9/109) in the 0.1% group. As for abnormal changes in laboratory test values, eosinophilia and leukocytosis were observed in one case each in a single patient of the 0.1% group. 3) Regarding blood level of FK506, even the highest level was as low as 1.50ng/mL for the 0.03% group and 5.23ng/mL for the 0.1% group. Only 2 patients in the 0.1% group had blood level of FK506 exceeding 3ng/mL (up to 5.23ng/mL and 3.48ng/mL); in these patients, the blood level decreased with the improvement of skin symptoms without any systemic adverse reactions.... (author abst.) |
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