跳至主要内容
临床试验/JPRN-jRCT2080224005
JPRN-jRCT2080224005已完成3 期

Phase III Clinical Study of JTE-052 Ointment - Randomized Controlled and Long-Term Extension Study of JTE-052 Ointment in Japanese Pediatric Patients with Atopic Dermatitis

Japan Tobacco Inc.0 个研究点目标入组 137 人开始时间: 2018年8月14日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
137

研究概览

简要总结

Following dermal application of JTE-052 ointment 0.25% twice daily for 4 weeks in pediatric patients with AD, the percent improvement in mEASI score at EOT was significantly greater in the 0.25% group than in the placebo group, demonstrating the superiority of the 0.25% group over the placebo group. Twice-daily application of JTE-052 ointment 0.25% or 0.5% for up to 56 weeks was safe and well tolerated in pediatric patients with AD. The improvements in AD were maintained during the treatment period.

研究设计

研究类型
Interventional

入排标准

年龄范围
>= 2age old 至 <= 15age old(—)
性别
All

入选标准

  • Patients diagnosed with mild, moderate or severe AD
  • Modified Eczema Area and Severity Index(mEASI) >=5

排除标准

  • Active infection at the prospective application site
  • History of tuberculosis
  • Hepatitis B/C virus carriers or history of hepatitis B/C virus infection
  • History or presence of malignant tumor
  • Use of topical corticosteroids (classified as strongest or very strong drugs) within 28 days before baseline
  • Use of topical corticosteroids (classified as strong, medium or weak drugs) or tacrolimus hydrate ointment within 7 days before baseline

研究者

相似试验