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
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
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