JPRN-jRCT2080225316已完成3 期
Phase III Clinical Study of JTE-052 Ointment - Long-Term Study of JTE-052 Ointment in Japanese infant Patients with Atopic Dermatitis
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 22
研究概览
简要总结
This study confirmed that twice-daily dermal application of JTE-052 ointment 0.25% or 0.5% for 52 weeks resulted in low systemic exposure to JTE-052 and was safe and well tolerated in Japanese infant patients with atopic dermatitis. Twice-daily application of JTE- 052 ointment 0.25% or 0.5% improved atopic dermatitis in infant patients and the efficacy in improving atopic dermatitis was maintained during long-term application of JTE-052 ointment.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 6month old 至 <= 24month old（—）
- 性别
- All
入选标准
- •Patients diagnosed with mild, moderate or severe atopic dermatitis
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
研究者
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