JPRN-jRCT2080223498已完成2 期
A PhaseII Study of JTE-052 Ointment in Pediatric Patients with Atopic Dermatitis
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 103
研究概览
简要总结
The efficacy and safety of JTE-052 ointment were confirmed in pediatric patients with atopic dermatitis. The results supported either dose of 0.25% or 0.5% as the clinically recommended dose of JTE-052 ointment.
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 with atopic dermatitis
- •Modified Eczema Area and Severity Index(mEASI) >=5
排除标准
- •Patients with active infection
- •Patients with history of tuberculosis
- •Patients with hepatitis B/C virus carriers or history of hepatitis B/C virus infection
- •Patients with history or presence of malignant tumor
- •Use of topical corticosteroids (strongest or very strong) within 28 days before baseline
- •Use of topical corticosteroids (strong, medium or weak) or tacrolimus hydrate ointment within 7 days before baseline
研究者
相似试验
已完成
2 期
Phase II Clinical Study of JTE-052 - Dose finding study in patients with atopic dermatitisAtopic dermatitisJPRN-jRCT2080222835Japan Tobacco Inc.327
已完成
3 期
Phase III Study of JTE-052 Ointment in Pediatric Patients with Atopic DermatitisAtopic dermatitisJPRN-jRCT2080224005Japan Tobacco Inc.137
已完成
3 期
Phase III Clinical Study of JTE-052 - Randomized Controlled and Long-term Extension Study in Patients with Atopic DermatitisAtopic dermatitisJPRN-jRCT2080223499Japan Tobacco Inc.158
已完成
2 期
Phase 2 Clinical Study of JTE-061 Cream - Efficacy and Safety Study in Pediatric Patients with Atopic DermatitisAtopic DermatitisJPRN-jRCT2031210257emoto Takanori121
已完成
3 期
Phase III Clinical Study of JTE-052 - 52-week Long-term Study in Patients with Atopic DermatitisAtopic dermatitisJPRN-jRCT2080223500Japan Tobacco Inc.352