Treatment of Phimosis With Topical Steroid Cream -Double-blind, Randomized, Placebo-controlled Study in 98 Boys
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Retractability of foreskin
研究概览
简要总结
During last years topical steroid creams have been suggested to be effective treatment for non-retractable foreskin instead of circumcision.
Aim of this study is to investigate the efficacy, safety and persistence of treatment results of a medium potent steroid cream in a double-blind, randomized, placebo-controlled study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •non-retractable foreskin requiring treatment
排除标准
- •age under six years old, previous operation or steroid treatment for phimosis
研究组 & 干预措施
mometasone furoate cream
The study patient consecutive patients who were referred to outpatient clinic of Pediatric surgery for surgical treatment of non-retractable foreskin. The study patients were randomized to have either mometasone cream or placebo
干预措施: Mometasone furoate cream (Drug)
mometasone furoate cream
The study patient consecutive patients who were referred to outpatient clinic of Pediatric surgery for surgical treatment of non-retractable foreskin. The study patients were randomized to have either mometasone cream or placebo
干预措施: moisturizing cream (Drug)
moisturizer
干预措施: Mometasone furoate cream (Drug)
moisturizer
干预措施: moisturizing cream (Drug)
结局指标
主要结局
Retractability of foreskin
时间窗: 4-16 weeks
次要结局
未报告次要终点