跳至主要内容
临床试验/NCT00933023
NCT00933023撤回4 期

A Randomised Controlled Trial of Mild Versus Potent Topical Corticosteroids as Primary Treatment for Non-retractile Foreskin in Children.

Chelsea and Westminster NHS Foundation Trust1 个研究点 分布在 1 个国家开始时间: 2009年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
撤回
发起方
试验地点
1
主要终点
Achievement of fully retractile foreskin with full exposure of glans at the end of therapy

研究概览

简要总结

Topical steroids are used as treatment for non-retractile foreskin in children for decades, but, there are disagreement among physicians about the optimum potency of the agent used. This study is designed to determine any difference in the beneficial effects of mild versus potent topical corticosteroids in treatment of non-retractile foreskin in children.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
2 Years 至 16 Years(Child)
性别
Male
接受健康志愿者

入选标准

  • Children 2-16 with non-retractile foreskin

排除标准

  • Balanitis xerotica obliterans, balanitis, <2yrs

研究组 & 干预措施

Mild steroid

Experimental

1%hydrocortisone for 8 weeks

干预措施: hydrocortisone (Drug)

Potent Steroid

Experimental

干预措施: Betamethasone (Drug)

结局指标

主要结局

Achievement of fully retractile foreskin with full exposure of glans at the end of therapy

时间窗: 16 weeks

次要结局

  • Complications of topical corticosteroids(16 weeks)

研究者

发起方
Chelsea and Westminster NHS Foundation Trust
申办方类型
Other
责任方
Principal Investigator
主要研究者

Anindya Niyogi

Clinical Research Fellow

Chelsea and Westminster NHS Foundation Trust

研究点 (1)

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