A double-blind randomized controlled trial evaluating the effectiveness and safety of oral acitretin versus oral acitretin plus ustekinumab in non-syndromic congenital ichthyosis.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
研究概览
简要总结
This study will compare two treatments for children with non syndromic congenital ichthyosis. One group will receive oral acitretin which is the standard treatment. The other group will receive oral acitretin plus ustekinumab injection. The aim is to find out whether adding ustekinumab gives better improvement in skin scaling and dryness. The study will run for 24 weeks. Children will be checked at regular visits and blood tests will be done to monitor safety and to study changes in inflammation markers. Participation is voluntary and all study related tests and medicines will be provided free of cost. The information from this study may help improve treatment options for children with ichthyosis in the future.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged more than 6 years with genetically or clinically confirmed non syndromic congenital ichthyosis or netherton syndrome will be included.
排除标准
- •will include syndromic ichthyosis, common ichthyosis (XLRI/ichthyosis vulgaris), recent use of systemic retinoids (within 8 weeks) or biologics (within 12 weeks), active infection, significant hepatic/renal dysfunction, uncontrolled hyperlipidemia, pregnancy/lactation, or contraindications to study drugs.
研究者
Dr Rahul Mahajan
Post Graduate Institute of Medical Education and Research