Comparison of dexamethasone oral mini pulse therapy versus oral tofacitinib therapy in the treatment of pediatric alopecia areata: a randomized control trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change from baseline in Severity of Alopecia Tool (SALT) score at week 24 in Group A (oral dexamethasone mini pulse) versus group B (oral tofacitinib)
研究概览
简要总结
Alopecia areata (AA) is an autoimmune disorder that presents as one or more patches of non-scarring loss of hair (alopecia), occurring most commonly over the scalp but can be severe enough to involve all body hair. The most accepted hypothesis in the pathogenesis of AA is of autoimmune etiology. Limited data available on efficacy and safety of oral mini pulse of corticosteroids in adults, but no randomized controlled trials have been conducted in the pediatric age group. Several case reports and case series have described successful use of tofacitinib in pediatric patients with alopecia areata without any serious adverse events. While therapeutic efficacy in the treatment of pediatric patients with severe AA in several case series, prospective and controlled trials are needed to assess the safety and efficacy of the use of oral tofacitinib in the long-term management of AA in the pediatric patient population. This study aims to compare the efficacy of oral dexamethasone mini pulse with oral tofacitinib as well as to compare the safety profile of the two drugs in pediatric alopecia areata.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 5.00 Year(s) 至 14.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients with moderate to severe alopecia areata with SALT score more than 25
- •Age between 5 to 14 years.
排除标准
- •Another type of alopecia or active inflammatory disease involving the scalp.
- •Oral or intralesional treatment that may impact alopecia areata within the last 4 weeks, and topical treatment within the last 2 weeks.
- •Patients with severe hepatic, renal or other systemic disorder, serious infections like HIV, Hepatitis B, Hepatitis C.
- •Presence of any contraindication for corticosteroids or tofacitinib.
结局指标
主要结局
Change from baseline in Severity of Alopecia Tool (SALT) score at week 24 in Group A (oral dexamethasone mini pulse) versus group B (oral tofacitinib)
时间窗: Week 24
次要结局
- Proportion of patients achieving 30% improvement in SALT score (SALT30 ) at week 24 in Group A (oral dexamethasone mini pulse) versus group B (oral tofacitinib)(Week 24)
- Proportion of patients achieving SALT50/75/90/100 in Group A (oral dexamethasone mini pulse) versus group B (oral tofacitinib)(Week 24)
- Percentage change from baseline in SALT score in Group A (oral dexamethasone mini pulse) versus group B (oral tofacitinib)(Week 24)
- Percentage change from baseline in cDLQI score in Group A (oral dexamethasone mini pulse) versus group B (oral tofacitinib)(Week 24)
- Incidence of adverse effects in Group A (oral dexamethasone mini pulse) versus group B (oral tofacitinib)(Week 4, 8, 12, 16, 20, 24)
研究者
Dr Rahul Mahajan
Post Graduate Institute of Medical Education and Research
