Efficacy of oral tofacitinib in the treatment of nail lichen planus: a pilot clinical trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Proportion of patients with clinical improvement of nail lichen planus after treatment
研究概览
简要总结
Nail lichen planus is a chronic inflammatory disease of unknown etiology, recognized as potentially critical nail disease due to irreversible scarring. It significantly affects patient’s quality of life due to pain and cosmetic disfigurement. Intralesional and intramuscular triamcinolone acetonide injection are considered first line therapies in moderate to severe cases whereas, oral retinoids and immunosuppressive agents are used as second line choices. However, these treatment modalities are associated with high rates of therapeutic failures and relapses, and not suitable for all patients. Current treatment options are limited and depend on the progression of disease. Janus kinase inhibitors, which target inflammatory skin diseases, can suppress both type 1 and type 2 cytokines, reducing the immune response and inflammation. Recent studies have shown benefits of oral JAK inhibitors in treating cutaneous lichen planus and lichen planopilaris. For nail lichen planus, there are few case reports available with beneficial effect. Therefore, our study aims to find out the effectiveness of oral tofacitinib in the treatment of nail lichen planus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Adult patients with nail lichen planus involving more than 3 nails with or without skin, hair and mucosa involvement.
排除标准
- •Anonychia of all 20 nails
- •Pregnant and lactating females
- •Patients with known contra-indications to oral tofacitinib
- •Patients with known cardiovascular disease or venous thromboembolism
- •Patients on topical treatment for last 2 weeks, systemic treatment for last 4 weeks 6.
结局指标
主要结局
Proportion of patients with clinical improvement of nail lichen planus after treatment
时间窗: 3 months and 6 months
次要结局
- 1 Change in mean NALSI after treatment(2. Change in mean DLQI after treatment)
研究者
Dr Somesh Gupta
All India Institute Of Medical Sciences
