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临床试验/CTRI/2024/11/076876
CTRI/2024/11/076876尚未招募不适用

Efficacy of oral tofacitinib in the treatment of nail lichen planus: a pilot clinical trial

All India Institute Of Medical Sciences1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年1月20日最近更新:

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

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Somesh Gupta

All India Institute Of Medical Sciences

研究点 (1)

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