Efficacy and safety of oral methotrexate vs oral tofacitinib in management of oral lichen planus A prospective randomised study
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Primary outcome include evaluation and assessment of therapeutic response of methotrexate and tofacitinib in oral lichen planus according to Thongprasom score.
研究概览
简要总结
Oral lichen planus (OLP) is a chronic inflammatory condition marked by erythema, erosions, and purplish plaques exhibiting a distinctive white lacy pattern called Wickham striae on the oral mucosa. Achieving an accurate diagnosis of oral lichen planus necessitates a comprehensive approach involving thorough history-taking, clinical examination, dermoscopy, mucoscopy and histopathological evaluation. While patients displaying the typical reticular form of OLP may have a clinically diagnostic presentation, it is prudent to perform an oral biopsy. Despite its prevalence, there is currently no universally recognized treatment that achieves complete remission of OLP symptoms. This randomized, prospective study aims to compare the efficacy and safety of oral methotrexate vs oral tofacitinib in the treatment of oral 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
- •Patients who are diagnosed case of oral lichen planus with or without skin lesions .
- •Both sexes.
- •Male and Female.
- •Age- More than 18 years and less than 60 years.
排除标准
- •Age less than 18 years or more than 60 years.
- •Pregnancy, those female patients who are planning for pregnancy in next one month and lactation.
- •Patients unwilling to give consent to be part of trial.
- •Patients with active or latent TB.
- •Patients with anemia, liver disease, kidney disease, GI disease ( diverticulitis, perforation, ulcers ), respiratory disease ( ILD, COPD, pulmonary edema )
- •Patients with malignancies or lymphoproliferative disorders.
- •Patients on potent immunosuppressants, biological DMARDS, H/O organ transplant.
- •Patients with deranged lipid profile.
- •H/O recent live vaccination.
- •Family history of melanoma/non melanoma skin disorders.
- •Alcohol intake, tobacco and smoking.
- •H/o any thromboembolic event, cardiovascular disease, stroke.
结局指标
主要结局
Primary outcome include evaluation and assessment of therapeutic response of methotrexate and tofacitinib in oral lichen planus according to Thongprasom score.
时间窗: Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks, Follow up period of 3 months
次要结局
- Secondary outcome include safety profile and tolerability of oral methotrexate and oral tofacitinib in the treatment of oral lichen planus.(Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks, follow up period of 3 months)
研究者
Navneet Singh
Shri Bhusaheb Hire Government Medical College