COMPARATIVE STUDY OF THERAPEUTIC EFFECTIVENESS OF ORAL TOFACITINIB VERSUS BETAMETHASONE ORAL-MINI PULSE THERAPY IN TREATMENT OF UNSTABLE VITILIGO PATIENT IN OPD
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
This study is a comparative clinical study to evaluate the therapeutic effectiveness and safety of oral tofacitinib versus oral betamethasone mini pulse therapy in patients with unstable vitiligo. Vitiligo is an acquired depigmentary disorder characterized by loss of functional melanocytes leading to depigmented patches on the skin. Unstable vitiligo is defined by appearance of new lesions or increase in size of existing lesions over the last three months. Eligible patients attending the dermatology outpatient department will be enrolled after obtaining written informed consent. Participants will be randomly allocated into two groups. One group will receive oral tofacitinib, and the other group will receive oral betamethasone mini pulse therapy for a period of three months. Patients will be assessed at baseline and at follow up visits every four weeks for extent of disease, disease activity, and repigmentation using standard clinical assessment tools. Safety will be evaluated by monitoring adverse events and laboratory parameters. The results of this study will help in determining a more effective and safer systemic treatment option for management of unstable vitiligo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients aged 18–50 years Clinical diagnosis of unstable vitiligo Previously untreated patient Consenting Patient.
排除标准
- •Patients with stable vitiligo History of severe infections or immunosuppression Pregnant or lactating women Known hypersensitivity to Tofacitinib or corticosteroids Patients with uncontrolled diabetes, hypertension, or other serious comorbidities Patients currently on systemic immunomodulatory therapy for other diseases.
研究者
SAMYAK JAIN
MGM MEDICAL COLLEGE, INDORE
