Comparison of Efficacy of Oral Methotrexate and Acitretin for Generalized Lichen Planus
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Efficacy of oral methotrexate vs. oral acitretin in the treatment of generalized lichen planus
研究概览
简要总结
Lichen planus is a chronic inflammatory skin condition with unknown etiology. It requires a long term treatment. Evaulating the most efficacious, safe and affordable treatment option is the need of the hour. This study is going to compare the efficacy of two familiar drugs (acitretin and methotrexate) in the treatment of generalized lichen planus as to find out the relatively more effective and safer treatment.
详细描述
Lichen planus (LP) is a chronic mucocutaneous condition of an unknown cause. It presents clinically as purple, itchy papules and plaques on the lower back, body folds, oral mucosa, and on the scalp(1). It is recurrent condition with a prolonged course and requires an effective, safer and relatively cheaper treatment option (2).
Objective
"To compare the efficacy of oral methotrexate vs. oral acitretin in the treatment of generalized lichen planus".
Material & Methods: This randomized comarative study will be carried out in Outpatient Dermatology Department, Sheikh Zayed Hospital Rahim Yar Khan, Pakistan. Approval of the study has been taken from ethical review committee of the hospital.Data will be collected on prescribed form. Patient will be selected on basis of inclusion & exclusion criteria. Informed consent will be taken from selected patients before data collection. Study will include 124 patients which will be divided into 2 groups A & B, 62 in each group. Group A will receive oral methotrexate 10mg once weekly for 12 weeks. Group B will receive oral acitretin 50mg daily for 12 weeks. Folic acid will be given to all patients in group A at a dose of five milligram per day. Patient will be followed at 4 weekly interval and final efficacy will be determined at 12th week.Data will be analyzed by SPSS v25.0.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-60 years
- •Gender: both male and female
- •Type of Lichen planus: generalized lichen planus
- •Patients not taking prior treatment in last 1 month
排除标准
- •Pregnancy and lactating females
- •Bleeding disorders
- •Abnormal liver function tests
- •Platelet count less than 100000
- •Hypersensitivity to Methotrexate or Acitretin
- •Unrealistic expectations
研究组 & 干预措施
Oral methotrexate group (Group A)
Patients with generalized lichen planus will be given 10 mg per week
干预措施: Methotrexate (drug) (Drug)
Oral Acitretin group (Group B)
Patients with generalized lichen planus will be given oral acitretin 50 mg once daily
干预措施: Acitretin (Drug)
结局指标
主要结局
Efficacy of oral methotrexate vs. oral acitretin in the treatment of generalized lichen planus
时间窗: Clinical assessment for efficacy will be done 4 weekly for 12 weeks.
Efficacy will be assesssed clinically at each follow up visit. Final efficacy of each treatment will be determined at last follow up visit( i.e. at 12 th week after start of treatment).The final efficacy will be divided into following groups on the basis of clinical resolution of disease: 1. Remission: It is defined as complete resolution of all lesions leaving behind normal skin or post inflammatory pigmentation. 2. Improvement: It is defined as a more than 50% decrease of the disease, as clinically measured by the surface area from the baseline. 3. No improvement: It is defined as less than a 50% improvement in the disease, as measured clinically by the surface area from the baseline.
次要结局
未报告次要终点
研究者
Mohibullah Zahidi
Post Graduate Resident in Dermatology
Sheikh Zayed Medical College