Comparative study of topical methotrexate gel 1% and topical mometasone furoate ointment 0.1% in the treatment of stable plaque psoriasis.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- 1.Efficacy of topical methotrexate gel 1% and topical mometasone furoate ointment 0.1% in the treatment of psoriasis
研究概览
简要总结
The study will be carried out on patients with mild to moderate stable plaque psoriasis in the department of dermatology at Indira Gandhi Institute of Medical Sciences,Patna.The diagnosis of psoriasis will be made clinically by an expert dermatologist and histopathological examination will be done wherever needed and written and informed consent will be taken.Demographic data and relevant medical history will be obtained from all patients.Patients will be randomly allocated into two groups .Group A will receive topical Mometasone furoate ointment 0.1% twice daily for 8 weeks and Group B will receive topical Methotrexate gel 1%twice weekly for 8 weeks.Lesions will be scored at baseline and after 2,4,6 and 8 weeks of treatment for erythema,scale and induration and DLQI questionnaire will be used to assess the impact on the quality of life of patients at the beginning and end of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Not using topical psoriasis treatment for at least 2weeks before the start of study.
- •2.Patients having mild to moderate chronic plaque psoriasis.
排除标准
- •1.Use of Phototherapy,PUVA or systemic therapy for psoriasis within 8 weeks before the start of study.
- •2.Pregnant and lactating women and women of child bearing potential who are not practicing an acceptable method of birth control.
- •4.Patients of unstable,erythrodermic,pustular and guttate psoriasis.
结局指标
主要结局
1.Efficacy of topical methotrexate gel 1% and topical mometasone furoate ointment 0.1% in the treatment of psoriasis
时间窗: Lesions will be scored at baseline and after 2,4,6 and 8 weeks of treatment
次要结局
- to determine the safety profile,tolerability of topical MTX gel and Mometasone furoate ointment(At 2,4,6 and 8 weeks of treatment.)