EFFICACY AND TOLERABILITY OF SUBCUTANEOUS V/S ORAL METHOTREXATE IN THE MANAGEMENT OF MODERATE TO SEVERE PSORIASIS AND PALMOPLANTAR PSORIASIS - A HOSPITAL BASED PROSPECTIVE RANDOMIZED CONTROLLED COMPARATIVE STUDY
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Improvement in primary efficacy variables: PASI in chronic plaque psoriasis, m-PASI in palmoplantar psoriasis
研究概览
简要总结
This will be a prospective investigator blind randomized controlled comparative study in patients of moderate to severe psoriasis and palmoplantar psoriasis attending Dermatology OPD of a tertiary care centre over a period of 1 year. Patient with moderate to severe psoriasis (PASI 10 and above),Palmoplantar psoriasis fulfilling the inclusion and exclusion criteria will be selected. Informed consent will be taken. Before treatment patients will be examined thoroughly using clinical and laboratory measures for any underlying disease.Use of concomitant topical or systemic treatment that could affect the outcome of the disease condition will not be permitted until the end of the study.After baseline evaluation of Psoriasis Area & Severity Index(PASI) DLQI (Dermatology life quality index), Physician Global Assessment (PGA), Visual Analogue Scale (VAS), Modified Psoriasis Area Severity Index(Modified PASI), Psoriasis severity scale (PSS), Palmoplantar quality of life instrument (PPQOL) and blood investigations by investigator, patients will then be allotted Group A and Group B via randomnisation. Thus each subgroup will have equal number of patients in each group.
Group A- The selected patients will be administered oral Methotrexate (0.3-0.5mg/kg bodyweight) per week
Group B- The selected patients will be administered Injectable Methotrexate (0.3-0.5mg/kg bodyweight) per week
Patients will be strictly instructed not to disclose the format, i.e. name of drugs or method of drug administration to the investigator by any form.Patient will be asked to follow up regularly for both the groups to assess safety and efficacy.At each visit patient will be assessed by investigator for efficacy by Psoriasis Area
& Severity Index(PASI), DLQI (dermatology life quality index), Physician Global Assessment (PGA), Visual Analogue Scale (VAS) in psoriasis group.Whereas palmoplantar group will be assessed for efficacy at each visit by Modified Psoriasis Area Severity Index(Modified PASI), Psoriasis severity scale (PSS), Palmoplantar quality of life instrument (PPQOL), Physician Global Assessment (PGA), Visual Analogue Scale (VAS).
To assess the safety profile of drugs laboratory investigations will be ordered as per the visit schedule and noted by investigator.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •a) diagnosed to be suffering from Moderate to Severe Psoriasis and palmoplantar psoriasis or palmoplantar psoriasis clinically in DERMATOLOGY OPD of a tertiary care centre in Karad b)Have completed 18 years of age.
- •c)Have not taken any treatment, two months prior to the inclusion in study.
排除标准
- •1.Hemoglobin < 8 gm/dl ,Total leukocyte count < 3500/ mm3, Platelet count < 100,000/mm3 2.Elevation of hepatic enzymes (alanine aminotransferase [ALT], aspartate aminotransferase [AST]) to more than twice the upper limit of normal or any deranged liver function tests.
- •3.Hepatitis, active or recurrent, cirrhosis or excessive current alcohol intake.
- •4.Use of other hepatotoxic drugs by the patient 5.Positive hepatitis B, hepatitis C or HIV serology 6.Pulmonary or extra-pulmonary active tuberculosis 7.Deranged renal function test.
- •8.Pregnancy or lactation or if patient is planning to conceive during the treatment period.
- •9.Patient on other immunosuppressive drugs 10.Recent live vaccination 11.Unreliable patient 12.Patients unwilling for monthly follow-ups.
- •13.Patient with known hypersensitivity to drug.
- •14.Patient with unrealistic expectation.
结局指标
主要结局
Improvement in primary efficacy variables: PASI in chronic plaque psoriasis, m-PASI in palmoplantar psoriasis
时间窗: 7th day, 30th day, 60th, 90th day
次要结局
- Improvement in secondary efficacy variables like VAG,PGA and DLQI in chronic plaque psoriasis, VAG,PGA,PPQOL in palmoplantar psoriasis(7th day, 30th day, 60th, 90th day)