Comparison of the clinical efficacy of subcutaneous versus oral administration of methotrexate in patients with psoriasis vulgaris
- Conditions
- psoriasis vulgarispsoriasis vulgaris,methotrexate,oral administration,subcutaneous injection
- Registration Number
- TCTR20190705002
- Lead Sponsor
- Faculty of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Enrolling by invitation
- Sex
- All
- Target Recruitment
- 80
Entry criteria require a clinical diagnosis of psoriasis vulgaris in patients who had
the Psoriasis Area Severity Index (PASI) score > 10 or body surface area (BSA) involvement >10% or who had PASI score <10 or BSA < 10% but did not respond to topical treatment and being at least 18 years of age
Exclusion criteria include pregnant or lactating women, known hypersensitivity to methotrexate, patients with malignancy or HIV-infection or hepatitis B or C infection, tuberculosis, and abnormal liver or kidney or hematologic function. All patients will have a 12-week washout of any systemic therapies including systemic corticosteroid, methotrexate, cyclosporine, acitretin, other immunosuppressive drugs, biologics and phototherapy for psoriasis prior to receiving the study drugs
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Clinical improvement at week 4, 8, 12, 16, 20, 24, amd 28 Psoriasis Area Severity Index (PASI) score
- Secondary Outcome Measures
Name Time Method patient's satisfaction at week 4, 8, 12, 16, 20, 24, amd 28 visual analog scale (VAS) method