Psoriasis
Conditions
Brief summary
In this study the investigators intend to compare the efficacy and safety of two fixed doses of once weekly oral methotrexate in a prospective randomized double blind manner in patients with severe plaque type psoriasis.
Interventions
DRUGMethotrexate
once weekly for a total duration of 12 weeks or earlier till patient achieves PASI 75
Sponsors
Post Graduate Institute of Medical Education and Research, Chandigarh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patients with plaque-type psoriasis having more than 10% body surface area involvement (severe psoriasis).20 * Patients of either sex with age between 18-65 years. * Females who were postmenopausal or tubectomised or have completed their family size and are willing to maintain contraception 1 month before, during and 1 month after completion/stopping of treatment and negative pregnancy test 2 weeks before starting of treatment and at day 2 or 3 of a normal menstrual cycle. * Males who were willing to maintain contraception during and 3 months after completion/stopping of treatment.
Exclusion criteria
* Pregnant or lactating women. * Any abnormalities in renal function, cardiovascular disease, respiratory disease or neuropsychiatric illness. * Significant abnormalities in liver function (serum bilirubin, AST, ALT, and ALP \>1.5 times the upper limit of normal), viral hepatitis or cirrhosis. * history of excessive alcohol consumption. * Severe anemia, leucopenia or thrombocytopenia. * Active infectious disease or immune system deficiency including AIDS. * history of intolerance/hypersensitivity to methotrexate. * history of phototherapy in past 6 months. * Patients who had received any systemic treatment for psoriasis in the past 4 weeks and topical treatment in the past 2 weeks. * Body mass index (BMI) \> 30 kg/m2.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in Psoriasis Area and Severity Index (PASI) score between two groups from baseline to 12 weeks | 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| time to achieve PASI 75 | 12 weeks or earlier |
| number of patients achieving PASI 90 and 100 | 12 weeks or earlier |
Countries
India
Outcome results
None listed