Status:
COMPLETED
Dose Ranging Study to Compare the Efficacy and Safety of Methotrexate in Plaque Type Psoriasis
Lead Sponsor:
Post Graduate Institute of Medical Education and Research, Chandigarh
Conditions:
Psoriasis
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 pl...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01187264
Start Date
August 1 2008
End Date
September 1 2009
Last Update
August 25 2010
Active Locations (1)
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1
Postgraduate Institute of Medical Education and Research
Chandigarh, U.T, India, 160012