Dose Ranging Study to Compare the Efficacy and Safety of Methotrexate in Plaque Type Psoriasis

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Postgraduate Institute of Medical Education and Research
• Treatments: Methotrexate

Criteria

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.