Quality of Life of Patients With Psoriasis Treated With Methotrexate: Prospective, Randomized, Double-blind, Parallel Group Study.
Overview
Methotrexate (MTX) is considered the 'gold-standard' drug for the treatment of severe psoriasis. Health-related quality of life (HRQOL) is impaired in patients with psoriasis, more so if disease is severe.
Full Title of Study: “Improvement in the Quality of Life of Patients With Severe Plaque Psoriasis Treated With Systemic Methotrexate in Fixed Doses of 10mg or 25mg Orally Once Weekly: a Prospective, Randomized, Double-blind, Parallel Group Study.”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Study Primary Completion Date: January 2015
Interventions
- Drug: Methotrexate
Arms, Groups and Cohorts
- Experimental: Group A
- Methotrexate 10mg orally once weekly
- Active Comparator: Group B
- Methotrexate 25mg orally once weekly
Clinical Trial Outcome Measures
Primary Measures
- Improvement in health related quality of life
- Time Frame: 12 weeks
Secondary Measures
- comparison of improvement in health related quality of life between Group A and Group B
- Time Frame: 12 weeks
Participating in This Clinical Trial
Inclusion Criteria
Age range 18 to 65 years Both sexes Severe plaque-type psoriasis (BSA >10% or PASI >12) - Exclusion Criteria:
Pregnancy Lactation Malignancy or immunosuppression including HIV Liver disease Renal disease Non compliant Psychiatric illness Hypersensitivity to methotrexate in the past -
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 65 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Narayana Medical College & Hospital
- Provider of Information About this Clinical Study
- Principal Investigator: C V Krishna, C V Krishna – Narayana Medical College & Hospital
- Overall Official(s)
- C V Krishna, MD, Principal Investigator, Narayana Medical college and hospital
- Overall Contact(s)
- C V Krishna, MD, +91-0413-2655961, vijay_postgradmed@yahoo.com
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