Severe Plaque Type Psoriasis Clinical Trial
Official title:
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.
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.
| Status | Recruiting |
| Enrollment | 50 |
| Est. completion date | |
| Est. primary completion date | January 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| India | Narayana Med College and Hospital | Nellore | AP |
| Lead Sponsor | Collaborator |
|---|---|
| Narayana Medical College & Hospital |
India,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Improvement in health related quality of life | 12 weeks | No | |
| Secondary | comparison of improvement in health related quality of life between Group A and Group B | 12 weeks | No |