Quality of Life of Patients With Psoriasis Treated With Methotrexate: Prospective, Randomized, Double-blind, Parallel Group Study.

Narayana Medical College & Hospital

Status and phase: Unknown; Phase 4

Conditions: Severe Plaque Type Psoriasis

Treatments: Drug: Methotrexate

Study type: Interventional

Funder types: Other

Identifiers

NCT02248792

NMCHDer

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups

Group A

Experimental group

Description:

Methotrexate 10mg orally once weekly

Treatment:

Drug: Methotrexate

Group B

Active Comparator group

Description:

Methotrexate 25mg orally once weekly

Treatment:

Drug: Methotrexate