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

NCT ID: NCT02248792

Last Updated: 2014-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Severe Plaque Type Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group A

Methotrexate 10mg orally once weekly

Group Type EXPERIMENTAL

Methotrexate

Intervention Type DRUG

Group B

Methotrexate 25mg orally once weekly

Group Type ACTIVE_COMPARATOR

Methotrexate

Intervention Type DRUG

Interventions

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Methotrexate

Intervention Type DRUG

Eligibility Criteria

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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

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Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Narayana Medical College & Hospital

OTHER

Sponsor Role lead

Responsible Party

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C V Krishna

C V Krishna

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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C V Krishna, MD

Role: PRINCIPAL_INVESTIGATOR

Narayana Medical college and hospital

Locations

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Narayana Med College and Hospital

Nellore, Andhra Pradesh, India

Site Status RECRUITING

Countries

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India

Central Contacts

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C V Krishna, MD

Role: CONTACT

+91-0413-2655961

Facility Contacts

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Avisa Rao, MD

Role: primary

Other Identifiers

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NMCHDer

Identifier Type: -

Identifier Source: org_study_id

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