Status:
UNKNOWN
Comparison of Oral Versus Subcutaneous Route of Methotrexate Administration in Moderate to Severe Psoriasis
Lead Sponsor:
Post Graduate Institute of Medical Education and Research, Chandigarh
Conditions:
Psoriasis Vulgaris
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study is a prospective, single blinded, randomized, pilot study to compare the effectiveness and safety profile of oral versus subcutaneous route of administration of methotrexate in management o...
Detailed Description
Introduction: Methotrexate is one of the oldest and most commonly used systemic drugs for the treatment of psoriasis.\[1\] Even with the advent of other treatment modalities like systemic retinoids a...
Eligibility Criteria
Inclusion
- Patients aged more than 18 years with clinical diagnosis of plaque psoriasis
- Patients with body surface area involvement \> 10 %, PASI \>10, DLQI \>10.
Exclusion
- Hemoglobin \< 8 gm/dl ,Total leukocyte count \< 3500/ mm3, Platelet count \< 100,000/mm3
- Elevation of hepatic enzymes (alanine aminotransferase \[ALT\], aspartate aminotransferase \[AST\], or γ glutamyl transferase \[GGT\]) to more than twice the upper limit of normal.
- Hepatitis, active or recurrent, cirrhosis or excessive current alcohol intake .
- Use of other hepatotoxic drugs by the patient
- Positive hepatitis B, hepatitis C or HIV serology
- Pulmonary or extra-pulmonary active tuberculosis
- Deranged renal function test.
- Pregnancy or lactation or if patient is planning to conceive during the treatment period.
- Patient on other immunosuppressive drugs
- Recent live vaccination
- Unreliable patient
- Patients unwilling for monthly follow-ups. -
Key Trial Info
Start Date :
April 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2019
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03408756
Start Date
April 1 2018
End Date
December 30 2019
Last Update
March 14 2018
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