STUDY THE EFFICACY AND SIDE EFFECTS OF SUBCUTANEOUS V/S ORAL METHOTREXATE IN THE MANAGEMENT OF MODERATE TO SEVERE PSORIASIS AND PALMOPLANTAR PSORIASIS

Not Applicable

Completed

• Conditions: Health Condition 1: L409- Psoriasis, unspecified

• Registration Number: CTRI/2020/10/028555
• Lead Sponsor: DrPooja

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-08-07
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

a) diagnosed to be suffering from Moderate to Severe Psoriasis and palmoplantar psoriasis or palmoplantar psoriasis clinically in

DERMATOLOGY OPD of a tertiary care centre in Karad

b)Have completed 18 years of age.

c)Have not taken any treatment, two months prior to the inclusion in study.

Exclusion Criteria

1.Hemoglobin < 8 gm/dl ,Total leukocyte count < 3500/ mm3, Platelet count < 100,000/mm3

2.Elevation of hepatic enzymes (alanine aminotransferase [ALT], aspartate aminotransferase [AST]) to more than twice the upper limit of normal or any deranged liver function tests.

3.Hepatitis, active or recurrent, cirrhosis or excessive current alcohol intake.

4.Use of other hepatotoxic drugs by the patient

5.Positive hepatitis B, hepatitis C or HIV serology

6.Pulmonary or extra-pulmonary active tuberculosis

7.Deranged renal function test.

8.Pregnancy or lactation or if patient is planning to conceive during the treatment period.

9.Patient on other immunosuppressive drugs

10.Recent live vaccination

11.Unreliable patient

12.Patients unwilling for monthly follow-ups.

13.Patient with known hypersensitivity to drug.

14.Patient with unrealistic expectation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in primary efficacy variables: PASI in chronic plaque psoriasis, m-PASI in palmoplantar psoriasisTimepoint: 7th day, 30th day, 60th, 90th day

Secondary Outcome Measures

Name	Time	Method
Improvement in secondary efficacy variables like VAG,PGA and DLQI in chronic plaque psoriasis, VAG,PGA,PPQOL in palmoplantar psoriasisTimepoint: 7th day, 30th day, 60th, 90th day