A Comparative study for the efficacy and side effects in subcutaneous and oral methotrexate in patients of chronic plaque psoriasis.

Phase 3

• Conditions: Health Condition 1: D50-D89- Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism

• Registration Number: CTRI/2020/07/026598
• Lead Sponsor: Ishan Agrawal

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Patients more than 18 years of age, with clinically diagnosed and biopsy proven plaque psoriasis, who have given their consent to be included in the study.

2. Patients with body surface area involvement > 10 %, Psoriasis Area and Severity Score >10, Dermatological Life Quality Index >10.

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], or γ glutamyltransferase [GGT]) to more than twice the upper limit of normal.[4]

3. Hepatitis, active or recurrent,

4. Cirrhosis or excessive current alcohol intake.

5. Use of other hepatotoxic drugs by the patient.

6. Positive Hepatitis B, Hepatitis C or HIV serology.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Psoriasis Area Severity Index, Physician Global Assessment, Medication Adherence Score, Dermatology Life Quality Index, Dermoscopy, Photographic AssessmentTimepoint: 0,4,8,12,16,24 weeks and 6 months

Secondary Outcome Measures

Name	Time	Method
Side effect profile, Patient complianceTimepoint: 0,4,8,12,16,24 weeks and 6 months.