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

A prospective randomised comparative study on the efficacy and safety profile of oral and subcutaneous methotrexate in patients of moderate to severe chronic plaque psoriasis

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/07/026598

Enrollment

100

Registered

2020-07-15

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Subcutaneous Methotrexate: Methotrexate given by subcutaneous route in weekly doses in patients of Chronic Plaque Psoriasis. Control Intervention1: Oral Methotrexate: Methotrexate given

Eligibility

Inclusion criteria

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

Exclusion criteria: 1. Hemoglobin 2. Elevation of hepatic enzymes (Alanine aminotransferase [ALT], Aspartate aminotransferase [AST], or Î³ 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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Side effect profile, Patient complianceTimepoint: 0,4,8,12,16,24 weeks and 6 months.	—

Countries

India

Contacts

Public ContactIshan Agrawal

IMS and SUM Hospital

ajayajenabbsr@gmail.com9437909933

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026