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Comparative study of efficacy and adverse effect of treatment with methotrexate versus a combination of methotrexate plus acitretin in chronic plaque psoriasis.

Comparative study of efficacy and adverse effect profile of treatment with methotrexate (0.3 mg/kg/week) versus a combination of low dose of methotrexate (0.15 mg/kg/week) plus low dose of acitretin (0.3 mg/kg/day) in chronic plaque psoriasis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/05/052753
Enrollment
134
Registered
2023-05-17
Start date
Unknown
Completion date
Unknown
Last updated
2023-05-29

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

Conditions

Health Condition 1: L400- Psoriasis vulgaris

Interventions

Intervention1: Combination arm of low dose of methotrexate (0.15 mg/kg/week) plus low dose of acitretin (0.3 mg/kg/day): In chronic plaque psoriasis patients with af

Sponsors

Department of Dermatology and Venereology
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of age 18-65 years 2. Given their consent to participate in the study 3. BSA >10, PASI >10 4. Cumulative methotrexate dose 5. Not taking any systemic therapy for 1 month prior to enrolment 6. Not applying topical therapy for 2 weeks prior to enrolment

Exclusion criteria

Exclusion criteria: 1. Pregnancy or lactation 2. History of alcoholism 3. Taking hepatotoxic or nephrotoxic drugs 4. History of prior treatment with oral retinoids 5. Hemoglobin 6. TLC 7. Platelet count 8. Lymphocytes 9. Raised SGPT/OT >= twice the normal limit at baseline or >= thrice the normal limit at follow up 10. Raised total bilirubin > 1.2 or 30 % increase in baseline 11. Serum creatinine values of > 1.4 mg/dl at baseline or more than 30% increase in baseline at two consecutive visits. 12. Tuberculosis, any reliable sign of infection, signs and symptoms suggestive of immunosuppression, or any chronic disease 13. Peptic ulcers

Design outcomes

Primary

MeasureTime frame
Attainment of PASI-75Timepoint: Week 2, 4, 8, 12, 16—

Secondary

MeasureTime frame
Attainment of PASI-100Timepoint: Week 2, 4, 8, 12, 16—

Countries

India

Contacts

Public ContactDr Sagnik De

Institute of Medical Sciences, Banaras Hindu University

drsatyendraderma@gmail.com9198120582

Outcome results

None listed

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