To compare the safety and efficacy of oral and subcutaneous routes of administration of methotrexate in patients with severe psoriasis
Design
Total 60 patients will be randomized by lottery method into two equal groups with 30 patients in each group (sample size calculated by WHO sample size calculator)
Settings and conduct
National University of Medica Sciences in collaboration wit dermatology department of PEMH
Participants/Inclusion and exclusion criteria
inclusion criteria
1. Both gender, aged between 18 and 65 years
2. Severe psoriasis PGA score of 4
exclusion criteria
1. Pregnant or lactating women
2. Any respiratory, cardiac, GI, hepatic, or renal illness
3. Patients on biologics
Intervention groups
intervention group 1 :will receive oral Methotrexate (10 mg up to 25 mg) weekly.
intervention group 2 :will receive subcutaneous Methotrexate (10 mg up to 25 mg) weekly
Main outcome variables
PGA score
Adverse effects including number of episodes of vomiting and diarrhea
laboratory investigation for Hb level, serum ALT, serum AST, urea and creatinine levels.
General information
Reason for update
Acronym
none
IRCT registration information
IRCT registration number:IRCT20231010059674N1
Registration date:2024-12-12, 1403/09/22
Registration timing:registered_while_recruiting
Last update:2024-12-12, 1403/09/22
Update count:0
Registration date
2024-12-12, 1403/09/22
Registrant information
Name
Mehwish Amin
Name of organization / entity
National University of Medical Sciences, Pakistan
Country
Pakistan
Phone
+92 51 5488638
Email address
mehwishlaeeq8@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-01, 1403/02/12
Expected recruitment end date
2025-05-01, 1404/02/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative analysis of efficacy and safety of oral versus subcutaneous methotrexate in severe psoriasis in tertiary care hospital
Public title
Comparative analysis of efficacy and safety of oral versus subcutaneous methotrexate in severe psoriasis in tertiary care hospital
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients having severe psoriasis with PGA score 4 will be included in the study.
Patients on biologics for last 1 year
Exclusion criteria:
Pregnant or lactating women
Patients with any major respiratory, cardiac, GI, hepatic, or renal illness
Patients on biologics within last 1 year
Unwilling for monthly follow-up.
Age
From 18 years old to 65 years old
Gender
Both
Phase
4
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Coding will be done by the dermatologist.Patients will be randomised into two groups by lottery method.The code will be chosen by the patient.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this single blind study the researcher (outcome assessor )will be blinded. The treating dermatologist and the patients will be aware of the treatment provided with the label of " intention to treat single blind study"
Placebo
Not used
Assignment
Parallel
Other design features
patients will be followed for 12 weeks with monthly followup
Secondary Ids
1
Registry name
PEMH rawalpindi
Secondary trial Id
19/2024
Registration date
2024-03-15, 1402/12/25
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee Pak- emirates military hospital Rawalpindi
Control group:oral route is considered gold standard treatment in severe psoriasis so it will be considered as control group. Patients will receive 10-25 mg /week oral Methotrexate for 3 months with weekly followup.Monthly followup will be done for next 3 months to check for relapse.
Category
Treatment - Drugs
2
Description
Intervention group: Patients in this group will receive methotrexate in a dose of 10-25 mg weekly by subcutaneous route and will be followed up weekly for 3 months. Afterwards they will be followed for relapse by monthly visits for next 3 months.