CTRI

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CTRI Number

CTRI/2025/09/095000 [Registered on: 17/09/2025] Trial Registered Prospectively

Last Modified On:

17/09/2025

Post Graduate Thesis

Yes

Type of Trial

Observational

Type of Study

Cohort Study

Study Design

Other

Public Title of Study

A study to compare the effectiveness of oral cyclosporine and oral methotrexate in treating moderate to severe plaque psoriasis

Scientific Title of Study

Comparative assessment of effectiveness between oral cyclosporine and oral methotrexate in patients with moderate to severe plaque psoriasis: a prospective, parallel-group observational study

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Devapandian M
Designation	Junior Resident
Affiliation	Government Medical College, Nagpur
Address	Department of Dermatology and Pharmacology, Government Medical College,Hanuman Nagar, Ajni Rd, Medical Chowk, Ajni, Nagpur Nagpur MAHARASHTRA 440003 India
Phone	9487424469
Fax
Email	dr.devapandian@gmail.com

Details of Contact Person
Scientific Query

Name	Avinash V Turankar
Designation	Professor and Head
Affiliation	Government Medical College, Nagpur
Address	Department of Pharmacology, Government Medical College, Hanuman Nagar, AjniRd, Medical Chowk, Ajni, Nagpur Nagpur MAHARASHTRA 440003 India Nagpur MAHARASHTRA 440003 India
Phone	9822472329
Fax
Email	aturankar@hotmail.com

Details of Contact Person
Public Query

Name	Dr Devapandian M
Designation	Junior Resident
Affiliation	Government Medical College, Nagpur
Address	Department of Pharmacology, Government Medical College,Hanuman Nagar, Ajni Rd, Medical Chowk, Ajni, Nagpur Nagpur MAHARASHTRA 440003 India
Phone	9487424469
Fax
Email	dr.devapandian@gmail.com

Source of Monetary or Material Support

Government Medical College, Hanuman Nagar, AjniRd, Medical Chowk, Ajni, Nagpur Nagpur MAHARASHTRA 440003 India

Primary Sponsor

Name	Department of Health Research under MoHFW
Address	Department of Health Research 2nd Floor, IRCS Building, 1, Red Cross Road,New Delhi - 110001
Type of Sponsor	Government funding agency

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Devapandian M	GovernmentMedicalCollege,Nagpur	Department ofDermatology, HanumanNagar, Ajni Rd, MedicalChowk, Ajni, Nagpur,Maharashtra 440003 Nagpur MAHARASHTRA Nagpur MAHARASHTRA	09487424469 dr.devapandian@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
IEC GMC Nagpur	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: L400\|\|Psoriasis vulgaris,

Intervention / Comparator Agent

Type	Name	Details
Intervention	Oral Cyclosporine	The study group includes Patients receiving Tab. Cyclosporine.The dose,schedule and dosing regimen would be chosen by the treating dermatologist.Total duration of the study will be 16 weeks.Four follow up visits at 4th, 8th, 12th and 16th weeks will be conducted
Intervention	oral Methotrexate	The study group includes Patients receiving Tab. Methotrexate.The dose,schedule and dosing regimen would be chosen by the treating dermatologist.Total duration of the study will be 16 weeks.Four follow up visits at 4th, 8th, 12th and 16th weeks will be conducted.

Inclusion Criteria

Age From	18.00 Year(s)
Age To	65.00 Year(s)
Gender	Both
Details	NOT APPLICABLE

ExclusionCriteria

Details

1. Patients with pustular, erythrodermic, and/or guttate forms of psoriasis (non-plaque forms of psoriasis).
2. Patient prescribed other systemic anti-psoriatic therapies (e.g., biologics, retinoids) in combination with methotrexate or cyclosporine.
3. Patients with a history of hypersensitivity or allergic reactions to cyclosporine or methotrexate.
4. Patients with a history of malignancy or current malignancy.
5. Patients with a history suggestive of pregnancy.
6. Patients with a history of significant liver or renal impairment.
7. Patients in view of treating dermatologists may not be the suitable candidate for methotrexate or cyclosporin therapy due to any other factor.

Method of Generating Random Sequence

Not Applicable

Method of Concealment

Not Applicable

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
The mean change in PASI (Psoriasis Area and severity index) score at week 16	1. Baseline (start of treatment) 2. Follow up (4th, 8th, 12th weeks after initiation) 3. End of treatment (12 weeks afterinitiation) Follow-up assessments at 4, 8, 12weeks and 16weeks post-treatment to evaluate effedtiveness by seeing imrpovement in Psoriasis Area and severity index score

Secondary Outcome

Outcome	TimePoints
Proportion of patients attaining PASI 75 (Psoriasis Area and Severity Index) at the end of 16 weeks	Psoriasis Area and severity index score at the end of treatment (after 16 weeks from initiation)
Proportion of patients achieving good adherence to cyclosporine and methotrexate, defined as an Simplified Medication Adherence Questionnaire(SMAQ) score 0, at the end of 16 weeks.	Simplified Medication Adherence Questionnaire score at the end of treatment (after 16 weeks from initiation)

Target Sample Size

Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

N/A

Date of First Enrollment (India)

28/09/2025

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="2"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

Title of Study

Comparative assessment of effectiveness between oral cyclosporine and oral methotrexate in patients with moderate to severe plaque psoriasis a prospective, parallel-group observational study.

Introduction

Plaque psoriasis is a chronic inflammatory dermatological disorder with significant physical and psychosocial impact. Methotrexate and cyclosporine are established systemic therapies for moderate to severe cases, but comparative data on their effectiveness and safety in Indian patients remain limited and inconsistent. This study aims to directly compare both agents regarding disease improvement and adherence over 16 weeks.

Objectives

Primary Objective
To assess and compare the change in Psoriasis Area and Severity Index PASI score from baseline to 16 weeks between oral cyclosporine and oral methotrexate.

Secondary Objective
To compare patient adherence rates at 16 weeks using the Simplified Medication Adherence Questionnaire SMAQ scale in both treatment groups.

Methodology

a Materials and Methods

Study design is Prospective, parallel-group, observational study.

Location is Dermatology OPD of tertiary care teaching hospital.

Duration is 24 months July 2025–July 2027 .

Enrolment Patients will be allocated to receive either oral cyclosporine or oral methotrexate, as per dermatologist discretion, with standard topical adjuncts emollients, corticosteroids . Four scheduled follow-up visits at 4, 8, 12, and 16 weeks .

b Inclusion Criteria

Age 18–65 years inclusive , any gender.

Moderate to severe plaque psoriasis PASI greater than or equal to10 , diagnosis by dermatologist.

New patients prescribed one of the study drugs.

less than or equal to16 weeks prior systemic therapy, documented PASI at defined intervals.

Adjunct topical therapy allowed.

Written informed consent.

c Exclusion Criteria

Non plaque psoriasis subtypes.

Use of other systemic anti psoriatic therapies or biologics in combination.

History of drug allergy methotrexate or cyclosporine , malignancy, pregnancy, significant liver or renal impairment.

Determined unsuitable by treating dermatologist.

d Endpoints

Primary Endpoint
Change in mean PASI score from baseline to 16 weeks.

Secondary Endpoints

Proportion of patients attaining PASI75 at 16 weeks.

Proportion of patients adherent to therapy SMAQ score equal to 0 at 16 weeks .

e Primary Outcome

Mean reduction in PASI score at week 16 between groups.

f Secondary Outcomes

Proportion with PASI75 response.

Proportion with good adherence to cyclosporine and methotrexate SMAQ score equal to 0 .

Study Procedure

Eligibility screening, signed informed consent.

Baseline clinical examination, history, PASI scoring.

Allocation to Group A cyclosporine or Group B methotrexate per standard prescribing.

Regular follow ups at 4, 8, 12, 16 weeks with repeat PASI scoring and adherence assessment.

Data recorded in case record forms.

Drug Availability

Both drugs oral cyclosporine and oral methotrexate are available at the study site and prescribed as per routine clinical practice. Folic acid supplementation provided with methotrexate.

Data Collection

Clinical data and adherence scores will be documented at each visit in standardized electronic and paper forms.

Statistical Analysis

Sample size 80 40 per group , with 10percentage dropout rate anticipated.

Unpaired t test for mean change in PASI.

ANCOVA to adjust for baseline PASI.

Logistic regression for prognostic factors related to treatment success/failure.

Repeated measures ANOVA for within group PASI changes.

Chi square for PASI75 and adherence rates.

Analysis performed via GraphPad Prism and SPSS v26 p less than 0.05 is significant.

Ethical Consideration

Study conducted under institutional ethics committee approval, following ICMR, Good Clinical Practice, Declaration of Helsinki. Written informed consent required privacy and confidentiality assured patients free to withdraw at any time.

Expected Impact

This study will provide robust comparative evidence on the efficacy, safety, and adherence of oral cyclosporine and methotrexate in moderate to severe plaque psoriasis among Indian patients, guiding future therapeutic decisions and standard of care protocols.