| CTRI Number |
CTRI/2024/07/070540 [Registered on: 12/07/2024] Trial Registered Prospectively |
| Last Modified On: |
12/06/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing efficacy and safety Methotrexate VS oral Tofacitinib in management of palmoplantar psoriasis. |
|
Scientific Title of Study
|
A prospective, comparative, randomized study on efficacy, safety of oral methotrexate vs oral tofacitinib in management of palmoplantar psoriasis. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
KIRTI NITIN HAJARE |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
Shri bhuasaheb hire government medical college, dhule |
| Address |
SHRI BHAUSAHEB HIRE GOVERNMENT MEDICAL COLLEGE, SURAT BYPASS CHAKKARBARDI, DHULE. DEPARTMENT OF DERMATOLOGY, VENEREOLOGY, AND LEPROSY (OPD NO. 18), DHULE.
Dhule
MAHARASHTRA
424001
India |
| Phone |
8830831246 |
| Fax |
|
| Email |
hajare.kirti251994@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR. CHETAN RAJPUT |
| Designation |
PROFESSOR AND HEAD |
| Affiliation |
SHRI BHAUSAHEB HIRE GOVERNMENT MEDICAL COLLEGE,DHULE |
| Address |
SHRI BHAUSAHEB HIRE GOVERNMENT MEDICAL COLLEGE, SURAT BYPASS CHAKKARBARDI, DHULE. DEPARTMENT OF DERMATOLOGY, VENEREOLOGY AND LEPROSY, (OPD NO.18)
Dhule
MAHARASHTRA
424001
India |
| Phone |
8888487808 |
| Fax |
|
| Email |
drchetanrajput@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
KIRTI NITIN HAJARE |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
SHRI BHAUSAHEB HIRE GOVERNMENT MEDICAL COLLEGE,DHULE |
| Address |
SHRI BHAUSAHEB HIRE GOVERNMENT MEDICAL COLLEGE, SURAT BYPASS CHAKKARBARDI, DEPARTMENT OF DERMATOLOGY, VENEREOLOGY, LEPROLOGY ( OPD NO. 18) ,DHULE.
Dhule
MAHARASHTRA
424001
India |
| Phone |
8830831246 |
| Fax |
|
| Email |
hajare.kirti251994@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri bhausaheb hire, government medical college, surat bypass chakkarbardi, department of dermatology, venereology and leprosy, (opd no. 18), DHULE 424001 |
|
|
Primary Sponsor
|
| Name |
KIRTI NITIN HAJARE |
| Address |
SHRI BHAUSAHEB HIRE, GOVERNMENT MEDICAL COLLEGE, SURAT BYPASS CHAKKARBARDI, (OPD NO 18) ,DHULE, INDIA,424001 |
| Type of Sponsor |
Other [SELF FUNDED] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| KIRTI NITIN HAJARE |
Shri bhausaheb hire government medical college,dhule |
SHRI BHAUSAHEB HIRE GOVERNMENT MEDICAL COLLEGE, SURAT BYPASS CHAKKARBARDI,(OPD NO.18) , DEPARTMENT OF DERMATOLOGY, VENEREOLOGY,LEPROLOGY,DHULE.
Dhule
MAHARASHTRA |
08830831246
hajare.kirti251994@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| shri bhausaheb hire government medical college,dhule |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L408||Other psoriasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
oral methotrexate (according to body weight) |
Participants in this group will receive oral methotrexate, dosed according to standard clinical guidelines ( firstly test dose of 2.5mg is given, followed by complete blood count investigation, if results are within normal limits then weight-wise methotrexate dose is started) for palmoplantar psoriasis, adjusted for body weight and monitored for efficacy and safety for 12 weeks. |
| Comparator Agent |
Oral Tofacitinib 5mg daily twice a day. |
Participants in this group will receive oral tofacitinib, with dosage based on the most recent clinical recommendations for the management of palmoplantar psoriasis, with regular monitoring for response and adverse effects 12 weeks.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Adult aged more than 18 years and less than 60 years
2)Confirmed case of palmoplantar psoriasis by skin punch biopsy.
3)History of palmoplantar psoriasis for atleast 6 months.
4)Both male and female.
|
|
| ExclusionCriteria |
| Details |
1)Age less than 18years and more than 60 years.
2)Patient with nail psoriasis and psoriatic arthropathy.
3)Patient unwilling to give consent.
4)Patient with anemia and infections GI disease, respiratory diseases.
5)Patient planning to have children.
6)history of recent live vaccination
7)Patient with co-morbidities.
8)Alcohol consumption, tobacco and smoking.
9)Organ transplant.
10)Patient with thromboembolism, stroke, cardiovascular disease. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary endpoint will be the improvement in the Modified Palmoplantar Psoriasis Area and Severity Index (mPPPASI) score specifically for the palmoplantar regions, from baseline to the end of the treatment period. |
baseline,2weeks,4weeks,8weeks,12weeks, follow up period of 3 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary endpoints will include patient-reported outcomes on pain and discomfort, quality of life measures, and a comprehensive safety profile assessment including laboratory monitoring for potential drug-related adverse effects. |
baseline,2weeks,4weeks,8weeks,12weeks, follow up period of 3 months |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
Final Enrollment numbers achieved (Total)= "66"
Final Enrollment numbers achieved (India)="66" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
23/07/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
26/05/2026 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [hajare.kirti251994@gmail.com].
- For how long will this data be available start date provided 23-08-2025 and end date provided 23-08-2028?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
PALMOPLANTAR PSORIASIS IS A PERSISTENT INFLAMMATORY SKIN CONDITION CHARACTERISIED BY THE APPEARANCE OF THICKENED SCALY PLAQUES ON THE PALMS AND SOLES. THE CONDITION IS OFTEN RESISTANT TO CONVENTIONAL TOPICAL TREATMENTS SIGNIFICANTLLY IMPACTING THE PATIENT’S QUALITY OF LIFE AND LEADING TO BOTH PHYSICAL DISCOMFORT AND SOCIAL STIGMA. THE VARIABILITY IN TREATMENT RESPONSE NECESSITATIES ONGOING REASEARCH INTO MORE EFFECTIVE THERAPEUTIC STRATAGIES. THIS PROSPECTIVE, COMPARATIVE, RANDOMISED CLINICAL STUDY AIMS TO EVALUATE THE EFFICACY, SAFETY OF ORAL METHOTREXATE VS ORAL TOFACITINIB IN THE MANAGEMENT OF PALMOPLANTAR PSORIASIS. CONDUCTED IN THE DEPARTMENT OF DERMATOLOGY, VENEREOLOGY, LEPROLOGY AT A TERTIARY CARE CENTRE IN MAHARASHTRA, THE STUDY WILL ENLIST PATIENTS WHO MEET THE INCLUSION CRITERIA AND DIVIDE THEM INTO TWO TREATMENT GROUPS. GROUP A WILL RECEIVE ORAL METHOTREXATE, DOSED ACCORDING TO BODY WEIGHT FOR A PERIOD OF 12 WEEKS. GROUP B WILL BE GIVEN ORAL TOFACITINIB 5MG TWICE DAILY FOR THE SAME DURATION. THE PRIMARY OUTCOME WILL BE THE CHANGE IN MODIFIED PALMOPLANTAR PSORIASIS AREA AND SEVERITY SCORE ( MPPPASI ) FROM BASELINE TO THE END OF TREATMENT, WITH A FOLLOW UP PERIOD OF 3 MONTHS TO ASSESS THE DURABILITY OF CLINICAL RESPONSE AND TO MONITOR FOR POTENTIAL RECURRENCE OR SIDE EFFECTS. |