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CTRI Number  CTRI/2025/09/094044 [Registered on: 01/09/2025] Trial Registered Prospectively
Last Modified On: 01/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of oral Methotrexate versus oral Tofacitinib in palmoplantar psoriasis 
Scientific Title of Study   Comparison of efficacy and safety of oral Methotrexate versus oral Tofacitinib in palmoplantar psoriasis an open label one year randomized control trial in a tertiary care hospital 
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 Gantvya Krishna 
Designation  Junior Resident 
Affiliation  Jawaharlal Nehru Medical College, Belagavi 
Address  Department of Dermatology, Venereology and Leprosy, Jawaharlal Nehru Medical College, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  6394069712  
Fax    
Email  krishgantvya95@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bhavana R Doshi 
Designation  MBBS, MD, Head of Department 
Affiliation  Jawaharlal Nehru Medical College, Belagavi 
Address  Department of Dermatology, Venereology and Leprosy, Jawaharlal Nehru Medical College, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9422306523  
Fax    
Email  bhavs1982@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Gantvya Krishna 
Designation  Junior Resident 
Affiliation  Jawaharlal Nehru Medical College, Belagavi 
Address  Department of Dermatology, Venereology and Leprosy, Jawaharlal Nehru Medical College, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  6394069712  
Fax    
Email  krishgantvya95@gmail.com  
 
Source of Monetary or Material Support  
Department of Dermatology, Venereology and Leprosy, Jawaharlal Nehru Medical College, Belagavi, Karnataka, 590010 
 
Primary Sponsor  
Name  Dr Gantvya Krishna 
Address  Department of Dermatology, Venereology and Leprosy, Jawaharlal Nehru Medical College, Belagavi, Karnataka- 590010 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
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 Gantvya Krishna  KLEs Dr Prabhakar Kore Hospital  OPD 23, 1st floor, Department of Dermatology, Venereology and Leprosy, Jawaharlal Nehru Medical College, Belagavi
Belgaum
KARNATAKA 
6394069712

krishgantvya95@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L408||Other psoriasis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Oral Methotrexate (GROUP A)  Patients of GROUP A will be asked to take Oral Methotrexate (0.3 mg/kg/week not exceeding 25 mg/week) once a week for 12 weeks or until achieving atleast 75% improvement in modified palmoplanter psoriasis area and severity index (m-PPPASI) from the baseline whichever, will be earliest. 
Intervention  Oral tablet  Oral tablet will be given in Group A Oral Methotrexate (0.3 mg/kg/week not exceeding 25 mg/week) once a week and Group B will be given Oral Tofacitinib (5 mg twice a day) for a period of 12 weeks or until achieving atleast 75% improvement in modified palmoplanter psoriasis area and severity index (m-PPPASI) from the baseline whichever, will be earliest. 
Comparator Agent  Oral Tofacitinib (GROUP B)  Patients of GROUP B will be asked to take Oral Tofacitinib (5 mg twice a day) for 12 weeks or until achieving atleast 75% improvement in modified palmoplanter psoriasis area and severity index (m-PPPASI) from the baseline whichever, will be earliest. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patient with Palmoplantar Psoriasis confirmed by clinical correlation, dermoscopy or biopsy proven in doubtful cases.
2. Patient’s of either sex of age group 18-65 years.
3. Patients not on any other systemic medication for the same for atleast 2 months or topical treatment for the same for past 1 month.
 
 
ExclusionCriteria 
Details  1. Patient having any co-morbidity such as metabolic syndrome, hypertension, diabetes mellitus, cardiovascular disease, depression, and autoimmune disease.
2. Pregnant or breast feeding women.
3. History of TB or any contact with patient of TB.
4. History of active infection like chronic liver disease, cirrhosis, HIV/AIDS, renal dysfunction or blood disorders.
5. Previous hypersensitivity recorded to Tofacitinib/methotrexate.
6. Any other dermatitis on palm and sole.
7. Patients on immunosuppressive therapy like azathioprine, cyclosporine, mycophenolate mofetil, etc for any other medical condition.
8. Patient on concomitant medications such as ketoconazole, fluconazole, rifampicin. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the efficacy of oral tofacitinib versus oral methotrexate in case of palmoplantar psoriasis.  one year 
 
Secondary Outcome  
Outcome  TimePoints 
To determine the safety of oral tofacitinib versus oral methotrexate in case of palmoplantar psoriasis.  one year 
 
Target Sample Size   Total Sample Size="46"
Sample Size from India="46" 
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   Phase 3 
Date of First Enrollment (India)   01/10/2025 
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="1"
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  
1. All patients with clinically diagnosed cases of palmoplanter psoriasis attending KLES Dr. Prabhakar Hospital and Medical Research Centre, Belagavi will be recruited.
2. Informed consent will be taken from all the patients included in the study.
3. All patients in study will undergo a detailed history taking, general physical, systemic and dermatological examination.
4. Data will be collected by a single examiner and recorded in case record proforma.
5. Patients will be explained about the treatment offered in terms of expected results, duration of treatment, follow-ups, side effects to be reported, and prognosis of treatment.
6. Digital photographs of both palm and sole will be taken using identical camera settings, patients positioning and room lighting at baseline and at every sitting.
7. The process will be repeated every 4 weeks for a period of 12 weeks or >75% improvement in m-PPPASI score of the patient.
8. The list of side effects reported during the course of treatment will be treated accordingly. 
9. After 12 weeks digital photographs will be compared with that at the baseline.
10. Patient’s assessment of improvement will also be recorded for all patients.
11. Physician’s assessment will be classified as excellent, good, and poor. The improvement will be rated as poor, good, and excellent depending on the change in patient’s disease improvement.
12. Patient’s perceptions of improvement will be noted by using the visual analogue scale, where the patient was asked to mark on the line the point that they feel represents their perception of their current state.
13. Differences in final improvement by physician and patient’s perceptions will be analysed at the end of 12 weeks + 1 week or >75% improvement in m-PPPASI score to report percentage matching as successful result of treatment.
14. Group A will be given oral methotrexate 0.3 mg/kg/week not exceeding 25 mg/week while 23 patients in Group B will be given oral tofacitinib 5 mg BD.
 
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