| 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
|
|
|
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
|
|
|
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. |