| CTRI Number |
CTRI/2020/10/028555 [Registered on: 22/10/2020] Trial Registered Prospectively |
| Last Modified On: |
21/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
STUDY THE EFFICACY AND SIDE EFFECTS OF SUBCUTANEOUS V/S ORAL METHOTREXATE IN THE MANAGEMENT OF MODERATE TO SEVERE PSORIASIS AND PALMOPLANTAR PSORIASIS |
|
Scientific Title of Study
|
EFFICACY AND TOLERABILITY OF SUBCUTANEOUS V/S ORAL METHOTREXATE IN THE MANAGEMENT OF MODERATE TO SEVERE PSORIASIS AND PALMOPLANTAR PSORIASIS - A HOSPITAL BASED PROSPECTIVE RANDOMIZED CONTROLLED COMPARATIVE STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pooja K H |
| Designation |
Resident |
| Affiliation |
Krishna institue of medical science, Karad |
| Address |
Krishna institute of medical science, Karad, Maharashtra 415539
Krishna institute of medical science, Karad, Maharashtra 415539
Satara
MAHARASHTRA
415539
India |
| Phone |
9535420428 |
| Fax |
|
| Email |
pooja.kanumuru@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohan S Kale |
| Designation |
Professor and head of department |
| Affiliation |
Krishna institue of medical science, Karad |
| Address |
Krishna institute of medical science, Karad, Maharashtra 415539
Krishna institute of medical science, Karad, Maharashtra 415539
Satara
MAHARASHTRA
415539
India |
| Phone |
9535420428 |
| Fax |
|
| Email |
docmsk2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pooja K H |
| Designation |
Resident |
| Affiliation |
Krishna institue of medical science, Karad |
| Address |
Krishna institute of medical science, Karad, Maharashtra 415539
Krishna institute of medical science, Karad, Maharashtra 415539
Satara
MAHARASHTRA
415539
India |
| Phone |
9535420428 |
| Fax |
|
| Email |
pooja.kanumuru@gmail.com |
|
|
Source of Monetary or Material Support
|
| Krishna institute of medical sciences, Karad |
|
|
Primary Sponsor
|
| Name |
DrPooja |
| Address |
Department of dermatology, Kims, Karad |
| 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 Pooja Kanumuru |
Krishna institiute of medical sciences, Karad |
OPD 29, Department of dermatology
Satara
MAHARASHTRA |
9535420428
pooja.kanumuru@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Krishna institute of medical sciences, Karad |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy individuals with chronic plaque psoriasis and palmoplantar psoriasis |
| Patients |
(1) ICD-10 Condition: L409||Psoriasis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Injection Methotrexate subcutaneous 15mg versus Oral methotrexate 5mg tablet |
Group A: Tablet 0.3-0.5mg/kg body weight/week
Group B: Injectable 0.3-0.5mg/kg body weight/week
|
| Intervention |
Injection Methotrexate subcutaneous versus Oral methotrexate tablet in patients with chronic plaque psoriasis and palmoplantar psoriasis |
Group A: Tablet 0.3-0.5mg/kg body weight/week for 3 months
Group B: Injectable 0.3-0.5mg/kg body weight/week for 3 months
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
a) diagnosed to be suffering from Moderate to Severe Psoriasis and palmoplantar psoriasis or palmoplantar psoriasis clinically in
DERMATOLOGY OPD of a tertiary care centre in Karad
b) Have completed 18 years of age.
c) Have not taken any treatment, two months prior to the inclusion in study.
|
|
| ExclusionCriteria |
| Details |
1. Hemoglobin < 8 gm/dl ,Total leukocyte count < 3500/ mm3, Platelet count < 100,000/mm3
2. Elevation of hepatic enzymes (alanine aminotransferase [ALT], aspartate aminotransferase [AST]) to more than twice the upper limit of normal or any deranged liver function tests.
3. Hepatitis, active or recurrent, cirrhosis or excessive current alcohol intake.
4. Use of other hepatotoxic drugs by the patient
5. Positive hepatitis B, hepatitis C or HIV serology
6. Pulmonary or extra-pulmonary active tuberculosis
7. Deranged renal function test.
8. Pregnancy or lactation or if patient is planning to conceive during the treatment period.
9. Patient on other immunosuppressive drugs
10. Recent live vaccination
11. Unreliable patient
12. Patients unwilling for monthly follow-ups.
13. Patient with known hypersensitivity to drug.
14. Patient with unrealistic expectation |
|
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Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in primary efficacy variables: PASI in chronic plaque psoriasis, m-PASI in palmoplantar psoriasis |
7th day, 30th day, 60th, 90th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in secondary efficacy variables like VAG,PGA and DLQI in chronic plaque psoriasis, VAG,PGA,PPQOL in palmoplantar psoriasis |
7th day, 30th day, 60th, 90th day |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/10/2020 |
| Date of Study Completion (India) |
07/08/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
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
|
None |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This will be a prospective investigator blind randomized controlled comparative study in patients of moderate to severe psoriasis and palmoplantar psoriasis attending Dermatology OPD of a tertiary care centre over a period of 1 year. Patient with moderate to severe psoriasis (PASI 10 and above),Palmoplantar psoriasis fulfilling the inclusion and exclusion criteria will be selected. Informed consent will be taken. Before treatment patients will be examined thoroughly using clinical and laboratory measures for any underlying disease.Use of concomitant topical or systemic treatment that could affect the outcome of the disease condition will not be permitted until the end of the study. After baseline evaluation of Psoriasis Area & Severity Index(PASI) DLQI (Dermatology life quality index), Physician Global Assessment (PGA), Visual Analogue Scale (VAS), Modified Psoriasis Area Severity Index(Modified PASI), Psoriasis severity scale (PSS), Palmoplantar quality of life instrument (PPQOL) and blood investigations by investigator, patients will then be allotted Group A and Group B via randomnisation. Thus each subgroup will have equal number of patients in each group. Group A- The selected patients will be administered oral Methotrexate (0.3-0.5mg/kg bodyweight) per week Group B- The selected patients will be administered Injectable Methotrexate (0.3-0.5mg/kg bodyweight) per week
Patients will be strictly instructed not to disclose the format, i.e. name of drugs or method of drug administration to the investigator by any form.Patient will be asked to follow up regularly for both the groups to assess safety and efficacy.At each visit patient will be assessed by investigator for efficacy by Psoriasis Area & Severity Index(PASI), DLQI (dermatology life quality index), Physician Global Assessment (PGA), Visual Analogue Scale (VAS) in psoriasis group.Whereas palmoplantar group will be assessed for efficacy at each visit by Modified Psoriasis Area Severity Index(Modified PASI), Psoriasis severity scale (PSS), Palmoplantar quality of life instrument (PPQOL), Physician Global Assessment (PGA), Visual Analogue Scale (VAS). To assess the safety profile of drugs laboratory investigations will be ordered as per the visit schedule and noted by investigator. |