| CTRI Number |
CTRI/2024/04/066155 [Registered on: 23/04/2024] Trial Registered Prospectively |
| Last Modified On: |
05/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study to find better drug among injection methotrexate and injection triamcinolone acetonide in patients of psoriasis |
|
Scientific Title of Study
|
A comparative study on efficacy of intralesional methotrexate vs intralesional triamcinolone acetonide in chronic plaque 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 |
Sampath V |
| Designation |
Professor |
| Affiliation |
Madras medical college |
| Address |
OPD no: 47,
Department of Dermatology, Madras medical college,
Rajiv Gandhi Government General Hospital.
Chennai
TAMIL NADU
600003
India |
| Phone |
9444117234 |
| Fax |
|
| Email |
sampv11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Raghul kumar J |
| Designation |
post-graduate |
| Affiliation |
Madras medical college |
| Address |
OPD no: 47,
Department of Dermatology, Madras medical college,
Rajiv Gandhi Government General Hospital,
Chennai
TAMIL NADU
600003
India |
| Phone |
8148158911 |
| Fax |
|
| Email |
raghulkumarjs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Raghul kumar J |
| Designation |
post-graduate |
| Affiliation |
Madras medical college |
| Address |
OPD no: 47,
Department of Dermatology, Madras medical college,
Rajiv Gandhi Government General Hospital
Chennai
TAMIL NADU
600003
India |
| Phone |
8148158911 |
| Fax |
|
| Email |
raghulkumarjs@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Dermatology,
Madras Medical college,
Rajiv Gandhi Government General Hospital,
Chennai - 600003
Tamilnadu, India |
|
|
Primary Sponsor
|
| Name |
Sampath V |
| Address |
Professor, Department of Dermatology, Madras medical college, Rajiv Gandhi Government General Hospital,
Chennai-600003, Tamil Nadu, India |
| Type of Sponsor |
Other [Principal investigator of the study] |
|
|
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 |
| Raghulkumar J |
Rajiv Gandhi Government General Hospital |
OPD no: 47,
Department of Dermatology, Madras medical college,
Chennai
TAMIL NADU |
8148158911
raghulkumarjs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE MADRAS MEDICAL COLLEGE, CHENNAI 600003 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L400||Psoriasis vulgaris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intralesional methotrexate |
Intralesional injection to be given at site of chronic plaque psoriasis,
1 plaque will be injected per sitting
Dose: 25mg/ml per plaque per sitting
Frequency: 3 doses 2 weeks apart (0,2 and 4 weeks)
Route: Subcutaneous injection
Total duration: 4 weeks
All 3 injection will be given to a single plaque |
| Comparator Agent |
Intralesional triamcinolone acetonide |
Intralesional injection to be given at site of chronic plaque psoriasis,
1 plaque per sitting
Dose: 10mg/ml (maximum 20mg per sitting)
Frequency: 3 doses 2 weeks apart (0,2 and 4 weeks)
Route: Subcutaneous injection
total duration: 4 weeks
All 3 injections will be given on a single plaque |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) All patients with clinical features of chronic Plaque psoriasis with less than 5 Plaques
2) Patients who have given consent for the study and are willing to come for regular follow up at the psoriasis clinic.
3) Patients who had not been on any systemic and topical anti psoriatic medications for at least the past 2 months will be enrolled.
|
|
| ExclusionCriteria |
| Details |
1) Patients with unstable psoriasis
2) Pregnant and Lactating Women
3) Patients of Psoriasis vulgaris with history of Hypersensitivity to MTX or Triamcinolone.
4) Patients with bleeding disorders and on anti-coagulant therapy. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. To compare the efficacy of intralesional Methotrexate (MTX) and Triamcinolone in the treatment of Chronic plaque psoriasis both clinically and using Dermoscopy. |
6 weeks,12 weeks,24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 2. To compare the common side effects of Intralesional Methotrexate and Triamcinolone Acetonide in Chronic Plaques Psoriasis. |
6 weeks,12 weeks,24 weeks |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
Final Enrollment numbers achieved (Total)= "86"
Final Enrollment numbers achieved (India)="86" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
07/05/2024 |
| Date of Study Completion (India) |
30/11/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - NO
|
Brief Summary
Modification(s)
|
In Chronic Plaque Psoriasis, Intralesional therapy can be used, as it delivers a higher concentration of the medicine at the site of injection while avoiding the recognized side effects of systemic therapy. The drawback of Topical treatment is inadequate drug penetration. This drawback is nullified by intralesional therapy. |