| CTRI Number |
CTRI/2024/05/067768 [Registered on: 21/05/2024] Trial Registered Prospectively |
| Last Modified On: |
16/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
methotrexate versus dexamethasone iontophoresis in palmoplantar psoriasis
|
|
Scientific Title of Study
|
A comparative study on therapeutic Efficacy between Methotrexate versus Dexamethasone Iontophoresis in 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 |
Dr K DESINGH |
| Designation |
post graduate |
| Affiliation |
Thanjavur Medical College |
| Address |
Room no. 18,
Department of Dermatology venereology and leprosy,
Thanjavur Medical college,
Thanjavur
Thanjavur
TAMIL NADU
613004
India |
| Phone |
9663282405 |
| Fax |
|
| Email |
desingh99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
R Karpagavalli |
| Designation |
Assistant professor |
| Affiliation |
Thanjavur Medical College |
| Address |
Department of Dermatology,
Room No. 19
Thanjavur Medical College,
Thanjavur
Thanjavur
TAMIL NADU
613004
India |
| Phone |
9095544411 |
| Fax |
|
| Email |
carp2002@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
R Karpagavalli |
| Designation |
Assistant professor |
| Affiliation |
Thanjavur Medical College |
| Address |
Room no. 19,
Department of Dermatology,
Thanjavur Medical College,
Thanjavur
Thanjavur
TAMIL NADU
613004
India |
| Phone |
9095544411 |
| Fax |
|
| Email |
carp2002@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. K. Desingh (self)
Room no.18,
Department of Dermatology,
Thanjavur medical college,
Thanjavur - 613004 |
|
|
Primary Sponsor
|
| Name |
Dr DesinghK |
| Address |
Department of Dermatology,
Room No. 18,
Thanjavur medical college,
Thanjavur- 613004. |
| 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 |
| DrDesingh |
Thanjavur medical college |
Room NO. 18,
Department of Dermatology,
Thanjavur medical college
Thanjavur
TAMIL NADU |
9663282405
desingh99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Thanjavur Medical College Institutional Ethical committee for Human studies |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
dexamethasone solution iontophoresis |
treatment with topical application of solution of dexamethasone 8mg in 2ml using iontophoresis machine for bilateral hands or feet patients with in palmoplamntar psoriasis |
| Intervention |
methotrexate solution (injection form) iontophoresis |
treatment with topical application of methotrexate 50 mg in 2ml solution applied for bilateral hands or feet using iontophoresis machine.
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Bilateral palmoplantar psoriasis not on systemic immunosupressants.
2. Patients who are not desirous of conception during study period.
3. Age 20 yrs – 60 yrs
4. Both sexes
5. Patient willing for regular follow up
|
|
| ExclusionCriteria |
| Details |
1. Patient not willing to participate in the study.
2. Pregnant and lactating women
3. Haematological & hepatic disorder patients.
Patients with pacemaker, metallic intrauterine device.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| improvement in the modified PASI Score after 8 weeks of treatment |
baseline, 4 weeks, 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess whether dexamethasone sodium phosphate iontophoresis is an effective local therapy for psoriasis.
|
2 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 1 |
|
Date of First Enrollment (India)
|
01/06/2024 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
|