| CTRI Number |
CTRI/2023/10/058439 [Registered on: 09/10/2023] Trial Registered Prospectively |
| Last Modified On: |
02/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to assess the effects of two drugs,topical methotrexate gel and topical mometasone furoate ointment in patients with psoriasis. |
|
Scientific Title of Study
|
Comparative study of topical methotrexate gel 1% and topical mometasone furoate ointment 0.1% in the treatment of stable 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 |
Dr Shivani |
| Designation |
Academic Junior resident |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
Department of Dermatology,OPD complex ,2nd Floor,
Indira Gandhi Institute of Medical Sciences,Bailey road,Sheikhpura,Patna,Bihar 800014.
Patna
BIHAR
800014
India |
| Phone |
8521871620 |
| Fax |
|
| Email |
drshivani4847@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Sinha |
| Designation |
Additional professor and HOD |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
Department of Dermatology,OPD complex ,2nd Floor,
Indira Gandhi Institute of Medical Sciences,Bailey road,Sheikhpura,Patna,Bihar 800014.
Patna
BIHAR
800001
India |
| Phone |
7764049225 |
| Fax |
|
| Email |
sinhaderma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivani |
| Designation |
Academic Junior Resident |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
Department of Dermatology,OPD Complex 2nd floor,Indira Gandhi Institute of Medical Sciences,Bailey road,Sheikhpura,Patna,Bihar 800014
Patna
BIHAR
800014
India |
| Phone |
8521871620 |
| Fax |
|
| Email |
drshivani4847@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Institute of Medical Sciences Patna |
|
|
Primary Sponsor
|
| Name |
Dr Shivani |
| Address |
Department of Dermatology,OPD complex ,2nd Floor,
Indira Gandhi Institute of Medical Sciences,Bailey road,Sheikhpura,Patna,Bihar 800014. |
| 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 Shivani |
Indira Gandhi Institute of Medical Sciences,Patna,Bihar |
Department of Dermatology,Room No.224-230 OPD complex ,2nd Floor.
Patna
BIHAR |
8521871620
drshivani4847@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
Topical Methotrexate gel 1% |
Group B will receive topical Methotrexate gel 1% twice daily for 8 weeks |
| Comparator Agent |
Topical Mometasone furoate ointment (0.1%) |
Group A will receive Topical Mometasone furoate 0.1% ointment twice daily for 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Not using topical psoriasis treatment for at least 2weeks before the start of study.
2.Patients having mild to moderate chronic plaque psoriasis. |
|
| ExclusionCriteria |
| Details |
1.Use of Phototherapy,PUVA or systemic therapy for psoriasis within 8 weeks before the start of study.
2.Pregnant and lactating women and women of child bearing potential who are not practicing an acceptable method of birth control.
4.Patients of unstable,erythrodermic,pustular and guttate psoriasis. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1.Efficacy of topical methotrexate gel 1% and topical mometasone furoate ointment 0.1% in the treatment of psoriasis |
Lesions will be scored at baseline and after 2,4,6 and 8 weeks of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to determine the safety profile,tolerability of topical MTX gel and Mometasone furoate ointment |
At 2,4,6 and 8 weeks of treatment. |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 4 |
|
Date of First Enrollment (India)
|
13/10/2023 |
| 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="6"
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
|
The study will be carried out on patients with mild to moderate stable plaque psoriasis in the department of dermatology at Indira Gandhi Institute of Medical Sciences,Patna.The diagnosis of psoriasis will be made clinically by an expert dermatologist and histopathological examination will be done wherever needed and written and informed consent will be taken.Demographic data and relevant medical history will be obtained from all patients.Patients will be randomly allocated into two groups .Group A will receive topical Mometasone furoate ointment 0.1% twice daily for 8 weeks and Group B will receive topical Methotrexate gel 1% twice weekly for 8 weeks.Lesions will be scored at baseline and after 2,4,6 and 8 weeks of treatment for erythema,scale and induration and DLQI questionnaire will be used to assess the impact on the quality of life of patients at the beginning and end of treatment. |