| CTRI Number |
CTRI/2019/04/018841 [Registered on: 30/04/2019] Trial Registered Prospectively |
| Last Modified On: |
29/04/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
Comparative study of 2 topical agents (creams) for treatment of psoriasis |
|
Scientific Title of Study
|
Comparative study of topical Methotrexate gel(1%) vs Clobetasol propionate cream (0.05%) in palmoplantar psoriasis and chronic plaque psoriasis : An Open Label Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SONAL HEMNANI |
| Designation |
PG 1st year RESIDENT DERMATOLOGY |
| Affiliation |
PEOPLES COLLEGE OF MEDICAL SCIENCES AND RESEARCH CENTER BHOPAL |
| Address |
DEPARTMENT OF DERMATOLOGY
PEOPLES COLLEGE OF MEDICAL SCIENCES AND RESEARCH CENTER
BHANPUR
BHOPAL
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9893054720 |
| Fax |
|
| Email |
sonalhemnani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MEETESH AGRAWAL |
| Designation |
ASSOCIATE PROFESSOR DERMATOLOGY |
| Affiliation |
PEOPLES COLLEGE OF MEDICAL SCIENCES AND RESEARCH CENTER BHOPAL |
| Address |
DEPARTMENT OF DERMATOLOGY
PEOPLES COLLEGE OF MEDICAL SCIENCES AND RESEARCH CENTER
BHANPUR
BHOPAL
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
|
| Fax |
|
| Email |
drmeetesh@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DR SONAL HEMNANI |
| Designation |
PG 1st year RESIDENT DERMATOLOGY |
| Affiliation |
PEOPLES COLLEGE OF MEDICAL SCIENCES AND RESEARCH CENTER BHOPAL |
| Address |
DEPARTMENT OF DERMATOLOGY
PEOPLES COLLEGE OF MEDICAL SCIENCES AND RESEARCH CENTER
BHANPUR
BHOPAL
Bhopal
MADHYA PRADESH
462037
India |
| Phone |
9893054720 |
| Fax |
|
| Email |
sonalhemnani@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR SONAL HEMNANI
OPD NO.8
DEPARTMENT OF DERMATOLOGY
PEOPLES COLLEGE OF MEDICAL SCIENCES AND RESEARCH CENTRE
BHANPUR
BHOPAL 462037 |
|
|
Primary Sponsor
|
| Name |
DR SONAL HEMNANI |
| Address |
PEOPLES COLLEGE OF MEDICAL SCIENCES AND RESEARCH CENTER
BHANPUR
BHOPAL |
| 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 SONAL HEMNANI |
PEOPLES HOSPITAL |
OPD NO.8,
DEPARTMENT OF DERMATOLOGY
PEOPLES HOSPITAL
BHANPUR BHOPAL
Bhopal
MADHYA PRADESH |
9893054720
sonalhemnani@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 |
| Comparator Agent |
CLOBETASOL PROPIONATE CREAM (0.05%) |
USE OF CLOBETASOL PROPIONATE CREAM (TOPICAL STEROID) IN PALMOPLANTAR PSORIASIS AND CHRONIC PLAQUE PSORIASIS FOR 8 WEEKS |
| Intervention |
METHOTREXATE GEL(1%) |
USE OF TOPICAL METHOTREXATE GEL IN PALMOPLANTAR PSORIASIS AND CHRONIC PLAQUE PSORIASIS FOR 8 WEEKS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1.PATIENT WITH LESIONS COVERING >30% OF PALMS AND SOLES (PALMOPLANTAR PSORIASIS) OR CHRONIC PLAQUE PSORIASIS WITH INVOLVEMENT OF BODY SURFACE AREA <20%
2.PATIENT WHO GIVE THEIR CONSENT FOR THE STUDY
3.WOMEN IF WILLING TO AVOID CONCEPTION DURING THE STUDY AND FOR 4 MONTHS SUBSEQUENT TO THE STUDY |
|
| ExclusionCriteria |
| Details |
1.Patients of age <18 years
2.Involvement of >20% Body Surface Area where systemic therapy is needed
3.Pregnant/Breast feeding females.
4.Patients on NB-UVB
5.Patients who had taken topical antipsoriatic medication except bland emollients in 2 weeks or more before enrollment
6.Patients who had taken systemic antipsoriatic medication in 1 month or more before enrollment
7.Patients with haematological/renal/ hepatic dysfunction.
8.Patients who didn’t gave their consent for the study or have not shown willingness for follow up.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| EFFICACY AND SAFETY OF METHOTREXATE GEL IN TREATMENT OF PALMOPLANTAR PSORIASIS AND CHRONIC PLAQUE PSORIAISIS |
8 WEEKS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
ERYTHEMA, INDURATION, SCALING FOR PALMOPLANTAR PSORIASIS
PASI SCORE FOR CHRONIC PLAQUE PSORIASIS |
2,4,6 WEEKS |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/05/2019 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Psoriasis does result in a lot of concern to the
patient because of the itching and cosmetic appearance.There are very few
studies that have been conducted comparing various topical agents being used
for palmoplantar psoriasis and chronic plaque psoriasis.The rationale of this
study is to compare one of the most commonly used topical steroid-clobetasol
with methotrexate gel,a topical form of oral drug that has been used for
treatment of psoriasis. The hypothesis for the research question is To compare the
efficacy and safety of topical methotrexate gel (1%) in comparison to
clobetasol propionate cream(0.05%) for the treatment of palmoplantar psoriasis
and chronic plaque psoriasis. |