CTRI Number |
CTRI/2019/08/020569 [Registered on: 06/08/2019] Trial Registered Prospectively |
Last Modified On: |
02/08/2019 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Comparative trial of two topical preparations in palmoplantar psoriasis |
Scientific Title of Study
|
A randomised, double-blind, comparative trial of topical Methotrexate 1% gel along with topical urea emollient versus topical Clobetasol propionate 0.05% ointment along with topical urea containing emollient in mild to moderate variety of palmoplantar psoriasis |
Trial Acronym |
METCLOP |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Prasun Kumar Ghosh |
Designation |
Junior Resident |
Affiliation |
Department of Dermatology, KPC Medical College and Hospital |
Address |
Room No. 53
1F Raja Subodh Chandra Mullik Road
Kolkata WEST BENGAL 700032 India |
Phone |
9073860336 |
Fax |
|
Email |
prasunkumarg@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Sujata Sengupta |
Designation |
Assistant Professor |
Affiliation |
Department of Dermatology, KPC Medical College and Hospital |
Address |
Room no. 53
1F Raja Subodh Chandra Mullik Road
Kolkata WEST BENGAL 700032 India |
Phone |
9830165267 |
Fax |
|
Email |
senguptasujata@yahoo.co.in |
|
Details of Contact Person Public Query
|
Name |
Anupam Das |
Designation |
Assistant Professor |
Affiliation |
Department of Dermatology, KPC Medical College and Hospital |
Address |
Room No. 53
1F Raja Subodh Chandra Mullik Road
Kolkata WEST BENGAL 700032 India |
Phone |
9674852138 |
Fax |
|
Email |
anupamdasdr@gmail.com |
|
Source of Monetary or Material Support
|
KPC Medical College and Hospital
1F Raja Subodh Chandra Mullik Road, Kolkata 700032 |
|
Primary Sponsor
|
Name |
KPC Medical College and Hospital |
Address |
1F Raja Subodh Chandra Mullik Road, Kolkata 700032 |
Type of Sponsor |
Research institution and hospital |
|
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 |
PRASUN KUMAR GHOSH |
KPC Medical College and Hospital |
Department of Dermatology
Room No. 53
1F Raja Subodh Chandra Mullik Road Kolkata WEST BENGAL |
9073860336
prasunkumarg@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee, KPC Medical College and Hospital |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: L408||Other psoriasis, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Topical Clobetasol propionate 0.05% ointment AND urea containing emollient |
Topical Clobetasol propionate 0.05% ointment twice daily AND urea containing emollient twice daily, for 12 weeks |
Intervention |
Topical Methotrexate 1% gel AND Urea containing emollient |
Topical Methotrexate 1% gel twice daily plus AND Urea containing emollient twice daily, for 12 weeks |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
80.00 Year(s) |
Gender |
Both |
Details |
Males and females aged 18 to 80 years, with mild to moderate palmoplantar psoriasis |
|
ExclusionCriteria |
Details |
Pregnant and nursing females
Patients with Diabetes, malignancy, hepatic and renal dysfunction
History of hypersensitivity to any drug
Those previously treated for psoriasis in last 3 months
Patients not willing to comply with protocol requirements |
|
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 |
Number of lesions
Erythema
Scaling
PASI score |
Week 0,2,4,6,8,10,12 |
|
Secondary Outcome
|
Outcome |
TimePoints |
Quality of Life (DLQI) |
Week 0,2,4,6,8,10,12 |
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
19/08/2019 |
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="0" 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
|
Palmoplantar psoriasis is a localised
form of psoriasis which accounts for 3-4% of all psoriasis cases and produces
significant functional and social disability. It is a chronic recurring disease
which may exist in the absence of psoriasis lesions in other parts of the body.
So, a randomised ,double-blind comparative trial is being planned in the Out
Patient Department of Department of Dermatology in KPC Medical College and Hospital, Jadavpur, to
compare the effectiveness and safety of
topical Methotrexate 1%gel with urea containing emollient versus topical Clobetasol propionate 0.05% ointment with
urea containing emollient in mild to moderate palmoplantar psoriasis.
In palmoplantar psoriasis, emollients
are used in conjunction with topical therapies provide a promising synergistic
remedy. Application of emollients hinders water evaporation from skin, increasing
hydration in stratum corneum and consequently reducing scaling and erythema
associated with psoriasis. Due to their therapeutic effects that improve patient
comfort, emollients are used as an adjunct in topical therapies.
Screening is to be done after
obtaining written consent. Eligible patients will be randomised into group A
and B, and provided with respective medications in both groups. As there is no
significant comparative study between
topical Methotrexate 1% gel and topical Clobetasol propionate 0.05% ointment
,we intend to compare their effectiveness and safety in mild to moderate
palmoplantar psoriasis.
|