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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.


 
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