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CTRI Number  CTRI/2018/04/013351 [Registered on: 19/04/2018] Trial Registered Retrospectively
Last Modified On: 18/04/2018
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Methotrexate with /without topical calcipotriol-which one is better in plaque psoriasis 
Scientific Title of Study   Efficacy and safety of methotrexate alone and as add on to topical calcipotriol in plaque psoriasis. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Moumita Bala 
Designation  Resident 
Affiliation  Institute of Post graduate Medical Education and Research 
Address  Department of Pharmacology, Institute of Post graduate Medical Education and Research 244A AJC Bose Road, kolkata-700020

Kolkata
WEST BENGAL
700020
India 
Phone  8337024704  
Fax    
Email  moumita.bala@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Moumita Bala 
Designation  Resident 
Affiliation  Institute of Post graduate Medical Education and Research 
Address  Department of Pharmacology, Institute of Post graduate Medical Education and Research 244A AJC Bose Road, kolkata-700020

Kolkata
WEST BENGAL
700020
India 
Phone  8337024704  
Fax    
Email  moumita.bala@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Avijit Hazra 
Designation  Professor 
Affiliation  Institute of Post graduate Medical Education and Research 
Address  Department of Pharmacology, Institute of Post Graduate Medical Education & Research 244A AJC Bose Road kolkata-700020

Kolkata
WEST BENGAL
700020
India 
Phone  9831188172  
Fax    
Email  blowfans@yahoo.co.in  
 
Source of Monetary or Material Support  
Department of Pharmacology, IPGMER 
 
Primary Sponsor  
Name  Department of Pharmacology 
Address  IPGMER,244 A,AJC Bose Road, Kolkata-700020 
Type of Sponsor  Government medical college 
 
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 
Dr Moumita Bala  Institute of Post graduate Medical Education and Research  244A, AJC Bose Road, Kolkata 700020
Kolkata
WEST BENGAL 
8337024704

moumita.bala@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IPGME&R Research Oversight Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Plaque Psoriasis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Topical calcipotriol  Topical calcipotriol 0.005% (w/w in ointment base) applied twice daily for total 16 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1.Age more than 18 years of either gender
2.Treatment naive patients of plaque psoriasis
3.Patients of plaque psoriasis receiving methotrexate 
 
ExclusionCriteria 
Details  1.Pregnant and lactating women
2.Patients immunocompromised due to drug or disease/impaired liver/renal/hematological functions
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate and compare the effectiveness and safety of methotrexate alone versus methotrexate with topical calcipotriol  Baseline,4 weeks,8 weeks,16 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To assess and compare the quality of life in plaque psoriasis patients  Baseline and 16 weeks 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
Final Enrollment numbers achieved (Total)= "47"
Final Enrollment numbers achieved (India)="47" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/02/2016 
Date of Study Completion (India) 30/06/2017 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not yet published 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Psoriasis is a common, chronic, proliferative skin disorder usually characterized by sharply demarcated, scaly, indurated plaques, mostly affecting extensor surfaces and scalp. Plaque psoriasis is the most common (approximately 90%) form. Treatment is essentially lifelong and a large proportion of patients require medication changes and regular follow-up. We conducted an observational study comparing two regimens currently being used in our tertiary care hospital for the treatment of resistant plaque psoriasis.

 

Adult patients of plaque psoriasis, of either sex, receiving methotrexate only versus methotrexate along with topical calcipotriol, were enrolled between February 2016 to June 2017. Observation was carried out prospectively over 16 weeks to assess effectiveness in terms of Psoriasis Area & Severity Index (PASI) score, safety and changes in quality of life (QoL).

 

Fifty patients consented to participate, of whom data of 25 on oral methotrexate (dose 5 - 10 mg weekly) alone and 22 on oral methotrexate plus topical calcipotriol 0.005% once/twice daily, were available for analysis. Study participants were mostly middle aged males. The combination group achieved a reduction of 72.75% from baseline in PASI score while methotrexate alone group achieved 54.94% reduction (p < 0.05 on intergroup comparison). No significant adverse reactions were observed over 16 weeks and QoL improvements in the two groups were comparable.

 

Therefore, in conclusion, combination of methotrexate and topical calcipotriol can be a more effective alternative to methotrexate alone in chronic plaque psoriasis.

 
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