| 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
|
|
|
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
|
|
|
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. |