| CTRI Number |
CTRI/2025/08/092626 [Registered on: 07/08/2025] Trial Registered Prospectively |
| Last Modified On: |
05/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
tofacitinib
versus topical calcipotriol as an adjuvant
therapy in chronic plaque psoriasis. |
|
Scientific Title of Study
|
Comparative efficacy of topical tofacitinib
versus topical calcipotriol as an adjuvant
therapy in chronic plaque psoriasis. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aarshia Bajaj |
| Designation |
Postgraduate Junior Resident |
| Affiliation |
Government Medical College and Hospital, Sector 32, Chandigarh |
| Address |
Department of Dermatology, Venereology and Leprosy
Level 5, Block-D,
Government Medical College and Hospital, Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
8295986675 |
| Fax |
|
| Email |
aarshia.bajaj@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Mala Bhalla |
| Designation |
Professor |
| Affiliation |
Government Medical College and Hospital, Sector 32, Chandigarh |
| Address |
Department of Dermatology, Venereology and Leprosy
Level 5, Block-D,
Government Medical College and Hospital, Sector 32, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121545 |
| Fax |
|
| Email |
malabhalla@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aarshia Bajaj |
| Designation |
Postgraduate Junior Resident |
| Affiliation |
Government Medical College and Hospital, Sector 32, Chandigarh |
| Address |
Department of Dermatology, Venereology and Leprosy
Level 5, Block-D,
Government Medical College and Hospital, Sector 32, Chandigarh
CHANDIGARH
160030
India |
| Phone |
8295986675 |
| Fax |
|
| Email |
aarshia.bajaj@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College and Hospital, Sector 32, Chandigarh, India, 160030 |
|
|
Primary Sponsor
|
| Name |
Government Medical College and Hospital |
| Address |
Government Medical College and Hospital Sector 32 Chandigarh 160030 |
| 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 Aarshia Bajaj |
Government Medical College and Hospital Sector 32 Chandigarh |
Department of Dermatology Venereology and Leprosy
Level 4, Block B
Government Medical College and Hospital Sector 32 Chandigarh 160030
Chandigarh
CHANDIGARH |
8295986675
aarshia.bajaj@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE(GMCH, Chandigarh) |
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 |
Topical Calcipotriol 0.005% Ointment + Topical corticosteroid (betamethasone dipropionate 0.05%) |
Topical calcipotriol 0.005% ointment applied once daily at night along with betamethasone dipropionate 0.05% cream once daily in the morning local application for 12 weeks.
Dose in finger tip units according to the body surface area of the individual patient. |
| Intervention |
Topical Tofacitinib 2% Ointment + Topical corticosteroid (betamethasone dipropionate 0.05%) |
Topical tofacitinib 2% ointment applied once daily at night along with betamethasone dipropionate 0.05% cream once daily in the morning local application for 12 weeks.
Dose in finger tip units according to the body surface area of the individual patient |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with chronic plaque psoriasis not requiring systemic medication
|
|
| ExclusionCriteria |
| Details |
Non-plaque forms of psoriasis
History or evidence of psoriatic arthritis
Use of any systemic agent or phototherapy in the last 2 weeks
Any co-existing serious systemic illness requiring long-term medication
Any infection requiring hospitalization within the past 2 weeks
Pregnancy/lactation |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Percentage reduction in Psoriasis Area and Severity Index (PASI) score |
at 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients achieving PASI 50 & PASI 75 responses |
At baseline & 12 weeks |
| Change in Physician’s Global Assessment (PGA) score |
Baseline and 12 weeks |
| Change in patient satisfaction scores |
Baseline and 12 weeks |
| Incidence of adverse effects and overall tolerability |
Baseline to 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/10/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
40 patients with chronic plaque psoriasis that
fulfil the inclusion criteria shall be recruited
and randomised with the help of random table
method into two groups:
Mid-potency topical corticosteroid cream
(betamethasone dipropionate) shall be used in
all patients for once daily application, applied
in the morning.
Group A will receive topical tofacitinib 2%
ointment once daily application, applied at
night. Group B will receive topical calcipotriol
0.005% ointment once daily application,
applied at night.
|