| CTRI Number |
CTRI/2025/07/090447 [Registered on: 08/07/2025] Trial Registered Prospectively |
| Last Modified On: |
07/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the effect of Tablet Apremilast with Tablet Tofacitinib in Psoriasis vulgaris treatment. |
|
Scientific Title of Study
|
A comparitive study on the therapeutic efficacy of Tablet Apremilast and Tablet Tofacitinib in the treatment of chronic plaque type 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 Abirami T |
| Designation |
Postgraduate |
| Affiliation |
Thanjavur Medical College |
| Address |
Room No 32
Department of DVL
Thanjavur Medical College
Thanjavur
Thanjavur
TAMIL NADU
613004
India |
| Phone |
9884717848 |
| Fax |
|
| Email |
abits02@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Balajiganesh |
| Designation |
Assistant Professor |
| Affiliation |
Thanjavur Medical College |
| Address |
Room No 20
Department of DVL
Thanjavur Medical College
Thanjavur
Thanjavur
TAMIL NADU
613004
India |
| Phone |
9865639594 |
| Fax |
|
| Email |
drbalajikmu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Balajiganesh |
| Designation |
Assistant Professor |
| Affiliation |
Thanjavur Medical College |
| Address |
Room No 20
Department of DVL
Thanjavur Medical College
Thanjavur
Thanjavur
TAMIL NADU
613004
India |
| Phone |
9865639594 |
| Fax |
|
| Email |
drbalajikmu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Out patient department
Department of DVL
Thanjavur Medical College Thanjavur Pincode 613004 Tamilnadu India |
|
|
Primary Sponsor
|
| Name |
Dr Abirami T |
| Address |
Room No 32
Department of DVL
Thanjavur Medical College
Thanjavur pincode 613004
Tamilnadu India |
| 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 Abirami T |
Thanjavur Medical College |
Room Number 32
Department of DVL
Outpatient department
Thanjavur Medical College
Thanjavur Pincode 613004 Tamilnadu India
Thanjavur
TAMIL NADU |
9884717848
abits02@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Thanjavur Medical College Institutional Ethical Committee For Human Studies |
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 |
| Intervention |
Tablet Apremilast 30 mg OD |
Group A will be given Tablet Apremilast 30mg OD daily |
| Comparator Agent |
Tablet Apremilast 30mg OD
Tablet Tofacitinib 5mg BD |
Group A will be given Apremilast 30 mg OD daily and Group B will be given 5mg BD
and we will compare both group and find out therapeutic efficacy of both the drug |
| Intervention |
Tablet Tofacitinib 5mg BD |
Group B will be given Tablet Tofacitinib 5mg BD daily |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
Patients having plaque type psoriasis
Patients who are willing to give consent to participate in the study
Patients who could come for regular follow up |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating mothers
Patients with severe liver and kidney diseases
Immunocompromised patients
History of previous treatment
History of known allergy to any drugs
Concomitant use of CYP-450 inhibitors or inducers |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
80 percent power
95 percent confidence interval
P value
|
Psoriasis Area Severity Index
Patients clinical response at baseline and at 4 weeks and at 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3 |
|
Date of First Enrollment (India)
|
18/07/2025 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Plaque psoriasis is most common form of psoriasis making up over 80 percent of cases It usually affects the scalp trunk and extremities It manifests as erythematous plaque with silvery white scales Active treatment can successfully reduce symptoms and even achieve a clinical cure To date there are no direct comparative studies between Apremilast and Tofacitinib in the treatment of chronic plaque psoriasis Hence this study is novel to detect therapeutic efficacy |