| CTRI Number |
CTRI/2025/02/080312 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
31/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Advantages and Disadvantages of Topical Tofacitinib in Chronic Hand Eczema |
|
Scientific Title of Study
|
Efficacy and safety of Topical Tofacitinib in hand eczema
A quasi experimental single armed study
|
| 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 TANISHA NAYAK |
| Designation |
Post Graduate Resident Department of Dermatology |
| Affiliation |
IMS & SUM HOSPITAL BHUBANESWAR |
| Address |
Department of dermatology,venereology and leprosy Institute of Medical Science And Sum Hospital K8 kalinganagar ghatikia khordha 751003
Khordha
ORISSA
751003
India |
| Phone |
07978286893 |
| Fax |
|
| Email |
tanisha.nayak1999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR BIKASH RANJAN KAR |
| Designation |
Professor and HOD Department of Dermatology |
| Affiliation |
IMS & SUM HOSPITAL BHUBANESWAR |
| Address |
Department of dermatology,venereology and leprosy Institute of Medical Science And Sum Hospital K8 kalinganagar ghatikia khordha 751003
Khordha
ORISSA
751003
India |
| Phone |
09937428181 |
| Fax |
|
| Email |
bikashkar@soa.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
DR TANISHA NAYAK |
| Designation |
Post Graduate Resident Department of Dermatology |
| Affiliation |
IMS & SUM HOSPITAL BHUBANESWAR |
| Address |
Department of dermatology,venereology and leprosy Institute of Medical Science And Sum Hospital K8 kalinganagar ghatikia khordha 751003
Khordha
ORISSA
751003
India |
| Phone |
07978286893 |
| Fax |
|
| Email |
tanisha.nayak1999@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Private 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 TANISHA NAYAK |
INSTITUTE OF MEDICAL SCIENCES AND SUM HOSPITAL |
Department of dermatology, venereology and leprosy Institute of Medical Science And Sum Hospital K8 kalinganagar ghatikia khordha 751003
Khordha
ORISSA |
7978286893
tanisha.nayak1999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE ,INSTITUTE OF MEDICAL SCIENCES AND SUM HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L308||Other specified dermatitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Efficacy of Topical Tofacitinib in Chronic Hand eczema |
Topical Tofacitinib will be given to all patient .Effectiveness and safety will be recorded based on Hand eczema severity score index |
| Comparator Agent |
No comparator agent was used |
No comparator agent was used |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
patients of hand eczema diagnosed clinically or histopathologically
hand eczema lasting for more than or equal to 3 months or with two episodes per year
age more than 18 years |
|
| ExclusionCriteria |
| Details |
preganancy and lactation
very severe hand eczema( hand eczema severity index score more than 117)
patient on concurrent systemic immunosuppressive or with in last 4 weeks
patient on concurrent topical immunomodulators/immunosuppressants or within last 4 weeks
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To find out the efficacy of topical tofacitinib in treatment of chronic hand eczema |
Base line second week fourth week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the safety of topical tofacitinib in treatment of chronic hand eczema |
1 month |
|
|
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 2 |
|
Date of First Enrollment (India)
|
19/06/2025 |
| 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="0"
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
|
This is a quasi-experimental single armed study to asses the safety and efficacy of topical tofacitinib in chronic hand eczema .All the patient recruited after meeting the inclusion criteria detailed history including duration of disease ,history of atopy treatment history will be taken. All the patient will be given Topical Tofacitinib to apply along with bland emollient and antihistaminic .patient will be asked to follow up first in 2nd week then again finally in 4th week .Hand eczema severity score will be calculated at the baseline again in 2nd and 4th week .Clinical photographs will be taken in every visit .Dermatologically life quality index will be recorded at base line and at the 4th week . |