FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/11/096803 [Registered on: 03/11/2025] Trial Registered Prospectively
Last Modified On: 01/11/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Clinical Trial To Study Safety And Efficacy Of Two Topical Drugs- Tofacitinib And Crisaborole For Atopic Eczema 
Scientific Title of Study   A Double Blind Randomized Study To Evaluate Safety And Efficacy Of Tofacitinib And Crisaborole For Topical Management Of Mild To Moderate Atopic Eczema 
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 Rubina Sultana 
Designation  Post Graduate Trainee 
Affiliation  School of Tropical Medicine 
Address  Department of Dermatology, 108 Chittaranjan Avenue, School of Tropical Medicine, Kolkata

Kolkata
WEST BENGAL
700073
India 
Phone  9083220090  
Fax    
Email  sultanarubina786@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Gourab Roy  
Designation  Assistant professor , Department of Dermatology 
Affiliation  School of Tropical Medicine 
Address  Department of Dermatology, School of Tropical Medicine, 108 Chittaranjan Avenue, Kolkata

Kolkata
WEST BENGAL
700073
India 
Phone  8777089072  
Fax    
Email  drroydermacare@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rubina Sultana 
Designation  Post Graduate Trainee, Department of Dermatology 
Affiliation  School of Tropical Medicine 
Address  Department of Dermatology, School of tropical medicine, 108 Chittaranjan Avenue Kolkata

Kolkata
WEST BENGAL
700073
India 
Phone  9083220090  
Fax    
Email  sultanarubina786@gmail.com  
 
Source of Monetary or Material Support  
Department of Dermatology, School of tropical medicine, 108, Chittaranjan Avenue, Kolkata - 700073. West Bengal  
 
Primary Sponsor  
Name  School of Tropical Medicine,Kolkata 
Address  108 Chittaranjan Avenue,College Square,Kolkata-700073 
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 Rubina Sultana  Calcutta School Of Tropical Medicine  108,Chittaranjan Avenue, Calcutta School Of Tropical Medicine, Department Of Dermatology Venereology And Leprosy, Kolkata-700073
Kolkata
WEST BENGAL 		 9083220090

sultanarubina786@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Clinical Research ethics Committee-School Of Tropical Medicine  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L209||Atopic dermatitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Topical Crisaborole (2%)  Applied topically twice daily over eczematous lesion for 6 weeks 
Intervention  Topical Tofacitinib (2%)  Applied topically twice daily over eczematous lesion for 6 weeks 
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All cases of mild to moderate Atopic eczema  
 
ExclusionCriteria 
Details  1) Patient unwilling to participate
2) Severe Atopic Eczema
3) Active forms of other eczematous or dermatitis, history of disseminated or recurrent herpes zoster infection
4) Severely ill patients requiring hospitalization less than 6 months prior to the study
5) Any active infection
6) On treatment -oral or topical less than 2 weeks prior to the study
7) History of lymphoproliferative disorders or malignancies.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare safety and efficacy of Tofacitinib and Crisaborole for topical management of mild to moderate Atopic Eczema  6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate an effective long term steroid free topical maintenance therapy for management of mild to moderate eczema  6 weeks 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
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   N/A 
Date of First Enrollment (India)   18/11/2025 
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="1"
Days="15" 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sultanarubina786@gmail.com].

  6. For how long will this data be available start date provided 30-11-2025 and end date provided 31-10-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study is a double blind ,parallel group randomized trial to be conducted in Department of Dermatology, School of Tropical medicine ,Kolkata to compare the safety and efficacy of Tofacitinib and Crisaborole for  topical management of mild to moderate eczema for 6 weeks (follow up done every 2 weeks) in 64 patients. The primary outcome measures the safety and efficacy of these drugs for management of Atopic eczema . Secondary outcomes measures how effective  these drugs can be as a long term  alternative to  Topical steroids free  maintenance therapy. 
Close