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CTRI Number  CTRI/2024/07/070275 [Registered on: 09/07/2024] Trial Registered Prospectively
Last Modified On: 25/06/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing efficacy of two different drugs in management of oral lichen planus 
Scientific Title of Study   Efficacy and safety of oral methotrexate vs oral tofacitinib in management of oral lichen planus A prospective randomised 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  Navneet Singh 
Designation  Junior resident 
Affiliation  Shri Bhusaheb Hire Government Medical College  
Address  Department of Dermatology, Venereology and Leprosy, OPD Number 18, Shri Bhausaheb Hire Government Medical College Chakkarbardi, Surat bypass, Dhule Dhule MAHARASHTRA 424001 India

Dhule
MAHARASHTRA
424001
India 
Phone  9013715510  
Fax    
Email  nvnitkatariya31294@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Chetan Rajput 
Designation  Professor and head of department  
Affiliation  Shri Bhusaheb Hire Government Medical College  
Address  Department of Dermatology, Venereology and Leprosy, OPD Number 18, Shri Bhausaheb Hire Government Medical College Chakkarbardi, Surat bypass, Dhule MAHARASHTRA 424001 India

Dhule
MAHARASHTRA
424001
India 
Phone  8888487808  
Fax    
Email  drchetanrajput@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Navneet Singh 
Designation  Junior resident 
Affiliation  Shri Bhusaheb Hire Government Medical College  
Address  Department of Dermatology, Venereology and Leprosy, OPD Number 18, Shri Bhausaheb Hire Government Medical College Chakkarbardi, Surat bypass, Dhule Dhule MAHARASHTRA 424001 India

Dhule
MAHARASHTRA
424001
India 
Phone  9013715510  
Fax    
Email  nvnitkatariya31294@gmail.com  
 
Source of Monetary or Material Support  
Shri Bhausaheb Hire Government Medical College, Dhule Pincode- 424001 Maharashtra India 
 
Primary Sponsor  
Name  Navneet Singh 
Address  Department of Dermatology, Venereology and Leprosy, OPD Number 18, Shri Bhausaheb Hire Government Medical College Chakkarbardi, Surat bypass, Dhule Dhule MAHARASHTRA 424001 India 
Type of Sponsor  Other [Self funded] 
 
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 Navneet Singh  Shri Bhausaheb Hire Government Medical College  Department of Dermatology, Venereology and Leprosy, OPD Number 18, Shri Bhausaheb Hire Government Medical College Chakkarbardi, Surat bypass, Dhule - 424001 Dhule MAHARASHTRA
Dhule
MAHARASHTRA 		 9013715510

nvnitkatariya31294@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Shri Bhausaheb Hire Government Medical College   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L438||Other lichen planus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Oral Methotrexate according to body weight  Patients will receive treatment with oral methotrexate, dosed according to standard clinical guidelines ( first test dose of 2.5 mg is given, followed by complete blood count investigation, if results are within normal limits then methotrexate will be started according to the weight of the patient) for OLP and for a duration of 12 weeks with regular monitoring for response and adverse effects. 
Comparator Agent  Oral Tofacitinib 5mg BD  Patients will receive treatment with oral tofacitinib 5 mg to be taken twice a day for duration of 12 weeks with regular monitoring for response and adverse effects.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients who are diagnosed case of oral lichen planus with or without skin lesions .
2. Both sexes - Male and Female.
3. Age- More than 18 years and less than 60 years 
 
ExclusionCriteria 
Details  1. Age less than 18 years or more than 60 years.
2. Pregnancy, those female patients who are planning for pregnancy in next one month and lactation.
3. Patients unwilling to give consent to be part of trial.
4. Patients with active or latent TB.
5. Patients with anemia, liver disease, kidney disease, GI disease ( diverticulitis, perforation, ulcers ), respiratory disease ( ILD, COPD, pulmonary edema )
6. Patients with malignancies or lymphoproliferative disorders.
7. Patients on potent immunosuppressants, biological DMARDS, H/O organ transplant.
8. Patients with deranged lipid profile.
9. H/O recent live vaccination.
10. Family history of melanoma/non melanoma skin disorders.
11. Alcohol intake, tobacco and smoking.
12. Obesity.
13. H/o any thromboembolic event, cardiovascular disease, stroke. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Primary outcome include evaluation and assessment of therapeutic response of methotrexate and tofacitinib in oral lichen planus according to Thongprasom score.   Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks, Follow up period of 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary outcome include safety profile and tolerability of oral methotrexate and oral tofacitinib in the treatment of oral lichen planus.  Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks, follow up period of 3 months 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
Final Enrollment numbers achieved (Total)= "34"
Final Enrollment numbers achieved (India)="34" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   24/07/2024 
Date of Study Completion (India) 17/06/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 17/06/2026 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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 - Informed Consent Form

  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 [nvnitkatariya31294@gmail.com].

  6. For how long will this data be available start date provided 24-08-2025 and end date provided 23-08-2028?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  		 Oral lichen planus (OLP) is a chronic inflammatory condition marked by erythema, erosions, and purplish plaques exhibiting a distinctive white lacy pattern called Wickham striae on the oral mucosa. Achieving an accurate diagnosis of oral lichen planus necessitates a comprehensive approach involving thorough history-taking, clinical examination, dermoscopy, mucoscopy and histopathological evaluation. While patients displaying the typical reticular form of OLP may have a clinically diagnostic presentation, it is prudent to perform an oral biopsy. Despite its prevalence, there is currently no universally recognized treatment that achieves complete remission of OLP symptoms. This randomized, prospective  study aims to compare the efficacy and safety of oral methotrexate vs oral tofacitinib in the treatment of oral lichen planus. 
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