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CTRI Number  CTRI/2025/09/095351 [Registered on: 24/09/2025] Trial Registered Prospectively
Last Modified On: 22/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to study the effects and adverse effects of two drugs,Tofacitinib and Methotrexate in patients with Lichenplanus. 
Scientific Title of Study   A COMPARATIVE study to evaluate efficacy and adverse effects of Oral Tofacitinib and Oral Methotrexate in Lichen Planus. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SAMADHI JAYASREE SAILAKSHMI  
Designation  Postgraduate Student 
Affiliation  Maharajahs institute of medical sciences  
Address  Department of DVL, Maharajahs institute of medical sciences, Nellimarla,Vizianagaram,Andhra Pradesh.

Vizianagaram
ANDHRA PRADESH
535217
India 
Phone  7993951027  
Fax    
Email  sjssailakshmi413@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR.PENUMETSA VENKATA KRISHNAMRAJU 
Designation  Professor  
Affiliation  Maharajahs institute of medical sciences  
Address  Room no 25,Department of DVL, Maharajahs institute of medical sciences, Nellimarla,Vizianagaram,Andhra Pradesh.

Vizianagaram
ANDHRA PRADESH
535217
India 
Phone  9701936999  
Fax    
Email  Pvkraju.vzm@gmail.com  
 
Details of Contact Person
Public Query
 
Name  SAMADHI JAYASREE SAILAKSHMI  
Designation  Postgraduate Student 
Affiliation  Maharajahs institute of medical sciences  
Address  Department of DVL, Maharajahs institute of medical sciences, Nellimarla,Vizianagaram,Andhra Pradesh.

Vizianagaram
ANDHRA PRADESH
535217
India 
Phone  7993951027  
Fax    
Email  sjssailakshmi413@gmail.com  
 
Source of Monetary or Material Support  
Maharajahs institute of medical sciences  
 
Primary Sponsor  
Name  Maharajahs institute of medical sciences  
Address  Maharajahs institute of medical sciences,Nellimarla,Vizianagaram 535217 
Type of Sponsor  Private 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 Samadhi JAYASREE SAILAKSHMI   Maharajahs institute of medical sciences   Room no 25,Department of Dermatology (DVL),Maharajahs institute of medical sciences,Nellimarla,Vizianagaram,535217
Vizianagaram
ANDHRA PRADESH 
7993951027

sjssailakshmi413@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee Maharajahs institute of medical sciences   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L430||Hypertrophic lichen planus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Oral Methotrexate   10mg weekly once per oral for 3 months. 
Intervention  Oral TOFACITINIB   5mg,BD per oral for 3 months  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  All Patients between age of 18 to 60 yrs with clinical and Dermoscopic features suggestive of Lichen Planus.
Patients of all genders.
All the patients who give their consent to the study.
 
 
ExclusionCriteria 
Details  Special variants of LP like Mucosal LP,Lichen Planus pigmentosus, and Follicular LP.
Patients who are already used topical therapy for last 2 weeks and systemic therapy for last 4 weeks for lichen Planus.
Patients having abnormal Haematological parameters,LFT and RFT.
Patients with active or past history of tuberculosis,Immunodeficiency states (HIV patients,those who were on immunosuppressants and corticosteroids).
Pregnancy and lactation.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Decreased visual analog scale
Increased patient satisfaction score will be assessed at baseline,4 weeks and 8 weeks 
Adverse effects will be noted at baseline,4 weeks and 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 2 
Date of First Enrollment (India)   10/10/2025 
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 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  

INTRODUCTION 


Lichen planus is an idiopathic,inflammatory &  autoimmune mucocutaneous condition characterised by violaceous,polygonal,pruritic,flat topped,scaly papules & plaques commonly seen on flexural creases of body,lowerback,oral mucosa and also on scalp &nails.[1]It has a recurrent course and on healing leaves a post inflammatory hyper pigmentation and rarely scarring.[2]It is estimated to affect 0.5% to 2% of general population with no racial variation.Most common in middle aged adults with an female predominance.[2,3,4]

Despite the use of Multiple immunosuppressant drugs included oral corticosteroids,Treatment of Lichenplanus is challenging in view of frequent recurrences , repeated disease exacerbations and Possible adverse effects.

In this background to compare the efficacy and adverse effects of Older conventional drug  methotrexate with Newer immunomodulator drug Tofacitinib in Lichen planus.

 


 AIM AND OBJECTIVES


To study the efficacy and adverse effects of Oral Tofacitinib and Oral Methotrexate in  Lichen Planus.


DATA COLLECTION /SAMPLE METHODS :


  • After taking informed consent,the patient’s Age,Sex,Address,Occupation and other demographic data will be noted.


  • Detailed history regarding onset of disease, Disease duration,symptoms and any drug history will be taken.


  • In all patients thorough dermatological examination will be performed taking note of the Type of skin lesions and distribution of lesions all over the body.


  • Dermoscopy will be done to evaluate the diagnosis.


  • Lab investigations like CBC, RFT,LFT, Viral screening and Mantoux test will be done in all patients.



  • Patients will be divided into 2 Groups based on  sequence provided by statistician.


  • Group A will be treated with Methotrexate 10mg (0.2mg/kg body weight) for 3 months.


  • Group B will be treated with Tofacitinib 5mg BD for 3 months.


  • At baseline, all patients’ photographic documentation will be done with patients consent and severity of the disease will be evaluated based on physician visual analog scale.



  • At an interval of 4 weeks at each visit ,Photographic documentation will be taken with patients consent and patient satisfaction with the treatment will be assessed using Likert scale,while physicians evaluated the outcome using a visual analog scale.


  • Final assessment will be done at  the end of 12 weeks,decrease in likert scale compared to baseline and decrease in physician visual analog scale compared to baseline will be calculated to know the efficacy of the treatment.


  • Adverse effects if any will be noted at each review visit and final visit.

 


STASTICAL ANALYSIS :


  • A paired student’s t-test will be utilised to compare means before and after the treatment,while a student’s unpaired t-test will be employed to compare means between different procedures.
  • For all statistical analysis p<0.05 will be considered as statistically significant.


                                   


 
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