| 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
|
|
|
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
|
|
|
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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