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CTRI Number  CTRI/2023/07/055368 [Registered on: 19/07/2023] Trial Registered Prospectively
Last Modified On: 17/07/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effectiveness and safety of oral steroid compared to tofacitinib in cases of lichen planus involving skin or oral cavity.  
Scientific Title of Study   Effectiveness and safety of oral prednisolone vs tofacitinib in management of oral and mucocutaneous lichen planus: Investigator blind, active-controlled, randomized clinical trial.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rhitam Ghosal 
Designation  2nd Year Post Graduate Trainee, Department of Oral and Maxillofacial Pathology 
Affiliation  Guru Nanak Institute of Dental Sciences and Research 
Address  Department of Oral and Maxillofacial Pathology, Ground Floor, Guru Nanak Institute of Dental Sciences and Research
157/F Nilgunj Road, Panihati , Sodepur, Kolkata, Pin: 700114, West Bengal
North Twentyfour Parganas
WEST BENGAL
700114
India 
Phone  7003202179  
Fax    
Email  rkg3894@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nilay Kanti Das 
Designation  Professor and Head, Department of Dermatology  
Affiliation  College of Medicine and Sagore Dutta Hospital 
Address  Department of Dermatology, OPD building, 2nd Floor, room no 5
578, B.T. Road, Kamarhati, Kolkata, West Bengal 700058 , India
North Twentyfour Parganas
WEST BENGAL
700058
India 
Phone  9433394148  
Fax    
Email  drdasnilay@gmail.com  
 
Details of Contact Person
Public Query  
Name  Rhitam Ghosal 
Designation  2nd Year Post Graduate Trainee, Department of Oral and Maxillofacial Pathology 
Affiliation  Guru Nanak Institute of Dental Sciences and Research 
Address  Department of Oral and Maxillofacial Pathology, Ground Floor, Guru Nanak Institute of Dental Sciences and Research
157/F Nilgunj Road, Panihati , Sodepur, Kolkata, Pin: 700114, West Bengal
North Twentyfour Parganas
WEST BENGAL
700114
India 
Phone  7003202179  
Fax    
Email  rkg3894@gmail.com  
 
Source of Monetary or Material Support  
College of Medicine and Sagore Dutta Hospital 
 
Primary Sponsor  
Name  College of Medicine and Sagore Dutta Hospital 
Address  578, B.T. Road, Kamarhati, Kolkata, West Bengal 700058 , India 
Type of Sponsor  Research institution and hospital 
 
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 Rhitam Ghosal  College of Medicine and Sagore Dutta Hospital  Department of Dermatology, OPD building, 2nd Floor, room no 5, 578, B.T. Road, Kamarhati, Kolkata, West Bengal 700058 , India
North Twentyfour Parganas
WEST BENGAL 		 7003202179

rkg3894@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee, College of Medicine and Sagore Dutta Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L43||Lichen planus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Oral Prednisolone  • Patient will be provided regime of oral prednisolone (0.5mg/kg/day) at the baseline visit. At the 6th week follow-up visit tapering of dose will be done, which will be 10mg for 3weeks followed by 5mg/week  
Intervention  Tofacitinib   At the baseline visit tofacitinib(5mg twice/day) would be given as regimen. At the 2nd week patient would be inquired about the side-effects of the drug, effectiveness parameters would be noted. Patient will be provided with the same regime for another 4 weeks. At the end of 6th week tofacitinib dosage would be terminated.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. All clinically and histologically proven cases of oral lichen planus (OLP) with or without dermatological manifestations
2. Patients suffering from lichen planus who have not responded to topical therapy and conventional treatment.
3. Recurring cases of lichen planus
4. No use of any systemic therapy in patients suffering from lichen planus in the previous 4 weeks prior to enrolment in the study
5. Patients willing to come for follow up at regular intervals
 
 
ExclusionCriteria 
Details  1. Extremes of age comprising children below the age of 18years and elderly patients above the age of 65 years will be excluded from the study.
2. Pregnant and lactating women
3. Patients with asymptomatic OLP
3. Patients with uncontrolled diabetes mellitus, hypertension
4. Patient under immunosuppressive drugs.
5. Patients with concomitant immune disorders, heart disease, renal failure, malignancy
6. Patients with neurological or psychiatric disorders.
7. Patients who have participated in any clinical trial within the last 3 months.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the Lichen Planus Activity & Damage Index (LiPADI).
The adverse event complained by the patients
b. Adverse event noted by the investigator
c. Biochemical, Hematological examination findings 		 0 week baseline visit
2nd week follow up visit
6th week follow up visit
12th week follow up visit  
 
Secondary Outcome  
Outcome  TimePoints 
To assess the quality of life of the patients through Oral Health Impact Profile-14 (OHIP 14) & Dermatology Life Quality Index ( DLQI )   In Baseline visit, quality of life will be monitored
At the end of 12th week the quality of life will be again checked  
 
Target Sample Size   Total Sample Size="88"
Sample Size from India="88" 
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 4 
Date of First Enrollment (India)   01/08/2023 
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="2"
Months="0"
Days="0" 
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 - NO
Brief Summary    Lichen planus (LP) is a common mucocutaneous disease involving either the skin or mucosa or both. Intra-orally lichen planus manifests as bilateral white striations, papules, or plaques on the buccal mucosa, tongue, and gingivae. Cutaneous LP manifest as pruritic, polygonal, flat-topped, violaceous papules affecting mostly the flexural areas of the body. The oral and cutaneous LP can occur in combination. The incidence of Lichen Planus is less well-characterized anddisplays considerable geographical heterogeneity as it ranges between 14 and 250 cases/100,000 person/year. Cutaneous Lichen Planus has been reported to range between 0.2and 1.0% of the adult population. A cell-mediated immune response is mainly implicated in the pathogenesis of Lichen Planus. As OLP is considered a T cell‐mediated disease associated with a Th1 imbalance of cytokine production, most of the therapeutic interventions have aimed to target the inflammatory pathway underlying OLP. The mainstay medications in management of OLP are anti‐inflammatory drugs. The most commonly used anti‐inflammatory medication is glucocorticosteroids, commonly called corticosteroids. Though the molecular pathogenesis of LP is not completely understood; however, Janus kinase signaltransducer and activator of transcription (JAK-STAT) dependent cytokines such as interferongamma (IFN-γ) are postulated to play a role in disease pathogenesis. Mucosal LP is often difficult to treat, particularly when extensive erosions are present. The JAK inhibitor tofacitinib has been used to treat 10 patients with lichen planopilaris, a scarring alopecia that has some histologic features that are similar to LP. Other authors have also previously postulated that JAK inhibition might be useful in management of Lichen Planus. Based partly on the above data and partly on the success of JAK inhibition in the treatment of other recalcitrant inflammatory skin diseases the present study will be undertaken to evaluate the effectiveness, safety and tolerability of oral prednisolone vs tofacitinib drug in management of oral lichen planus and mucocutaneous lichen planus.
The study will be an institution based, investigator blind, active controlled, randomized clinical trial. The present research study will be conducted in the College of Medicine & Sagore Dutta Hospital (CMSDH), Kolkata, West Bengal during the period of 2023-2025.
Inclusion Criteria: 1. All clinically and histologically proven cases of oral lichen planus (OLP) with or without dermatological manifestations. 2. Patients suffering from lichen planus who have not responded to topical therapy and conventional treatment. 3. Recurring cases of lichen planus 4. No use of any systemic therapy in patients suffering from lichen planus in the previous 4 weeks prior to enrolment in the study. 5. Patients willing to come for follow up at regular intervals. 
Exclusion Criteria: 1. Extremes of age comprising children below the age of 18years and elderly patients above the age of 65 years will be excluded from the study. 2. Pregnant and lactating women 3. Patients with asymptomatic OLP 3. Patients with uncontrolled diabetes mellitus, hypertension 4. Patient under immunosuppressive drugs. 5. Patients with concomitant immune disorders, heart disease, renal failure, malignancy 6. Patients with neurological or psychiatric disorders. 7. Patients who have participated in any clinical trial within the last 3 months. Eligible participants after screening will be randomized into either Group A (Receiving oral prednisolone 0.5mg/kg/day) or Group B (Receiving Tofacitinib 5mg twice/day) with allocation ratio 1:1 as per the randomization sequence. Participants from both the groups will have their oral and dermal health related quality of life evaluated using a questionnaire. (OHIP-14 questionnaire and DLQI). Sample size was calculated to be 88 participants ( Group A 44 patients and Group B 44 patients ) .  Physician blinding will be achieved by having separate dispensing and assessing physician. The assessing physician will not be knowing about the medication dispensed. The assessment will be done by a single physician throughout the study. The allocation concealment will be done by Sequentially Numbered Opaque Sealed Envelope (SNOSE) technique. The patients will be given to sign informed consents before entry into the study. Their blood profile, Lipid and Urea profile, Chest x rays will be checked to match the inclusion criteria before enrollment. the patients will then be administered doses of Prednisolone (group A) and Tofacitnib(Group B) depending on the randomization sequence to be either in Group A or B. follow up visits will be conducted in 2 weeks, 6 weeks, 12 weeks and their effectiveness parameters, side effects,  severity index of the disease, quality of life would be monitored in these visits. 
 
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