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CTRI Number  CTRI/2025/06/088150 [Registered on: 03/06/2025] Trial Registered Prospectively
Last Modified On: 03/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   ORAL METHOTREXATE AND ORAL BETAMETHASONE MINI PULSE IN LICHEN PLANUS 
Scientific Title of Study   EFFICACY AND SAFETY OF ORAL METHOTREXATE AND ORAL BETAMETHASONE MINI PULSE IN THE TREATMENT OF LICHEN PLANUS : A RANDOMISED CONTROL 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  Moparty pavani aiswarya 
Designation  JUNIOR RESIDENT 
Affiliation  kalinga institute of medical sciences 
Address  Department of dermatology, Kalinga Institute of Medical Sciences, Campus -5, KIIT Road, Patia, Bhubaneswar, ODISHA.
Kalinga Institute of Medical Sciences, Campus -5, KIIT Road, Patia, Bhubaneswar, ODISHA.
Khordha
ORISSA
751024
India 
Phone  8978312598  
Fax    
Email  aiswaryamoparty@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Laxman besra 
Designation  Associate professor  
Affiliation  kalinga institute of medical sciences 
Address  DEPARTMENT OF DERMATOLOGY, KALINGA INSTITUTE OF MEDICAL SCIENCES, CAMPUS -5, KIIT ROAD, PATIA, BHUBANESHWAR, ODISHA.

Khordha
ORISSA
751024
India 
Phone  9500282040  
Fax    
Email  laxman.derm@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr.Moparty pavani aiswarya 
Designation  junior resident 
Affiliation  kalinga institute of medical sciences 
Address  Department of dermatology, Kalinga institute of medical sciences, Campus-5 , KIIT road,patia, Bhubaneswar, Odisha. Pincode : 751024

Khordha
ORISSA
751024
India 
Phone  8978312598  
Fax    
Email  aiswaryamoparty@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [] 
 
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 Moparty pavani aiswarya  Kalinga Institute Of Medical Sciences  DEPARTMENT OF DERMATOLOGY, Room. no.17,1st floor, A Block KALINGA INSTITUTE OF MEDICAL SCIENCES, CAMPUS -5, KIIT ROAD, PATIA, BHUBANESHWAR, ODISHA.
Khordha
ORISSA 
08978312598

aiswaryamoparty@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, KALINGA 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: L439||Lichen planus, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  oral betamethasone mini pulse  oral betamethasone at a mini pulse dose of 5mg on two consecutive days per week 
Intervention  Oral methotrexate  oral methotrexate at a dose of 15mg once weekly and folic acid supplementation 4 days a week 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. All patients giving consent aged between 18-45 years of age.
2. patients with lichen planus having a treatment free period of 2 months. 
 
ExclusionCriteria 
Details  1. active bacterial, viral, mycobacterial, fungal infections or history of malignancies
2. alcoholics and patients with alcoholic liver disease, liver cirrhosis, fibrosis, chronic liver disease.
3.Anemia, neutropenia, lymphopenia.
4. diabetes, hyperlipidaemia, hypertension, renal disease, epilepsy, glaucoma.
5. patients receiving concomitant radiotherapy.
6. pregnant and lactating women 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
lichen planus activity and damage index   4 weeks, 8 weeks and 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
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   N/A 
Date of First Enrollment (India)   24/06/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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 chronic inflammatory disease which affects skin, mucous membranes, scalp and nails with a prevalence of 0.5-2% in general population. Cutaneous LP is characterized by purple, polygonal, flat topped, pruritic papules and plaques. The sites that are commonly affected are flexor surfaces of forearms, wrists, ankles and also the trunk.1 The exact cause of LP is unknown, it is attributed to a number of triggers such as drugs, contact allergens, genetic and immune mechanisms. The immune mechanism targets basal keratinocytes and it is mediated by CD8+, CXCR3+ cytotoxic t cells. There is Th-1 mediated releases of inflammatory cytokines such as interferon-gamma, from the cytotoxic T-cells. Interferon-gamma activity is associated with an increase in the expression of CXCL10, CXCL9 AND CXCL11, at the papillary dermis and dermo epidermal junction.

Histological features of LP are band like lymphocytic infiltrate at the papillary dermis close to the epidermis, vacuolar degeneration of basal keratinocytes and presence of civatte bodies. Corticosteroids form the main stay of therapy for LP2. Localised LP can be treated with high potency topical corticosteroids.  Generalised LP requires treatment with systemic corticosteroids, commonly prednisolone for unresponsive cases, acitretin and UVB phototherapy are used as second line therapy3. Systemic corticosteroids cannot be used for prolonged periods due to their adverse effects such as weight gain, hyperlipidaemia, hyper glycemia, peptic ulcer disease, oesophageal reflux, bowel perforation, Cushing’s disease, Addisonian crisis, cataract and glaucoma4.

A novel approach has been proposed to minimize the side effects of daily dosing regimens in which a single dose of long-acting steroid such as betamethasone is administered 2 days a week. This weekly dosing pulse regimen of low dose steroid is known as oral mini-pulse therapy. Oral mini pulse increases compliance and can be preferred over the standard regimens in patients who are more prone to adverse effects of systemic corticosteroids. Betamethasone 5mg or 6mg once or twice a week is being used routinely5.

Methotrexate [MTX] is an anti- metabolite which is approved for use in malignancies, rheumatoid arthritis, Psoriatic arthritis. In dermatology it is being used for Psoriasis, Sezary syndrome, Immuno-bullous disorders, proliferative disorders, autoimmune connective tissue diseases and vasculitis. Methotrexate is a competitive inhibitor of the enzyme dihydrofolate reductase, which is essential for the synthesis of nucleotides of DNA. As a result, immunosuppression is achieved by inhibition of DNA synthesis in immunologically competent cells. MTX also exerts antiproliferative effect on T-cells. MTX mediated increase in adenosine production reduces inflammation.4

MTX supresses both B and T cell immune responses,4 as a result it is efficacious in LP where there is T-cell mediated destruction of keratinocytes. MTX suppresses the chemotaxis of inflammatory cells6 by virtue of which the chemokines released in LP are supressed. MTX can be used as a safe alternative in cases of LP which are difficult to treat.

 
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