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
|
|
Primary Sponsor
|
Name |
NIL |
Address |
NIL |
Type of Sponsor |
Other [] |
|
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 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
|
|
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
|
|
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. |