ORAL METHOTREXATE AND ORAL BETAMETHASONE MINI PULSE IN LICHEN PLANUS

Not yet recruiting

Conditions: Lichen planus, unspecified,

Registration Number: CTRI/2025/06/088150

Brief Summary: Lichen planus (LP) is a chronic inflammatory disease whichaffects skin, mucous membranes, scalp and nails with a prevalence of 0.5-2% ingeneral population. Cutaneous LP is characterized by purple, polygonal, flattopped, pruritic papules and plaques. The sites that are commonly affected areflexor surfaces of forearms, wrists, ankles and also the trunk.1 The exactcause of LP is unknown, it is attributed to a number of triggers such as drugs,contact allergens, genetic and immune mechanisms. The immune mechanism targetsbasal keratinocytes and it is mediated by CD8+, CXCR3+ cytotoxic t cells. Thereis Th-1 mediated releases of inflammatory cytokines such as interferon-gamma,from the cytotoxic T-cells. Interferon-gamma activity is associated with anincrease in the expression of CXCL10, CXCL9 AND CXCL11, at the papillary dermisand dermo epidermal junction.

Histological features of LP are band like lymphocyticinfiltrate at the papillary dermis close to the epidermis, vacuolardegeneration of basal keratinocytes and presence of civatte bodies.Corticosteroids form the main stay of therapy for LP2. Localised LP can betreated with high potency topical corticosteroids. Generalised LP requires treatment withsystemic corticosteroids, commonly prednisolone for unresponsive cases, acitretinand UVB phototherapy are used as second line therapy3. Systemic corticosteroidscannot be used for prolonged periods due to their adverse effects such asweight gain, hyperlipidaemia, hyper glycemia, peptic ulcer disease, oesophagealreflux, bowel perforation, Cushing’s disease, Addisonian crisis, cataract andglaucoma4.

A novel approach has been proposed to minimize the sideeffects of daily dosing regimens in which a single dose of long-acting steroidsuch as betamethasone is administered 2 days a week. This weekly dosing pulseregimen of low dose steroid is known as oral mini-pulse therapy. Oral minipulse increases compliance and can be preferred over the standard regimens inpatients 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 approvedfor use in malignancies, rheumatoid arthritis, Psoriatic arthritis. Indermatology it is being used for Psoriasis, Sezary syndrome, Immuno-bullousdisorders, proliferative disorders, autoimmune connective tissue diseases andvasculitis. Methotrexate is a competitive inhibitor of the enzyme dihydrofolatereductase, which is essential for the synthesis of nucleotides of DNA. As a result,immunosuppression is achieved by inhibition of DNA synthesis in immunologicallycompetent cells. MTX also exerts antiproliferative effect on T-cells. MTXmediated increase in adenosine production reduces inflammation.4

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

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

All patients giving consent aged between 18-45 years of age.
patients with lichen planus having a treatment free period of 2 months.

Exclusion Criteria

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.
diabetes, hyperlipidaemia, hypertension, renal disease, epilepsy, glaucoma.
patients receiving concomitant radiotherapy.
pregnant and lactating women.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
lichen planus activity and damage index	4 weeks, 8 weeks and 12 weeks

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (1): Kalinga Institute Of Medical Sciences
🇮🇳
Khordha, ORISSA, India
Kalinga Institute Of Medical Sciences
🇮🇳Khordha, ORISSA, India
Dr Moparty pavani aiswarya
Principal investigator
08978312598
aiswaryamoparty@gmail.com