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COMPARISON OF TWO DRUGS IN THE TREATMENT OF ORAL LICHEN PLANUS

A prospective randomised study comparing the efficacy and safety of oral cyclosporine versus oral steroids in the management of refractory cases of oral lichen planus

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/03/050453
Enrollment
60
Registered
2023-03-07
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L438- Other lichen planus

Interventions

Intervention1: CYCLOSPORINE: Cyclosporine is a nonmyelotoxic immunosuppressant whose primary target is the helper/inducer T lymphocyte. By inhibiting the helper/inducer T cells, cyclosporine may inter

Sponsors

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1.Healthy adults aged between 18 to 60 years. 2.Symptomatic patients having only Oral involvement of Lichen Planus which is biopsy proven and has not responded to any topical therapy for 3 months.(ODSS score >30)

Exclusion criteria

Exclusion criteria: 1.Patients having extraoral involvement of Lichen Planus and erosive type of Lichen Planus 2.Patients with uncontrolled or severe hypertension, diabetes mellitus 3.Patients with active or recurrent infections, severe respiratory, renal, hepatic or heart disease 4.Patients with underlying endocrine or hematopoietic disorders 5.Patients who have a habit of tobacco chewing, beetle nut chewing and smoking.

Design outcomes

Primary

MeasureTime frame
Efficacy of Oral Cyclosporine vs Oral Steroid in the treatment of Oral Lichen Planus.Timepoint: At baseline,a monthly follow up of the patient for three months ,followed by 2 monthly visits for the next 6 months.

Secondary

MeasureTime frame
Safety of Oral Cyclosporine vs Oral Steroid in the treatment of Oral Lichen PlanusTimepoint: At the end of follow up,that is at 9 months.

Countries

India

Contacts

Public ContactADITHYA PRAKASH

Ims and Sum Hospital

ajayajena@soa.ac.in9437909933

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026