NCT06739551

Systemic Treatment Options for Generalized Lichen Planus

Comparison of Efficacy of Oral Methotrexate and Acitretin for Generalized Lichen Planus

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: Sheikh Zayed Medical College · Other Government
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Lichen planus is a chronic inflammatory skin condition with unknown etiology. It requires a long term treatment. Evaulating the most efficacious, safe and affordable treatment option is the need of the hour. This study is going to compare the efficacy of two familiar drugs (acitretin and methotrexate) in the treatment of generalized lichen planus as to find out the relatively more effective and safer treatment.

Detailed description

Lichen planus (LP) is a chronic mucocutaneous condition of an unknown cause. It presents clinically as purple, itchy papules and plaques on the lower back, body folds, oral mucosa, and on the scalp(1). It is recurrent condition with a prolonged course and requires an effective, safer and relatively cheaper treatment option (2). Objective: "To compare the efficacy of oral methotrexate vs. oral acitretin in the treatment of generalized lichen planus". Material \& Methods: This randomized comarative study will be carried out in Outpatient Dermatology Department, Sheikh Zayed Hospital Rahim Yar Khan, Pakistan. Approval of the study has been taken from ethical review committee of the hospital.Data will be collected on prescribed form. Patient will be selected on basis of inclusion \& exclusion criteria. Informed consent will be taken from selected patients before data collection. Study will include 124 patients which will be divided into 2 groups A \& B, 62 in each group. Group A will receive oral methotrexate 10mg once weekly for 12 weeks. Group B will receive oral acitretin 50mg daily for 12 weeks. Folic acid will be given to all patients in group A at a dose of five milligram per day. Patient will be followed at 4 weekly interval and final efficacy will be determined at 12th week.Data will be analyzed by SPSS v25.0.

Conditions

• Lichen Planus

Interventions

Type	Name	Description
DRUG	Methotrexate (drug)	oral methotrexate 10 mg per week for 12 weeks
DRUG	Acitretin	oral acitretin 50 mg once daily for 12 weeks

Timeline

• Start date: 2024-12-10
• Primary completion: 2025-03-15
• Completion: 2025-03-20
• First posted: 2024-12-18
• Last updated: 2024-12-18

Locations

1 site across 1 country: Pakistan