Systemic Treatment Options for Generalized Lichen Planus

Phase 2

Not yet recruiting

• Conditions: Lichen Planus
• Interventions: Drug: Methotrexate (drug); Drug: Acitretin

• Registration Number: NCT06739551
• Lead Sponsor: Sheikh Zayed Medical College

Brief 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.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-05
• Study Start: 2024-12-10
• Study First Submitted QC: 2024-12-17
• Last Update Submitted: 2024-12-17
• Study First Posted: 2024-12-18
• Last Update Posted: 2024-12-18
• Primary Completion: 2025-03-15
• Study Completion: 2025-03-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

• Age: 18-60 years
• Gender: both male and female
• Type of Lichen planus: generalized lichen planus
• Patients not taking prior treatment in last 1 month

Exclusion Criteria

• Pregnancy and lactating females
• Bleeding disorders
• Abnormal liver function tests
• Platelet count less than 100000
• Hypersensitivity to Methotrexate or Acitretin
• Unrealistic expectations

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral methotrexate group (Group A)	Methotrexate (drug)	Patients with generalized lichen planus will be given 10 mg per week
Oral Acitretin group (Group B)	Acitretin	Patients with generalized lichen planus will be given oral acitretin 50 mg once daily

Primary Outcome Measures

Name	Time	Method
Efficacy of oral methotrexate vs. oral acitretin in the treatment of generalized lichen planus	Clinical assessment for efficacy will be done 4 weekly for 12 weeks.	Efficacy will be assesssed clinically at each follow up visit. Final efficacy of each treatment will be determined at last follow up visit( i.e. at 12 th week after start of treatment).The final efficacy will be divided into following groups on the basis of clinical resolution of disease: 1. Remission: It is defined as complete resolution of all lesions leaving behind normal skin or post inflammatory pigmentation.; 2. Improvement: It is defined as a more than 50% decrease of the disease, as clinically measured by the surface area from the baseline.; 3. No improvement: It is defined as less than a 50% improvement in the disease, as measured clinically by the surface area from the baseline.

Trial Locations

Locations (1)

Sheikh zayed Medical College and Hospital; 🇵🇰 Rahim Yar Khan, Punjab, Pakistan