Systemic Treatment Options for Generalized Lichen Planus

Sheikh Zayed Medical College

Status and phase: Not yet enrolling; Phase 2

Conditions: Lichen Planus

Treatments: Drug: Methotrexate (drug); Drug: Acitretin

Study type: Interventional

Funder types: Other

Identifiers

NCT06739551

SheikhZMC/H

Details and patient eligibility

About

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.

Full 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.

Enrollment: 124 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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124 participants in 2 patient groups

Oral methotrexate group (Group A)

Active Comparator group

Description:

Patients with generalized lichen planus will be given 10 mg per week

Treatment:

Drug: Methotrexate (drug)

Oral Acitretin group (Group B)

Active Comparator group

Description:

Patients with generalized lichen planus will be given oral acitretin 50 mg once daily

Treatment:

Drug: Acitretin