Clinical trial NCT06739551: Systemic Treatment Options for Generalized Lichen Planus
Official title: Comparison of Efficacy of Oral Methotrexate and Acitretin for Generalized Lichen Planus
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Lichen Planus
Keywords: Lichen Planus
Acitretin
Methotrexate
Efficacy
Lead sponsor: Sheikh Zayed Medical College
Sponsor class: OTHER_GOV
First posted: 2024-12-18
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Efficacy of oral methotrexate vs. oral acitretin in the treatment of generalized lichen planus
timeFrame: Clinical assessment for efficacy will be done 4 weekly for 12 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Rahim Yar Khan
country: Pakistan
facility: Sheikh zayed Medical College and Hospital
state: Punjab
Study officials:
References: