Lichen Planus
Conditions
Keywords
Lichen Planus, Acitretin, Methotrexate, Efficacy
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.
Interventions
oral methotrexate 10 mg per week for 12 weeks
DRUGAcitretin
oral acitretin 50 mg once daily for 12 weeks
Sponsors
Sheikh Zayed Medical College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Pakistan
Contacts
Primary ContactMohibullah, Post graduate resident
Outcome results
None listed