A Phase 2 interventional study of Methotrexate (drug) and Acitretin in Lichen Planus, sponsored by Sheikh Zayed Medical College. Not yet recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-12-18.
Sponsored by Sheikh Zayed Medical College · Phase 2, Interventional, and Treatment
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.
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.
172 studies on the registry are indexed under Lichen Planus; 22 are open to participants now.
This study's planned enrollment of 124 is above the median of 30 across 123 interventional studies indexed under Lichen Planus.
Browse Lichen Planus studies →Sheikh Zayed Medical College is the lead sponsor of 27 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
Patients with generalized lichen planus will be given 10 mg per week
Drug: Methotrexate (drug)
Patients with generalized lichen planus will be given oral acitretin 50 mg once daily
Drug: Acitretin
oral methotrexate 10 mg per week for 12 weeks
oral acitretin 50 mg once daily for 12 weeks
Efficacy of oral methotrexate vs. oral acitretin in the treatment of generalized lichen planus
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.
Time frame: Clinical assessment for efficacy will be done 4 weekly for 12 weeks.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2024; primary completion for Mar 2025, 3 months later.
Of 23 phase 2 interventional studies under Lichen Planus, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 27. This study's planned 3 months is below that.
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This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Methotrexate · Acitretin
Sheikh Zayed Medical College