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IRCT20190717044256N1 IRCT 2019-08-30 Esfahan University of Medical Sciences The effect of methotrexate and cyclosporine on lichenplanopilaris Clinical trial of comparison of methotrexate versus cyclosporine on disease activity index in patients with lichen planopilaris 2017-09-23 anticipated 32 Complete https://irct.ir/trial/40991 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: patients who have inclusion criteria randomly are divided between two groups ; randomly the first patient belongs to the first group for taking cyclosporine and the second one starts to take methotrexate in second group. Theretofore the end of the study they will be divided between two groups one- to -one insofar each group reaches to 16 patients. 2 Lichen planopilaris. Intervention 1: Intervention group: Methotrexate(15mg/week orally,in one day) will be administered in one group(16 patients) for six months. Intervention 2: Intervention group: Cyclosporine( 300mg/day orally),will be administered in one group(16 patients)for 6 months. No - There is not a plan to make this available Justification or reason for not sharing IPD is In our research enough and appropriate information about patient's demographic data , analysis of before and after indices of LPPAI and global standardized photography will be published as our clinical report .

public Minoo Jelvan,MD

Department of Dermatology, Alzahra hospital, Sofe street, Isfahan, Iran

Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 Minoo.jelvan@gmail.com Esfahan University of Medical Sciences scientific Minoo Jelvan, MD

Department of Dermatology, Alzahra hospital, Sofe street, Isfahan, Iran

Isfahan Iran (Islamic Republic of) 8174645731 +98 31 3620 2020 Minoo.jelvan@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Scalp involvement more than 10% Local disease (<10%Involvement) resistant to 3-month topical treatment or 6-months systemic treatment The patients should be stopped all systemic or topical medications at least one month before enrollment to the study no limit no limit Both Pregnancy lactation Hb<9mg/dl Wbc<4000 Plt<100000 Liver enzymes 3 times more than upper limit of normal Positive viral hepatic tests Renal failure Uncontrolled blood pressure Administration of another immunosuppressive or topical medication by other physicians Elevated serum creatinine >50% or >25% by lower doses of drug(25-50% over 2weeks) L66.1 Lichen planopilaris Treatment - Drugs Treatment - Drugs Intervention group: Methotrexate(15mg/week orally,in one day) will be administered in one group(16 patients) for six months Intervention group: Cyclosporine( 300mg/day orally),will be administered in one group(16 patients)for 6 months Lichen planopilaris activity. Timepoint: Before and after 2,4,6 months after intervention. Method of measurement: Checklist of criteria in lichen planopilaris activity index ; Lichen planopilaris activity index is measured by this formula:LPPAI = (itch + pain + burn ) / 3 + (scalp erythema + perifollicular erythema +perifollicular scale) / 3 + 2.5(pull test) + 1.5(spreading / 2). Standardized global photography. Timepoint: Before and after intervention. Method of measurement: Based on scoring by two dermatologists. Esfahan University of Medical Sciences Approved 2018-05-30 Ethics Committee of Isfahan university of medical sciences Hezarjarib street Isfahan Isfehan Iran (Islamic Republic of)