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IRCT20221101056374N1 IRCT 2022-11-15 Tehran University of Medical Sciences studing the therapeutic effect of baricitinib and its side effects in LPP (Lichen Plano Pilaris) studing the therapeutic effect of baricitinib and its side effects and comparing it with clobetasol in LPP (Lichen Plano Pilaris) 2022-12-22 anticipated 22 Complete https://irct.ir/trial/66677 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random assignment to intervention and control groups: Participants in this study based on the random sequence determined by the statistical software in the form of simple randomization and in such a way that each person has the same chance as the other participants in one of the two The control group (treatment group with local lotion of clobetasol) or intervention (treatment group with baricitinib oral tablet 4 mg) will be placed, Blinding description: After each patient was visited by the health care providers and the treatment was continued or changed for them (according to the discretion of the health care providers, who are aware of the study and the patient's treatment group and were not blinded), each patient went to the data collection officials (individuals who evaluate the patient to determine the disease activity index and record related information) will be that these data collectors will not know what treatment the patient is undergoing (they are blinded) and those who analyze the data and the Data Safety and Monitoring Committee and those who prepare the draft of the article are blinded to the study in the same way and considering that they do not know which treatment group each data belongs to. 3 lichen planopilaris. Intervention 1: Intervention group: tablet baricitinib 4 miligram daily oral intake. Intervention 2: Control group: clobetasol topical lotion 0.05% once daily ,topical. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No decision has been made yet
public Fateme Ghaseminia
Vahdat eslami street. Razi hospital
tehran Iran (Islamic Republic of) ۱۱۹۹۶۶۳۹۱۱ +98 913 350 1258 f.ghaseminia@gmail.com Tehran University of Medical Sciences scientific Fateme Ghaseminia
Vahdat eslami street. Razi hospital
tehran Iran (Islamic Republic of) ۱۱۹۹۶۶۳۹۱۱ +98 913 350 1258 f.ghaseminia@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Age between 15 and 70 years Acceptance of all provisions of informed consent regarding the plan Absence of contraindications for baricitinib use, including chronic renal failure with GFR below 30, severe liver failure, sensitivity to baricitinib, severe anemia with hemoglobin below 8, lymphopenia with an absolute lymphocyte count below 500, or neutropenia with an absolute neutrophil count below 1000, pregnancy and breastfeeding Not being pregnant and not taking OCP Severe and expanding multifocal disease that is a candidate for receiving systemic medication according to the opinion of the main executive of the plan. Not taking drugs that interact with baricitinib The patient's consent to enter the plan 15 years 70 years Both For any reason, the patient does not agree to enter the plan For any reason, the patient does not agree with the provisions of informed consent in the plan Contraindications to baricitinib use include chronic renal failure with GFR below 30, severe liver failure, sensitivity to baricitinib, severe anemia with hemoglobin below 8, lymphopenia with an absolute lymphocyte count below 500, or neutropenia with an absolute neutrophil count below 1000, pregnancy and breastfeeding Pregnancy or OCP consumption Local and limited disease that is not a candidate for receiving systemic and immunosuppressive drugs according to the opinion of the main executive of the plan. Taking drugs that interfere with baricitinib 12 Chapter XII Diseases of the skin and subcutaneous tissue(L00-L99) Treatment - Drugs Treatment - Drugs Intervention group: tablet baricitinib 4 miligram daily oral intake Control group: clobetasol topical lotion 0.05% once daily ,topical Percentage reduction of LICHEN PLANOPILARIS ACTIVITY INDEX score. Timepoint: At the beginning of the study (before the start of the intervention) and 2, 4 and 6 months after the start of the study. Method of measurement: Lichen planopilaris disease activity index questionnaire. Aspartate aminotransferase. Timepoint: The beginning of the study (before the start of the intervention) and 2, 4, and 6 months after the start of the study. Method of measurement: blood test. Alanine aminotransferase. Timepoint: The beginning of the study (before the start of the intervention) and 2, 4, and 6 months after the start of the study. Method of measurement: blood test. Alkaline phosphatase. Timepoint: The beginning of the study (before the start of the intervention) and 2, 4, and 6 months after the start of the study. Method of measurement: blood test. Creatinine. Timepoint: The beginning of the study (before the start of the intervention) and 2, 4, and 6 months after the start of the study. Method of measurement: blood test. Blood urea nitrogen. Timepoint: The beginning of the study (before the start of the intervention) and 2, 4, and 6 months after the start of the study. Method of measurement: blood test. Complete blood count. Timepoint: The beginning of the study (before the start of the intervention) and 2, 4, and 6 months after the start of the study. Method of measurement: blood test. Tehran University of Medical Sciences Approved 2022-10-30 Ethics committee of Tehran University of Medical Sciences Tehran, Keshavarz Blvd., Corner of Qods St., Central Organization of the University, 6th Floor, Research and Technology Vice-Chancellor, Ethical Committee Secretariat Tehran Tehran Iran (Islamic Republic of)