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IRCT20191006045005N2 IRCT 2021-03-29 Esfahan University of Medical Sciences Assessing the effectiveness of Methotrexat versus Azathioprine on disease activity index in Lichen planopilaris patients Comparing the effectiveness of Methotrexate versus Azathioprine on disease activity index in Lichen planopilaris patients 2021-04-21 anticipated 32 Complete https://irct.ir/trial/50821 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients are allocated into either the intervention or control group using a non-stratified block randomization method to keep an even randomization ratio of (1:1). Random Allocation Software is used by our expert analytics to determine the list and group of patients. He is blinded to the selection process and pre-and post-operative assessments. The block size will be equal and is set to 4, the sufficient and estimated sample size will be 32, then the allocation code is set to sequential. The analytics will use the output of software to determine the sequence and allocation of patients. Then each code is written on a non-transparent envelope and a paper is put in it in which the intervention or control is written on the paper. The series of the envelope will be according to the software's list and they will keep in a large box with a locker. The analytics has the key for the box and this box will be kept in his room which the analytics has its only key and has no windows. As the patients enrolled in the study sequentially, the analytics use the designated envelope. The mechanism of randomization and block size will not be revealed to the principal investigator and other involved physicians, Blinding description: This study will conduct as double-blind manner. At the beginning for each patient, a summary of pathophysiology and common treatment paths will be clarified. Then they will sign the informed consent to be treated in any of our groups by chance. The patients and their dermatologists who are present in all follow-up visits at the clinic and supervising the follow-up sessions and evaluating variables of treatment and other involved physicians in the clinic will be blinded. Only another non-involved researcher purchase the drugs from pharmaceutical companies and assigns them to group A and B and give them to the physician without interfering in the selection process or contacting the patients. 3 Lichen planopilaris. Intervention 1: Intervention group 1: 16 patients, Methotrexate oral tablet (anti-neoplastic) made by Zahravi Pharmaceutical Co. 15 mg/week for 6 month. Intervention 2: Intervention group 2: 16 patients, Azathioprine oral tablet (2mg/kg/day) for 6 months from Ramopharmin Pharmaceutical Co. Yes - There is a plan to make this available What will be shared: Dissemination of data that has nothing to do with the personality and identity of the participants in the study and they are merely the consequences of study. When: Start the access period after the article is published. To whom: The data will only be available to approved academic researchers after their authentication by the relevant university. Conditions: The data can only be used for research and writing review article. Where to obtain: The author will be available via the email and university phone number mentioned in the article. How to obtain: Allows access to dataif found the data is requested for non-industrial and non-comercial use. Comments:
public Parisa Hajheidari
No168,Abasabad street,Azar street,Isfahan,Iran
Isfahan Iran (Islamic Republic of) 8184854413 0098 31 2365742 parisahajheidarii@resident.mui.ac.ir Esfahan University of Medical Sciences scientific Mina Saber
Dermatology department,Alzahra hospital,Sofe street,Isfahan,Iran
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 mina.saber33@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients with local disease that does not respond to topical treatment after one month Patients with extensive scalp involvement as the first line treatment. Patients should have discontinued any previous systemic medication 1 month prior to admission to the study. Ages 18-65 18 years 65 years Both Pregnancy or lactation Leukocytes less than 3000 (leukopenia of any etiology) Platelets less than 100000 Hemoglobin less than 9 Liver enzymes more than 2 time the reference limit Positive for viral hepatitis tests Consumption of Allopurinol L66.1 Lichen planopilaris Treatment - Drugs Treatment - Drugs Intervention group 1: 16 patients, Methotrexate oral tablet (anti-neoplastic) made by Zahravi Pharmaceutical Co. 15 mg/week for 6 month. Intervention group 2: 16 patients, Azathioprine oral tablet (2mg/kg/day) for 6 months from Ramopharmin Pharmaceutical Co. Lichen planopilaris Activity Index. Timepoint: Measurement of Lichen planopilaris Activity Index at the beginning of the study (prior to treatment) and 2, 4, and 6 months after the treatment. Method of measurement: Using an oral questionnaire and clinical examination of patient for items in lichen planopilaris activity index. Photography. Timepoint: Photography at the beginning of the study(prior to treatment) and 2,4 and 6 month after treatment. Method of measurement: Professional camera for dermatologist. Dermoscopy. Timepoint: Dermoscopy at the beginning of the study(prior to treatment) and 2,4 and 6 month after treatment. Method of measurement: Handyscope fotofinder system. Esfahan University of Medical Sciences Approved 2020-10-29 Ethics committee of Isfahan University of Medical Sciences IsfahanUniversity of Medical Sciences,Hezarjirib street,Isfahan,Iran Isfahan Isfehan Iran (Islamic Republic of)