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IRCT20241025063490N1 IRCT 2024-11-15 Shiraz University of Medical Sciences Effect of Baricitinib in Treatment of Lichen Planus Comparison of the Effectiveness of Baricitinib with Hydroxychloroquine in Improving Cutaneous Manifestations in Lichen Planus Patients 2025-01-18 anticipated 32 Complete https://irct.ir/trial/79885 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random Number Table with Blocks of Four was Made by Replacement Block Method with Random Allocation Software. Patients Codes will be Put in Dark Envelopes to Hide Random Sequence, and Patients will Enter the Trial in Order of Number. Patients,Doctor, and Resident will not Decide About the Type of Interventions and Patients will be Put in Case and Control Groups Based on Random Number Table, Blinding description: Due to Dissimilarity of Baricitinib and Hydroxychloroquine, Intervention is Unmaskable, so Blinding is not Possible for Patients.Moreover, One of the Researchers of the Trial Must not be Blind Because of the Type of Intervention to Check Complications of Case Group.so, Supervising Professor will be Care Provider and He Will not be Blinded, but Resident(Outcome Assessor, Investigator) Will not be Aware of the Type of Medicine, and Trial Will be Done as Investigator Blind Trial. 3 Lichen planus. Intervention 1: Intervention group: Tablet Baricitinib 4 mg (Arena Haiat Company) Daily for 3 months. Intervention 2: Control group: Tablet Hydroxychloroquine 200mg every 12 hours (Amin Company) for 3 months. Yes - There is a plan to make this available What will be shared: Total Data will be Shareable after Making Patient Unidentifiable ,and the Trial will be completed. When: The Start of the Access Period will be since 6 months after Publishing the Results,and it will be continued for unlimited Time Frame. To whom: Data will be available for Investigators employed in Scientific, Academic, and Industrial Institutions. Conditions: Investigator will be able to use Data for Meta-Analysis, and comparison of Different Therapeutic Methods. Where to obtain: Investigators can send Message to hoseinkargar7@gmail.com ,or 00989211230998 to access Data. Responder Name:Dr.Hossein Kargar Address:Shahid Faghihi Hospital , Near Shiraz University School of Medicine , Across the Shahid Faghihi Street , Karim Khan Zand Boulevard How to obtain: Requests for Legal Scientific, Academic, and Industrial Actions will be responded in 2 Months, and Data will be made Available for Investigators. Comments:
public Hossein Kargar
Shahid Faghihi Hospital , Near Shiraz University School of Medicine , Across the Shahid Faghihi Street , Karim Khan Zand Boulevard
Shiraz Iran (Islamic Republic of) 7134846316 +98 71 3235 1087 hosseinkargar@sums.ac.ir Shiraz University of Medical Sciences scientific Mehdi Ghahartars
Shahid Faghihi Hospital , Near Shiraz University School of Medicine , Across the Shahid Faghihi Street , Karim Khan Zand Boulevard
Shiraz Iran (Islamic Republic of) 7134846316 +98 71 3235 1087 Mghahar@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Over 16 Years Old Lichen Planus Patients Who have Cutaneous Manifestations Glomerular Filtration Rate More than 60 16 years no limit Both Pregnant Mothers Lactating Mothers Hepatic Failure Renal Failure Treated with Topical or Systemic Steroid 1 Year Before the Study Past History of Cerebrovascular Attack Past History of Myocardial Infarction Past History of Deep Vein Thrombosis Past History of Pulmonary Thromboembolism Past History of Peptic Ulcer Disease Past History of leukemia Past History of lymphoma Past History of Bone Marrow Failure Past History of G6PD Deficiency Past History of Retinopathy Past History of Neuropsychiatric Diseases Past History of lymphopenia Past History of leucopenia Patient Reluctance L43 Lichen planus Treatment - Drugs Treatment - Drugs Intervention group: Tablet Baricitinib 4 mg (Arena Haiat Company) Daily for 3 months Control group: Tablet Hydroxychloroquine 200mg every 12 hours (Amin Company) for 3 months Severity of Pruritis. Timepoint: Evaluation of Severity of Pruritis at the Beginning of the Study (before starting the Intervention) , 2,and 3 months after starting Baricitinib. Method of measurement: Numerical Visual Analogue Scale(0-10). Time it takes to Respond to Treatment. Timepoint: Evaluation of Response to Treatment at the Beginning of the Study (before starting the Intervention) , 2,and 3 months after starting Baricitinib. Method of measurement: Time it takes to Respond to Treatment ( by Weeks). Physician Global Assessment. Timepoint: Physician Global Assessment at the Beginning of the Study (before starting the Intervention) , 2,and 3 months after starting Baricitinib. Method of measurement: Physician Global Assessment Table. Lichen planus Activity and Damage Index. Timepoint: Lichen planus Activity and Damage Index at the Beginning of the Study (before starting the Intervention) , 2,and 3 months after starting Baricitinib. Method of measurement: Lichen planus Activity and Damage Index Table. Patient Satisfaction. Timepoint: Evaluation of Patient Satisfaction at the Beginning of the Study (before starting the Intervention) , 2,and 3 months after starting Baricitinib. Method of measurement: Numerical Visual Analogue Scale (0-10). Shiraz University of Medical Sciences Approved 2024-09-25 Ethics committee of Shiraz University of Medical Sciences Shahid Faghihi Hospital , Near Shiraz University School of Medicine , Across the Shahid Faghihi Street , Karim Khan Zand Boulevard Shiraz Fars Iran (Islamic Republic of)