Comparison of the Effectiveness of Baricitinib with Hydroxychloroquine in Improving Cutaneous Manifestations in Lichen Planus Patients

Comparison of Efficacy Baricitinib and Hydroxychloroquine in Cutaneous Lichen planus

Two arm parallel group randomised controlled clinical trial with blinded investigator and outcome assessment, phase 3 on 32 patients.We use Random Allocation Software for randomisation.

Control Group (16 cutaneous Lichen planus patients) will be treated with Hydroxychloroquine 200mg every 12 hours for 3 months. Intervention Group (16 cutaneous Lichen planus patients) will be treated with Baricitinib 4 mg Daily for 3 months.Clinical and laboratory evaluations will be done at the Beginning of the Study (before starting the Intervention) , 2,and 3 months after starting medicine at Shahid Faghihi Hospital.Investigator and outcome assessor will be not aware of therapeutic methods of the patients, and Trial will be investigator blind.

Inclusion Criteria:Over 16 Years Old, Lichen Planus Patients Who have Cutaneous Manifestations, Glomerular Filtration Rate More than 60 Exclusion Criteria: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

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

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.

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.

Total Data will be Shareable after Making Patient Unidentifiable ,and the Trial will be completed.

The Start of the Access Period will be since 6 months after Publishing the Results,and it will be continued for unlimited Time Frame.

Data will be available for Investigators employed in Scientific, Academic, and Industrial Institutions.

Investigator will be able to use Data for Meta-Analysis, and comparison of Different Therapeutic Methods.

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

Requests for Legal Scientific, Academic, and Industrial Actions will be responded in 2 Months, and Data will be made Available for Investigators.