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IRCT20150825023753N31 IRCT 2026-10-30 Shiraz University of Medical Sciences Evaluation of the Effectiveness of Upadacitinib in Lichen Planus Evaluation of the Effectiveness of Upadacitinib and Hydroxychloroquine as Standard Treatment in Lichen Planus Patient 2026-10-07 anticipated 32 Recruiting https://irct.ir/trial/93576 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The patients will be divided into two groups using a permuted random blocking method of a size of 4, creating a randomization table by Random Allocation Software version ۱.۰.۰ . Moreover, dark envelopes will be used for random allocation concealment, Blinding description: Because the intervention cannot be masked (due to the dissimilarity of the drugs upadacitinib and hydroxychloroquine), blinding is not possible for the patient. Given the type of intervention, it is preferable that one of the investigators in the study be blind to assess the side effects of the case group (especially in the upadacitinib group). Therefore, the attending supervisor will be the patient's care provider and is not blind, but the investigator, outcome assessor (who does not know the type of drug the patients are taking, and the study is conducted as a blind outcome assessor). 3 lichen planus. Intervention 1: Intervention group: A group that receives the oral drug Opadacitinib Damonzia 15 mg (Kobel Daru Company) daily for 3 months. Intervention 2: Control group: This group will receive oral hydroxychloroquine (200 mg; Abidi Pharmaceutical Company, Iran) twice daily for 3 months as standard treatment for lichen planus. Yes - There is a plan to make this available What will be shared: Demographic data and the result of the clinical trial When: starting 6 months after publication To whom: The data will be accessible to researchers working at academic and scientific institutions as well as those employed in the industry Conditions: After the publication of the article based on the clinical trial, it will be possible to share the data. The recipients of the data can use the data by obtaining permission from the project managers. The managers of this project will allow the data to be used in secondary data analysis studies and systematic reviews. Where to obtain: Data requesters can submit their request by sending an email to each of the administrators that their names and emails have been entered into this system. How to obtain: Data requesters can submit their request by sending an email to each of the administrators that their names and emails have been entered into this system. Comments:
public milad falahzadeh
Dermatology Ward of Shahid Faghihi Hospital,zand street
shiraz Iran (Islamic Republic of) 7134846114 +98 71 3235 1099 miladfalahzadeh@yahoo.com Shiraz University of Medical Sciences scientific Mehdi Ghahartars
The Dermatology Department of Faghihi Hospital, Zand Street,Shiraz
shitaz Iran (Islamic Republic of) 7134846114 +98 71 3235 1099 Mghahar@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients with newly diagnosed lichen planus by a dermatologist who have not previously received any topical or systemic treatment. Patients over 16 years of age Weight more than 40 kg Glomerular filtration rate (GFR) over 60 16 years 60 years Both patients with Oral, nail, genitalia and hair involvements of lichen planus pregnant or nursing mothers evidence of renal or hepatic failure ,CVA ,MI ,DVT ,PTE ,PUD ,leukemia ,lymphoma, bone marrow failure,G۶PD deficiency ,retinopathy ,neuropsychiatric diseases ,lymphopenia , leucopenia L43 Lichen planus Treatment - Drugs Treatment - Drugs Intervention group: A group that receives the oral drug Opadacitinib Damonzia 15 mg (Kobel Daru Company) daily for 3 months. Control group: This group will receive oral hydroxychloroquine (200 mg; Abidi Pharmaceutical Company, Iran) twice daily for 3 months as standard treatment for lichen planus. Lichen Planus Activity and Damage Index. Timepoint: Before the intervention and 2 and 3 months later. Method of measurement: Lichen Planus Activity and Damage Index (LiPADI). Intensity of itching. Timepoint: At the beginning of the study and 2 and 3 months later. Method of measurement: The visual analogue scale (VAS). Patient's satisfaction. Timepoint: At the beginning of the study and 2 and 3 months later. Method of measurement: Patient global assessment (PGA). General assessment of the doctor. Timepoint: At the beginning of the study and 2 and 3 months later. Method of measurement: Physician Global Assessment (PGA). Shiraz University of Medical Sciences Approved 2026-09-06 Ethics committee of Shiraz University of Medical Sciences Shiraz University of Medical Sciences, Zand blv., Shiraz, Fars, Iran shiraz Fars Iran (Islamic Republic of)