]>
IRCT20190325043107N86 IRCT 2026-09-19 Tabriz University of Medical Sciences Comparison of the Efficacy of Tofacitinib and Mycophenolate Mofetil in the Treatment of Lichen Planopilaris Comparison of the Efficacy of Tofacitinib and Mycophenolate Mofetil in the Treatment of Lichen Planopilaris 2026-10-06 anticipated 30 Recruiting https://irct.ir/trial/93428 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, with a sample size of 75, participants will be assigned to three groups using permuted block randomization. A block size of four will be employed, utilizing all possible combinations, including: Block 1 (BBAA), Block 2 (AABB), Block 3 (ABAB), Block 4 (BABA), Block 5 (ABBA), and Block 6 (BAAB). To accommodate 75 participants, 19 blocks will be generated using Random Allocation Software, with blocks randomly selected from numbers 1 to 6. For instance, if block 6 and block 2 are selected sequentially, the allocation sequence will be BAABAABB, assigning individuals to Intervention Group (A) Control Group (B). To ensure allocation concealment, the randomization list will be prepared and numbered by an independent researcher who is not involved in patient recruitment or assessment. The assignments will be placed in sequentially numbered, opaque, sealed envelopes (SNOSE). The study investigator will open the envelopes in numerical order only after a patient has been formally enrolled and their code has been recorded, ensuring that the allocation sequence remains unpredictable, Blinding description: In this study, to ensure proper patient blinding, the medications for groups A and B will be prepared in identical appearance, color, packaging, and administration method, making them indistinguishable to participants. Each medication will be labeled with a unique code (A or B), known only to an independent researcher who is not involved in patient recruitment or evaluation. The envelopes containing the coded medication will be provided to the study investigator in sequential order, without any indication of treatment type. Consequently, both patients and the investigator will remain unaware of group allocation, thus maintaining a practical and effective double‑blind design throughout the trial. 2-3 Lichen Planopilaris Activity Index. Intervention 1: Intervention group: This group will receive 5 mg of Tofacitinib orally on a daily basis. The efficacy of this treatment will be assessed at predefined time points using the Lichen Planopilaris Activity Index (LPPAI), which quantifies clinical symptom changes (such as pruritus and pain) and physical examination findings. Intervention 2: Control group: This group will receive 2 g of oral Mycophenolate Mofetil daily. Similar to the first group, treatment response will be monitored at scheduled intervals using the Lichen Planopilaris Activity Index (LPPAI) to accurately measure the improvement of clinical symptoms and physical examination findings. 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 further information available.
public Mehdi Khanbabayi Gol
Imam Reza Hospital, Azadi Ave
Tabriz Iran (Islamic Republic of) 5165665631 +98 41 3334 7054 Khanbabayimehdi69@gmail.com Tabriz University of Medical Sciences scientific Faegheh Sheykhalizadeh Nobar
Imam Reza Hospital, Azadi Ave
Tabriz Iran (Islamic Republic of) 5165665631 +98 41 3335 7310 faeghekhsykh@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Age between 18 and 65 years Definitive diagnosis of LPP based on clinical findings and biopsy 18 years 65 years Both Pregnancy or lactation History of severe autoimmune, hepatic, or renal diseases L66.1 Lichen planopilaris Treatment - Drugs Treatment - Drugs Intervention group: This group will receive 5 mg of Tofacitinib orally on a daily basis. The efficacy of this treatment will be assessed at predefined time points using the Lichen Planopilaris Activity Index (LPPAI), which quantifies clinical symptom changes (such as pruritus and pain) and physical examination findings. Control group: This group will receive 2 g of oral Mycophenolate Mofetil daily. Similar to the first group, treatment response will be monitored at scheduled intervals using the Lichen Planopilaris Activity Index (LPPAI) to accurately measure the improvement of clinical symptoms and physical examination findings. Lichen Planopilaris Activity Index. Timepoint: Patients will be assessed at two time points: at baseline (before the intervention) and 3 months post-intervention. Method of measurement: Lichen Planopilaris Activity Index. Tabriz University of Medical Sciences Approved 2026-08-09 Ethics committee of Tabriz University of Medical Sciences Imam Reza Hospital, Azadi Ave Tabriz East Azarbaijan Iran (Islamic Republic of)