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

This study will be conducted at Sina Hospital in Tabriz. Patients will be randomly assigned to two groups: the first group (n=15) will receive 5 mg of tofacitinib daily, and the second group (n=15) will receive oral mycophenolate mofetil at a daily dose of 2 g. The treatment duration will be 6 months, and patient response to treatment will be assessed at months 0 (baseline), 2, 4, and 6 using the Lichen Planopilaris Activity Index (LPPAI).

This study is a randomized clinical trial conducted at the Sina Educational-Treatment Center in Tabriz. Following the assessment of inclusion and exclusion criteria, participants will be randomly allocated into two intervention groups. The first group will receive Tofacitinib (5 mg daily), and the second group will receive oral Mycophenolate Mofetil (2 g daily). The treatment duration is 6 months, and the response to treatment will be assessed at months 0 (baseline), 2, 4, and 6 using the Lichen Planopilaris Activity Index (LPPAI) by the investigators.

Inclusion criteria: Age between 18 and 65 years Definitive diagnosis of LPP based on clinical findings and biopsy Exclusion criteria: Pregnancy or lactation History of severe autoimmune, hepatic, or renal diseases

This study will be conducted at Sina Hospital in Tabriz. The first group (n=15) will receive 5 mg of tofacitinib daily, and the second group (n=15) will receive oral mycophenolate mofetil at a daily dose of 2 g. The treatment duration will be 6 months, and patients will be assessed at months 0 (baseline), 2, 4, and 6 using the Lichen Planopilaris Activity Index (LPPAI).

Disease severity

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.

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.