Efficacy and Safety of Benvitimod Cream in Cutaneous T-Cell Lymphoma

Background:CTCL is a rare type of non‐Hodgkin lymphoma that primarily affects the skin, causing redpatches, plaques, and severe itching. Currently, topical corticosteroids are commonlyused for early‐stage disease, but long‐term application can cause significant skin sideeffects such as atrophy. Benvitimod is a novel, non‐steroidal aryl hydrocarbon receptor(AhR) agonist. Previous studies suggest it has the potential to inhibit tumor cellproliferation and reduce skin inflammation, providing a promising new targeted therapyfor CTCL patients.Study Design:This is a prospective, single‐center, double‐blind, placebo‐controlled study. To ensure ahighly accurate comparison and eliminate individual differences, the study uses anintra‐patient (left‐right) control design. Approximately 35 patients will be enrolled.Participants will have two comparable target lesions selected on opposite sides of theirbody (e.g., left and right trunk or limbs). They will be randomly assigned to applybenvitimod cream to the lesion on one side and a placebo cream to the matching lesion onthe other side. The creams will be applied once daily for up to 24 weeks.Researchers will evaluate the improvement in skin lesions (using the mSWAT score),reduction in itching (using the VAS score), and closely monitor any adverse events atweeks 2, 4, 8, 16, and 24 to assess both the effectiveness and safety of the treatment.