Oral lichen planus (OLP) affects approximately 1.27% of the general population. Inflammatory responses constitute a major component of OLP pathogenesis where targeted therapies play an important role in managing this condition. Apremilast is a new well-tolerated and relatively safe anti-inflammatory therapy that has been approved for managing psoriasis and psoriatic arthritis. Given its safer profile, Apremilast may ameliorate inflammatory responses in clinically active OLP without the experience of serious adverse events associated with other systemic immunosuppressive therapies used to treat OLP. The plan is to conduct a single-center, explanatory, randomized, 16 weeks, parallel group, superiority, blinded, placebo-controlled, clinical trial.~The main objective is treatment success assessment. Other objectives include exploring the efficacy of Apremilast in clinically active OLP adult patients considered for systemic treatment and failed topical corticosteroid therapy. It is hypothesized that Apremilast will induce more treatment success as compared to placebo in patients who failed the standard treatment of topical corticosteroids.
Apremilast for the management of oral lichen planus.