Oral Lichen Planus Clinical Trial
Official title:
The APOLP Trial: A Single-Center, Randomized, 16 Weeks, Explanatory, Parallel-Group, Superiority, Blinded, Placebo-Controlled, Clinical Trial of Apremilast Use in Oral Lichen Planus
Apremilast for the management of oral lichen planus.
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
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