This is a phase II study to evaluate the efficacy and safety of Icotinib Hydrochloride Cream in patients with mild to moderate psoriasis.
|Condition or disease||Intervention/treatment||Phase|
|Mild to Moderate Psoriasis||Drug: Icotinib hydrochloride cream Drug: Placebo cream||Phase 2|
Icotinib Hydrochloride is an oral, small-molecule epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, which has been approved for treating advanced non-small cell lung cancer (NSCLC) in China. Over-expressions of EGFR and its downstream signaling proteins are implicated in the pathogenesis of psoriasis and TKIs have been considered as potential antipsoriatic agents. Icotinib hydrochloride is being developed as a cream for the treatment of mild to moderate psoriasis. This is a multicenter , randomized, doubleblind, four-arm parallel-group, placebo-controlled phase II study to assess the efficacy and safety of icotinib hydrochloride cream (1.0%, 2.0%, 4.0%) in patients with mild to moderate psoriasis. Approximately 260 subjects will be enrolled.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||260 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Multicenter, Randomized, Double-blind, Four-Arm Parallel-Group, Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of Icotinib Hydrochloride Cream in Patients With Mild to Moderate Psoriasis|
|Actual Study Start Date :||November 29, 2017|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||December 2018|