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Study of Icotinib Hydrochloride Cream in Patients With Mild to Moderate Psoriasis

Brief Summary:
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

Detailed Description:
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
Allocation:Randomized
Intervention Model:Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

U.S. FDA Resources

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