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Icotinib Hydrochloride Cream in Healthy Adults and Psoriasis Patients

Psoriasis Clinical Trial

Official title:
A Single-Center, Randomized, Double-blind, Placebo-Controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of Icotinib Hydrochloride Cream in Healthy Adult Participants, Followed by Patients With Mild to Moderate Psoriasis

Clinical Trial Summary

This is a phase I study to evaluate the safety, tolerability and pharmacokinetics of Icotinib Hydrochloride Cream in healthy adults and patients with mild to moderate psoriasis.

Clinical Trial Description

Icotinib Hydrochloride is a small-molecule epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, which has been approved for the treatment of advanced non-small-cell lung cancer (NSCLC) in China in its oral form. As EGFR is implicated in the pathogenesis of psoriasis, icotinib hydrochloride is being developed as a cream for the treatment of mild to moderate psoriasis. This is a single-center, randomized, double-blind, placebo-controlled study of icotinib hydrochloride cream by topical administration. The study is designed in two parts in healthy subjects (part 1) followed by patients with mild to moderate psoriasis (part 2). 1% and 2% icotinib hydrochloride cream will be initially applied to healthy subjects. Once the study in healthy adults shows favorable safety and tolerability, a study in patients with mild to moderate psoriasis will be followed. Approximately 28 subjects will be enrolled, including 12 healthy subjects (Part 1) and 16 patients with psoriasis (Part 2). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02574091
Study type Interventional
Source Betta Pharmaceuticals Co.,Ltd.
Contact
Status Completed
Phase Phase 1
Start date November 26, 2015
Completion date February 19, 2017
View Details
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