NCT02801435

Icotinib Hydrochloride Cream in Patients With Mild to Moderate Psoriasis

A Single-Center, Randomized, Double-blind, Placebo-Controlled Study to Evaluate Safety, Tolerability and Pharmacokinetics of Icotinib Hydrochloride Cream in Patients With Mild to Moderate Psoriasis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Betta Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Icotinib Hydrochloride is a small-molecule epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, which has been approved for the treatment of advanced nonsmall- 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, doubleblind, placebo-controlled study of 0.5%, 1.0%, 2.0%, 4.0% icotinib hydrochloride cream by topical administration. Icotinib hydrochloride cream will be applied to subjects with mild to moderate psoriasis. Approximately 40 subjects will be enrolled.

Conditions

• Psoriasis

Interventions

Type	Name	Description
DRUG	0.5% Icotinib hydrochloride cream	Topical administration for twice daily
DRUG	1.0% Icotinib hydrochloride cream	Topical administration for twice daily
DRUG	2.0% Icotinib hydrochloride cream	Topical administration for twice daily
DRUG	4.0% Icotinib hydrochloride cream	Topical administration for twice daily
DRUG	Placebo	Topical administration for twice daily

Timeline

• Start date: 2016-09-17
• Primary completion: 2017-06-08
• Completion: 2017-06-08
• First posted: 2016-06-15
• Last updated: 2017-07-17

Locations

1 site across 1 country: China