NCT03134352

Study to Evaluate the Efficacy and Safety of ZL-3101 in Subjects With Subacute Eczema

A Multi-center, Randomized, Double-blind, Parallel, Placebo Controlled Phase II Study to Evaluate the Efficacy and Safety of Fugan Ointment (ZL-3101) in Subjects With Subacute Eczema

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 290 (actual)
• Sponsor: Zai Lab Pty. Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a double-blind, randomized, placebo-controlled multi-center phase IIA study to evaluate the clinical efficacy and safety of Fugan ointment versus placebo applied to involved skin of subjects with mild to moderate subacute eczema.

Detailed description

In this study, patients will be recruited and randomized in a ratio of 2:2:1 into Fugan bid group (Fugan AM + Fugan PM), Fugan qd group (Fugan AM + Placebo PM), and placebo group (Placebo AM + Placebo PM). Randomization will be stratified by disease severity (mild IGA=2 vs. moderate IGA=3). The patients will be given 3-week treatment and followed up for two weeks after the treatment. Screening period is set as 1 week. Subjects will be given 3-week treatment and followed up for two weeks after the treatment. Approximately 310 subjects will be randomized to achieve 250 evaluable subjects completing the study.

Conditions

• Eczema

Interventions

Type	Name	Description
DRUG	ZL-3101	A brown ointment, 10g/tube, 0.4g herb/g ointment, Topical
DRUG	Placebo	A brown ointment, 10g/tube, 0.02 g herb/g ointment (5% of Fugan active ointment), Topical

Timeline

• Start date: 2017-04-26
• Primary completion: 2018-05-25
• Completion: 2018-09-10
• First posted: 2017-04-28
• Last updated: 2019-01-24

Locations

6 sites across 1 country: China