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

Zai Lab Pty. Ltd.6 sites in 1 country290 target enrollmentApril 26, 2017

ConditionsEczema

InterventionsZL-3101 Placebo

DrugsZL-3101 Placebo

Overview

Phase: Phase 2
Intervention: ZL-3101
Conditions: Eczema
Sponsor: Zai Lab Pty. Ltd.
Enrollment: 290
Locations: 6
Primary Endpoint: Eczema Area and Severity Index (EASI) score changes from baseline to day 21
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

April 26, 2017

End Date

September 10, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Zai Lab Pty. Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female subjects between 18 and 65 years of age inclusive, at the time of signing the informed consent; from outpatient clinic;
•Subjects with a diagnosis of subacute eczema (Zhao 2001). Subacute eczema is often developed from improperly treated acute eczema or a few with presented subacute eczema from early on-set. Subacute eczema usually presents with papule, excoriations, crusting and pruritus. Occasionally patient will present with papulovesicle, blister and erosion. Patients also need to meet the requirement of:
•Subjects must have body surface area (BSA) disease involvement between 3-10% (inclusive) as assessed by palm method;
•IGA score of 2 or 3;
•Skin lesions should be on the trunk or extremities, without palms/soles, face/scalp, and vulvar areas involved;
•Based on TCM theory (Zheng 2002), patients with TCM "damp - heat" symptoms to be included. It is subject to TCM investigator's assessment, and symptoms could be (but not limited to):
•Main symptoms: erythema, pruritus, papule with less exudation;
•Secondary symptoms: Mild infiltration, excoriations, crusting, papulovesicle, blister, irritability, thirst, yellowish urine and dry stool;
•Tongue and pulse analysis: red tongue with yellow or yellowish coating, slippery pulse model;
•Subjects are general in good health; except for eczema, there are no other health conditions that possibly interfere with the study results;

Exclusion Criteria

•The subject presents with or has the history of any systemic disorders or active skin diseases (e.g. psoriasis) that would in any way confound interpretation of the study results;
•The subject has a current complication of overt bacterial, fungal or viral infection for which treatment with anti-infective are indicated;
•Have the history of hepatic and kidney function insufficiency, hepatic dysfunction ALT or AST\>1.5 ULN, kidney function BUN, Cr\>1.5 ULN;
•QT interval corrected according to Bazett's formula or QT interval corrected according to Fridericia's formula ≥450 msec; or QTc ≥480 msec in subjects with bundle branch block;
•Have the history or examination verified by physical and screening of clinically significant cardiovascular, pulmonary, gastrointestinal, liver, renal, hematological, neurological, abnormalities and psychology disorders which will interfere with the efficacy and/or safety of the individual subject;
•History of allergy to any component of test medications to be used in the study;
•The subject has been exposed to below therapy within the set timeframe:
•Systemic administration of anti-histamine agents 1 week
•Systemic administration of corticosteroid 4 weeks;
•Topical corticosteroid agents administered in the diseased skin 1 week;