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

NCT03134352 | Completed Phase 2

• 1 other identifier: ZL-3101-001
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 6

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.

Conditions

Eczema

Keywords

subacute

Outcome Measures

Primary Outcomes (1)

• Eczema Area and Severity Index (EASI) score changes from baseline to day 21

  To evaluate efficacy of Fugan ointment applied to involved skin of subjects with mild to moderate subacute eczema

  21 days

Study Arms (3)

ZL-3101(Fugan) bid group

EXPERIMENTAL

Fugan AM + Fugan PM

Drug: ZL-3101

ZL-3101(Fugan) qd group

EXPERIMENTAL

Fugan AM + Placebo PM

Drug: ZL-3101; Drug: Placebo

placebo group

PLACEBO COMPARATOR

Placebo AM + Placebo PM

Drug: Placebo

Interventions

ZL-3101 DRUG

A brown ointment, 10g/tube, 0.4g herb/g ointment, Topical

Also known as: Fugan ointment

ZL-3101(Fugan) bid group; ZL-3101(Fugan) qd group

Placebo DRUG

A brown ointment, 10g/tube, 0.02 g herb/g ointment (5% of Fugan active ointment), Topical

ZL-3101(Fugan) qd group; placebo group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• A signed and dated written informed consent is obtained from the subject.

You may not qualify if:

• 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;
• Systemic administration of immunosuppressive drugs 4 weeks;
• Topical immunosuppressive drugs administered in the diseased skin 1 week;
• Systemic administration of any TCM drugs 2 weeks;
• Topical administration of any TCM drugs 1 week;
• UV therapy 4 weeks

Sponsors & Collaborators

• Zai Lab Pty. Ltd.: lead

Study Sites (6)

Beijing Hospital of Traditional Chinese Medicine

Beijing, China

Location

Dongzhimen Hospital, Beijing University of Chinese Medicine

Beijing, China

Location

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

Beijing, China

Location

Jiangsu Province Hospital of Traditional Chinese Medicine

Nanjing, China

Location

Shanghai Dermatology Hospital

Shanghai, China

Location

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of TCM

Shanghai, China

Location

MeSH Terms

Conditions

Eczema

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Study Officials

• Bin Li

  Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of TCM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2017
• First Posted: April 28, 2017
• Study Start: April 26, 2017
• Primary Completion: May 25, 2018
• Study Completion: September 10, 2018
• Last Updated: January 24, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)