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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Eczema

Intervention / Treatment
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* Drug: ZL-3101
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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; A signed and dated written informed consent is obtained from the subject. 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; 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 The use of inhaled/intranasal steroids is permitted prior to and during the conduct of the study if already being used by the subject. The subject has a past history of alcohol or drug abuse; Pregnant women (as confirmed by a positive urine human chorionic gonadotrophin (HCG) test), women who are breast feeding, or sexually active women of child bearing potential who are not practicing an acceptable method of birth control (birth control pill, patch, implant, barrier with spermicidal jelly, IUD, etc.), as determined by the investigator. An acceptable method of birth control must be used during the entire study in sexually active women of childbearing potential. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant. Abstinence is considered as a medically acceptable form of contraception; The subject has received an investigational drug or participated in any other research trial within 30 days; Other subjects that investigator deemed as unsuitable for the trial; Subject's EASI score reaches 2 and above for lichenification and/or edema.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ZL-3101(Fugan) bid group<br>Fugan AM + Fugan PM | Drug: ZL-3101<br>* A brown ointment, 10g/tube, 0.4g herb/g ointment, Topical<br>* Other names: Fugan ointment;|
| Experimental: ZL-3101(Fugan) qd group<br>Fugan AM + Placebo PM | Drug: ZL-3101<br>* A brown ointment, 10g/tube, 0.4g herb/g ointment, Topical<br>* Other names: Fugan ointment;Drug: Placebo<br>* A brown ointment, 10g/tube, 0.02 g herb/g ointment (5% of Fugan active ointment), Topical<br>|
| Placebo Comparator: placebo group<br>Placebo AM + Placebo PM | Drug: Placebo<br>* A brown ointment, 10g/tube, 0.02 g herb/g ointment (5% of Fugan active ointment), Topical<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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subacute