EczemaPhase 2NCT03134352
Study to Evaluate the Efficacy and Safety of ZL-3101 in Subjects With Subacute Eczema
A Phase 2 study testing ZL-3101 in people with Eczema, run by Zai Lab Pty. Ltd. at 6 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Eczema
- What is being tested?
- ZL-3101
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 290 participants
- Where
- 6 sitesChina
- Study dates
- 26 Apr 2017to 10 Sep 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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):
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Beijing Hospital of Traditional Chinese Medicine
Beijing
Dongzhimen Hospital, Beijing University of Chinese Medicine
Beijing
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Beijing
Jiangsu Province Hospital of Traditional Chinese Medicine
Nanjing
Shanghai Dermatology Hospital
Shanghai
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of TCM
Shanghai
About this study
Official title: 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
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.
Read the 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
- Being tested
- ZL-3101, Placebo
- Keywords
- subacute
- Medical subject headings
- Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZL-3101Drug
Also called Fugan ointment
A brown ointment, 10g/tube, 0.4g herb/g ointment, Topical
PlaceboDrug
A brown ointment, 10g/tube, 0.02 g herb/g ointment (5% of Fugan active ointment), Topical
| Study group | Role | What they receive |
|---|---|---|
| ZL-3101(Fugan) bid group | Experimental | Fugan AM + Fugan PM Receives: Drug: ZL-3101 |
| ZL-3101(Fugan) qd group | Experimental | Fugan AM + Placebo PM Receives: Drug: ZL-3101; Drug: Placebo |
| placebo group | Placebo comparator | Placebo AM + Placebo PM Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start26 Apr 2017
- Primary completion25 May 2018
- Study completion10 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EczemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zai Lab Pty. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bin Li, Principal investigator, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03134352
- Sponsor's protocol ID
- ZL-3101-001
- Status last verified
- Jan 2019
- First submitted
- 25 Apr 2017
- Last updated
- 24 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03134352
- Acronym / sponsor ID
- ZL-3101-001
- Conditions
- Eczema
- Keywords
- subacute
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Zai Lab Pty. Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Apr 2017 (actual)
- Primary completion
- 25 May 2018 (actual)
- Study completion
- 10 Sep 2018 (actual)
- First posted
- 28 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ZL-3101(Fugan) bid group | Experimental | Drug: ZL-3101Fugan AM + Fugan PM |
| ZL-3101(Fugan) qd group | Experimental | Drug: ZL-3101, Drug: PlaceboFugan AM + Placebo PM |
| placebo group | Placebo comparator | Drug: PlaceboPlacebo AM + Placebo PM |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- 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):
- 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.
Key exclusion criteria (21 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZL-3101Also: Fugan ointmentA brown ointment, 10g/tube, 0.4g herb/g ointment, Topical | Drug | ZL-3101(Fugan) bid group, ZL-3101(Fugan) qd group |
| PlaceboA brown ointment, 10g/tube, 0.02 g herb/g ointment (5% of Fugan active ointment), Topical | Drug | ZL-3101(Fugan) qd group, placebo group |
Primary outcome
Eczema Area and Severity Index (EASI) score changes from baseline to day 21
Time frame: 21 days
To evaluate efficacy of Fugan ointment applied to involved skin of subjects with mild to moderate subacute eczema
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bin Li principal investigator
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ZL-3101 in people with Eczema, run by Zai Lab Pty. Ltd. at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eczema Area and Severity Index (EASI) score changes from baseline to day 21 (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2019.