EczemaPhase 2NCT02517957
Xia Shi Surgical Treatment for Eczema Multi-center Clinical Research
A Phase 2 study testing Furoic acid loperamide hydrochloride cream, Mullite ointment and 3% boric acid solution in people with Eczema, run by Shanghai Yueyang Integrated Medicine Hospital.
Trial summary
On the basis of Xiashi skin surgery clinical experience, this project adopts the multicenter, randomized, double-blind, controlled trial of design type. Objective, normative evaluation of traditional Chinese medicine cool blood latent town effectiveness of therapeutic regimen in the treatment of eczema, security, and… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Eczema
- What is being tested?
- Furoic acid loperamide hydrochloride cream, Mullite ointment and 3% boric acid solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 342 participants
- Where
- No sites listed yet
- Study dates
- Aug 2015to Aug 2017
- 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
- accord with standard of syndrome differentiation of traditional Chinese medicine (blood hot sheng) and western medicine diagnostic criteria (subacute eczema);
- age between 18-65 years old, gender, ethnic unlimited;
- agreed to participate in clinical trials can observe and cooperate with the visitor on schedule;
- volunteered for this study and obtain informed consent will be;
- lesion area of about 5-30% of surface area (BSA) were (containing 3% and 3%, palm measurement method)
- IGA scale of 1 to 3 points (including);
- her lesions mainly located in the trunk and limbs (or);
- Women HCG negative;
Who cannot join
- known to the study of drug allergy to any of the components;
- previous or current with any may affect the results of systemic disease, or other activity of skin diseases (such as: psoriasis);
- has a liver and kidney function is not complete, liver damage of ALT and AST > 1.5 times the upper limit of normal, renal BUN > 1.5 times the upper limit of normal or creatinine > 1.5 times the upper limit of normal value;
- QTcB or QTcF acuity 450 milliseconds. For subjects QTc acuity bundle branch block 480 milliseconds.
- prior or current with clinical significance of cardiovascular, lung disease, gastrointestinal tract, liver, kidney, blood, nerve abnormalities or mental disease;
- breast-feeding or plan to pregnant women during test;
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- skin area score > 30%;
- eosinophil count score > 10%
- for nearly two weeks taking corticosteroids or a week, both inside and outside with corticosteroid preparation;
- three months received study medication or other participated in other clinical subjects;
- for any reason cannot cooperate research, for example: how language understanding, not to research centers, etc.;
- Researchers believe can bring obvious risk patients or confuse the results of the study, which should rule out other conditions or disease.
Trial locations and contacts
No sites are listed yet.
About this study
On the basis of Xiashi skin surgery clinical experience, this project adopts the multicenter, randomized, double-blind, controlled trial of design type. Objective, normative evaluation of traditional Chinese medicine cool blood latent town effectiveness of therapeutic regimen in the treatment of eczema, security, and control of the relapse of situation, provide high-level evidence-based basis for traditional Chinese medicine treatment of eczema, aims to form suitable for popularization and application of traditional Chinese medicine in the treatment of eczema.
- Conditions
- Eczema
- Being tested
- Furoic acid loperamide hydrochloride cream, Mullite ointment, 3% boric acid solution, Zine oxide
- Keywords
- Xiashi surgical
- Medical subject headings
- Eczema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Furoic acid loperamide hydrochloride creamDrug
Apply to lesion area without erosion, drainage, 1 times a day, continuous use 1 week after according to disease reduction or withdrawal, the longest do not exceed 4 weeks. Pure dry area or no skin itching area should not be applied.
Mullite ointmentDrug
Applies to a blister, pustule, erosion, ulcer, leaking or comorbid folliculitis, in skin lesions of 2 times a day, 5 days for one period of treatment, but for two consecutive period of treatment
3% boric acid solutionDrug
3% boric acid solution is suitable for the erosion seepage skin, can open intermittent shi fu, 5-10 min each time, 2 times daily or several times.
Zine oxideDrug
In wet apply the break to zinc oxide preparation for external use only, when erosion seepage control is disabled in skin lesions.
| Study group | Role | What they receive |
|---|---|---|
| Qinzhuliangxue Keli | Experimental | Qinzhuliangxue Keli(common name: QZLX particles, shenzhen China resources san-jiu pharmaceutical trading co., LTD.), loratadine tablets placebo (common name: LLTD piece, Shanghai schering pharmaceutical co., LTD.) Receives: Drug: Furoic acid loperamide hydrochloride cream; Drug: Mullite ointment; Drug: 3% boric acid solution; Drug: Zine oxide |
| loratadine tablets | Active comparator | Qinzhuliangxue Keli placebo (common name: QZLX particles, shenzhen China resources san-jiu pharmaceutical trading co., LTD.),Loratadine tablets (common name: LLTD piece, Shanghai schering pharmaceutical co., LTD.). Receives: Drug: Furoic acid loperamide hydrochloride cream; Drug: Mullite ointment; Drug: 3% boric acid solution; Drug: Zine oxide |
| Qinzhuliangxue and loratadine | Active comparator | Qinzhuliangxue Keli (common name: QZLX particles, shenzhen China resources san-jiu pharmaceutical trading co., LTD.), loratadine tablets (common name: LLTD piece, Shanghai schering pharmaceutical co., LTD.). Receives: Drug: Furoic acid loperamide hydrochloride cream; Drug: Mullite ointment; Drug: 3% boric acid solution; Drug: Zine oxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the Eczema Area and Severity Index (EASI) score
Measured: Baseline and up to week 4 of the follow up phase
Secondary outcomes (2)
Dermatology life quality index (DLQI)
Measured: Baseline and up to week 4 of the follow up phase
Change in Itching degree score
Measured: Baseline and up to week 4 of the follow up phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2017 (estimated)
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
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 342 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Yueyang Integrated Medicine Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02517957
- Sponsor's protocol ID
- 14401970200
- Status last verified
- Aug 2015
- First submitted
- 5 Aug 2015
- Last updated
- 7 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xia Shi Surgical Treatment for Eczema Multi-center Clinical Research
- ClinicalTrials.gov ID
- NCT02517957
- Acronym / sponsor ID
- 14401970200
- Conditions
- Eczema
- Keywords
- Xiashi surgical
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 342 participants (estimated)
- Lead sponsor
- Shanghai Yueyang Integrated Medicine HospitalUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Aug 2017 (estimated)
- First posted
- 7 Aug 2015 (estimated)
- 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.
On the basis of Xiashi skin surgery clinical experience, this project adopts the multicenter, randomized, double-blind, controlled trial of design type. Objective, normative evaluation of traditional Chinese medicine cool blood latent town effectiveness of therapeutic regimen in the treatment of eczema, security, and control of the relapse of situation, provide high-level evidence-based basis for traditional Chinese medicine treatment of eczema, aims to form suitable for popularization and application of traditional Chinese medicine in the treatment of eczema.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Qinzhuliangxue Keli | Experimental | Drug: Furoic acid loperamide hydrochloride cream, Drug: Mullite ointment, Drug: 3% boric acid solution, Drug: Zine oxideQinzhuliangxue Keli(common name: QZLX particles, shenzhen China resources san-jiu pharmaceutical trading co., LTD.), loratadine tablets placebo (common name: LLTD piece, Shanghai schering pharmaceutical co., LTD.) |
| loratadine tablets | Active comparator | Drug: Furoic acid loperamide hydrochloride cream, Drug: Mullite ointment, Drug: 3% boric acid solution, Drug: Zine oxideQinzhuliangxue Keli placebo (common name: QZLX particles, shenzhen China resources san-jiu pharmaceutical trading co., LTD.),Loratadine tablets (common name: LLTD piece, Shanghai schering pharmaceutical co., LTD.). |
| Qinzhuliangxue and loratadine | Active comparator | Drug: Furoic acid loperamide hydrochloride cream, Drug: Mullite ointment, Drug: 3% boric acid solution, Drug: Zine oxideQinzhuliangxue Keli (common name: QZLX particles, shenzhen China resources san-jiu pharmaceutical trading co., LTD.), loratadine tablets (common name: LLTD piece, Shanghai schering pharmaceutical co., LTD.). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- accord with standard of syndrome differentiation of traditional Chinese medicine (blood hot sheng) and western medicine diagnostic criteria (subacute eczema);
- age between 18-65 years old, gender, ethnic unlimited;
- agreed to participate in clinical trials can observe and cooperate with the visitor on schedule;
- volunteered for this study and obtain informed consent will be;
- lesion area of about 5-30% of surface area (BSA) were (containing 3% and 3%, palm measurement method)
Key exclusion criteria (12 listed)
- known to the study of drug allergy to any of the components;
- previous or current with any may affect the results of systemic disease, or other activity of skin diseases (such as: psoriasis);
- has a liver and kidney function is not complete, liver damage of ALT and AST > 1.5 times the upper limit of normal, renal BUN > 1.5 times the upper limit of normal or creatinine > 1.5 times the upper limit of normal value;
- QTcB or QTcF acuity 450 milliseconds. For subjects QTc acuity bundle branch block 480 milliseconds.
- prior or current with clinical significance of cardiovascular, lung disease, gastrointestinal tract, liver, kidney, blood, nerve abnormalities or mental disease;
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 |
|---|---|---|
| Furoic acid loperamide hydrochloride creamApply to lesion area without erosion, drainage, 1 times a day, continuous use 1 week after according to disease reduction or withdrawal, the longest do not exceed 4 weeks. Pure dry area or no skin itching area should not be applied. | Drug | Qinzhuliangxue Keli, Qinzhuliangxue and loratadine, loratadine tablets |
| Mullite ointmentApplies to a blister, pustule, erosion, ulcer, leaking or comorbid folliculitis, in skin lesions of 2 times a day, 5 days for one period of treatment, but for two consecutive period of treatment | Drug | Qinzhuliangxue Keli, Qinzhuliangxue and loratadine, loratadine tablets |
| 3% boric acid solution3% boric acid solution is suitable for the erosion seepage skin, can open intermittent shi fu, 5-10 min each time, 2 times daily or several times. | Drug | Qinzhuliangxue Keli, Qinzhuliangxue and loratadine, loratadine tablets |
| Zine oxideIn wet apply the break to zinc oxide preparation for external use only, when erosion seepage control is disabled in skin lesions. | Drug | Qinzhuliangxue Keli, Qinzhuliangxue and loratadine, loratadine tablets |
Primary outcome
Change from Baseline in the Eczema Area and Severity Index (EASI) score
Time frame: Baseline and up to week 4 of the follow up phase
2 secondary outcomes
Dermatology life quality index (DLQI)
Time frame: Baseline and up to week 4 of the follow up phase
Change in Itching degree score
Time frame: Baseline and up to week 4 of the follow up phase
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2015.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Furoic acid loperamide hydrochloride cream, Mullite ointment and 3% boric acid solution in people with Eczema, run by Shanghai Yueyang Integrated Medicine Hospital.
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 8 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 7 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Bin, director (0086-021-65162629, 18930568129@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the Eczema Area and Severity Index (EASI) score (time frame: Baseline and up to week 4 of the follow up phase). 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 7 Aug 2015.