Chronic Hand EczemaPhase 4MCCKNCT03246776
Microbial Colonization and Change of Chronic Keratinized Hand Eczema After Using Halometasone Triclosan
A Phase 4 study testing Halometasone Triclosan in people with Chronic Hand Eczema, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
The clinical study of the microbial colonization of chronic keratinized hand eczema and the change of microbial colonization after external using of Halometasone Triclosan Cream Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hand Eczema
- What is being tested?
- Halometasone Triclosan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2017to 8 Dec 2017
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Chronic Keratinized hand eczema for at least 3 months
- The affected area is greater than 30%
- Overall assessment of the severity of the disease(IGA)≥3 OR HEES≥13
- No obvious incentive .Who have read the instructions of the subject, agreed to and signed written informed consent, and have been able to provide a personal medical history.
Who cannot join
- Pregnancy, breast feeding
- Severe liver and kidney disease, blood system disease, autoimmune disease, chronic severe infection, diabetes, mental illness, drug use, alcohol abuse, etc
- Malignant neoplasms or other serious maladies that may affect the correct assessment of efficacy
- Topical corticosteroid was suspended for less than 2 weeks;The system used corticosteroids and other immunosuppressive agents (thunder vine and other drugs) which were suspended for less than four weeks
- Eczema of the facial and skin creases
- Atopic dermatitis, contact dermatitis, blister hand eczema, contact urticaria, discoid eczema
Show all 10Show fewer
- participated in other clinical trials within 3 months.
- Known sensitivity to Halometasone Triclosan
- failure to follow the prescribed medication or the incomplete record of the test process which will affect the curative effect judgment
- Other reasons why researchers think they should not be included
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Clinical Study of the Microbial Colonization of Chronic Keratinized Hand Eczema and the Change of Microbial Colonization After External Using of Halometasone Triclosan Cream
The clinical study of the microbial colonization of chronic keratinized hand eczema and the change of microbial colonization after external using of Halometasone Triclosan Cream
Read the detailed description
The clinical study of the microbial colonization of chronic keratinized hand eczema and the change of microbial colonization after external using of Halometasone Triclosan Cream
- Conditions
- Chronic Hand Eczema
- Being tested
- Halometasone Triclosan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Halometasone TriclosanDrug
Also called regular moisturizer, wet wrap bandage
Halometasone Triclosan . The study product will be applied topically twice a day (morning and evening) for 14 days of treatment
| Study group | Role | What they receive |
|---|---|---|
| Halometasone Triclosan Cream | Experimental | All subjects receive external Use of Halometasone Triclosan Cream Receives: Drug: Halometasone Triclosan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to Hand eczema severity
HEES(hand eczema extent score)
Measured: 2 weeks
Secondary outcomes (7)
Response to treatment/Hand eczema severity
Photographic evaluation
Measured: 2 weeks
Investigator reported improvement
IGA(investigator's global assessment)
Measured: 2 weeks
Response to treatment/Hand eczema severity
Dermatoscopy
Measured: 2 weeks
Response to Quality of Life
questionnaire :DLQI(dermatology life quality index)
Measured: week 0 and 2
Patient Reported Improvement
VAS(Visual Analog Score for pruritus)
Measured: up to 2 weeks
Response to treatment/Hand eczema severity
HECSI
Measured: 2 weeks
Response to Microbial Colonization rates
Staphylococcus aureus colonization rates
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study start20 Aug 2017
- Primary completion8 Dec 2017
- Study completion8 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hand EczemaStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Xu, Beijing Friendship Hospital
- Investigators
- linfeng li, phd, Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03246776
- Sponsor's protocol ID
- BeijingFH20170801
- Acronym
- MCCK
- Status last verified
- Jan 2018
- First submitted
- 2 Aug 2017
- Last updated
- 29 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Study of the Microbial Colonization of Chronic Keratinized Hand Eczema and the Change of Microbial Colonization After External Using of Halometasone Triclosan Cream
- ClinicalTrials.gov ID
- NCT03246776
- Acronym / sponsor ID
- MCCK / BeijingFH20170801
- Conditions
- Chronic Hand Eczema
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 20 Aug 2017 (actual)
- Primary completion
- 8 Dec 2017 (actual)
- Study completion
- 8 Dec 2017 (actual)
- First posted
- 11 Aug 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.
The clinical study of the microbial colonization of chronic keratinized hand eczema and the change of microbial colonization after external using of Halometasone Triclosan Cream
Detailed description
The clinical study of the microbial colonization of chronic keratinized hand eczema and the change of microbial colonization after external using of Halometasone Triclosan Cream
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Halometasone Triclosan Cream | Experimental | Drug: Halometasone TriclosanAll subjects receive external Use of Halometasone Triclosan Cream |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Chronic Keratinized hand eczema for at least 3 months
- The affected area is greater than 30%
- Overall assessment of the severity of the disease(IGA)≥3 OR HEES≥13
- No obvious incentive .Who have read the instructions of the subject, agreed to and signed written informed consent, and have been able to provide a personal medical history.
Key exclusion criteria (10 listed)
- Pregnancy, breast feeding
- Severe liver and kidney disease, blood system disease, autoimmune disease, chronic severe infection, diabetes, mental illness, drug use, alcohol abuse, etc
- Malignant neoplasms or other serious maladies that may affect the correct assessment of efficacy
- Topical corticosteroid was suspended for less than 2 weeks;The system used corticosteroids and other immunosuppressive agents (thunder vine and other drugs) which were suspended for less than four weeks
- Eczema of the facial and skin creases
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 |
|---|---|---|
| Halometasone TriclosanAlso: regular moisturizer, wet wrap bandageHalometasone Triclosan . The study product will be applied topically twice a day (morning and evening) for 14 days of treatment | Drug | Halometasone Triclosan Cream |
Primary outcome
Response to Hand eczema severity
Time frame: 2 weeks
HEES(hand eczema extent score)
7 secondary outcomes
Response to treatment/Hand eczema severity
Time frame: 2 weeks
Investigator reported improvement
Time frame: 2 weeks
Response to treatment/Hand eczema severity
Time frame: 2 weeks
Response to Quality of Life
Time frame: week 0 and 2
Patient Reported Improvement
Time frame: up to 2 weeks
Response to treatment/Hand eczema severity
Time frame: 2 weeks
Response to Microbial Colonization rates
Time frame: 2 weeks
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 29 Jan 2018.
- Individual participant dataSharing planned: Undecided
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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.
linfeng li, phd principal investigator
Beijing Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Halometasone Triclosan in people with Chronic Hand Eczema, run by Beijing Friendship Hospital at 1 site 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 5 inclusion and 10 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 29 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Response to Hand eczema severity (time frame: 2 weeks). 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 29 Jan 2018.