Microbial Colonization and Change of Chronic Keratinized Hand Eczema After Using Halometasone Triclosan

Study Overview
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Brief Summary
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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
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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

Official Title
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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
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Chronic Hand Eczema

Intervention / Treatment
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* Drug: Halometasone Triclosan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Halometasone Triclosan Cream<br>All subjects receive external Use of Halometasone Triclosan Cream | Drug: Halometasone Triclosan<br>* Halometasone Triclosan . The study product will be applied topically twice a day (morning and evening) for 14 days of treatment<br>* Other names: wet wrap bandage;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to Hand eczema severity | HEES(hand eczema extent score) | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to treatment/Hand eczema severity | Photographic evaluation | 2 weeks | 
| Investigator reported improvement | IGA(investigator's global assessment) | 2 weeks | 
| Response to treatment/Hand eczema severity | Dermatoscopy | 2 weeks | 
| Response to Quality of Life | questionnaire :DLQI(dermatology life quality index) | week 0 and 2 | 
| Patient Reported Improvement | VAS(Visual Analog Score for pruritus) | up to 2 weeks | 
| Response to treatment/Hand eczema severity | HECSI | 2 weeks | 
| Response to Microbial Colonization rates | Staphylococcus aureus colonization rates | 2 weeks |