Clinical trial NCT03246776: Microbial Colonization and Change of Chronic Keratinized Hand Eczema After Using Halometasone Triclosan
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Hand Eczema
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2017-08-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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

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

Eligibility criteria: 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

Primary outcomes:
measure: Response to Hand eczema severity
timeFrame: 2 weeks
Secondary outcomes:
measure: Response to treatment/Hand eczema severity
timeFrame: 2 weeks
measure: Investigator reported improvement
timeFrame: 2 weeks
measure: Response to treatment/Hand eczema severity
timeFrame: 2 weeks
measure: Response to Quality of Life
timeFrame: week 0 and 2
measure: Patient Reported Improvement
timeFrame: up to 2 weeks
measure: Response to treatment/Hand eczema severity
timeFrame: 2 weeks
measure: Response to Microbial Colonization rates
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Friendship Hospital
state: Beijing
Study officials:
affiliation: Beijing Friendship Hospital
name: linfeng li, phd
role: PRINCIPAL_INVESTIGATOR
References: