Chronic Hand Eczema
Conditions
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
Interventions
DRUGHalometasone Triclosan
Halometasone Triclosan . The study product will be applied topically twice a day (morning and evening) for 14 days of treatment
Sponsors
Beijing Friendship Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
open label
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response to Hand eczema severity | 2 weeks | HEES(hand eczema extent score) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response to treatment/Hand eczema severity | 2 weeks | Photographic evaluation |
| Investigator reported improvement | 2 weeks | IGA(investigator's global assessment) |
| Response to Quality of Life | week 0 and 2 | questionnaire :DLQI(dermatology life quality index) |
| Patient Reported Improvement | up to 2 weeks | VAS(Visual Analog Score for pruritus) |
| Response to Microbial Colonization rates | 2 weeks | Staphylococcus aureus colonization rates |
Countries
China
Outcome results
None listed