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

Chronic Hand Eczema Clinical Trial

— MCCK  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03246776
• Other study ID #: BeijingFH20170801
• Status: Completed
• Phase: Phase 4
• First received: August 2, 2017
• Last updated: January 26, 2018
• Start date: August 20, 2017
• Est. completion date: December 8, 2017

Study information

• Verified date: January 2018
• Source: Beijing Friendship Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 8, 2017
• Est. primary completion date: December 8, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Hand Eczema
• Communicable Diseases
• Eczema
• Infection

Intervention

Drug:
• Halometasone Triclosan
Halometasone Triclosan . The study product will be applied topically twice a day (morning and evening) for 14 days of treatment

Locations

Country	Name	City	State
China	Friendship Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

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