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

Phase 4

Completed

• Conditions: Chronic Hand Eczema
• Interventions: Drug: Halometasone Triclosan

• Registration Number: NCT03246776
• Lead Sponsor: Beijing Friendship Hospital

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

Study Timeline

• Study First Submitted: 2017-08-02
• Study First Submitted QC: 2017-08-08
• Study First Posted: 2017-08-11
• Study Start: 2017-08-20
• Primary Completion: 2017-12-08
• Study Completion: 2017-12-08
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-26
• Last Update Posted: 2018-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Halometasone Triclosan Cream	Halometasone Triclosan	All subjects receive external Use of Halometasone Triclosan Cream

Primary Outcome Measures

Name	Time	Method
Response to Hand eczema severity	2 weeks	HEES(hand eczema extent score)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Friendship Hospital; 🇨🇳 Beijing, Beijing, China