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

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

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 Overview

• Status: Completed
• Conditions: Chronic Hand Eczema
• Intervention / Treatment: Drug: Halometasone Triclosan

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 Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100000
      • friendship Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Beijing Friendship Hospital
• Investigators: Principal Investigator: linfeng li, phd, Beijing Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2017
• Primary Completion (Actual): December 8, 2017
• Study Completion (Actual): December 8, 2017

Study Registration Dates

• First Submitted: August 2, 2017
• First Submitted That Met QC Criteria: August 8, 2017
• First Posted (Actual): August 11, 2017

Study Record Updates

• Last Update Posted (Actual): January 29, 2018
• Last Update Submitted That Met QC Criteria: January 26, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Disease Attributes; Dermatitis; Skin Diseases, Eczematous; Infections; Communicable Diseases; Eczema; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents, Local; Anti-Infective Agents; Anti-Inflammatory Agents; Antimetabolites; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dermatologic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Fatty Acid Synthesis Inhibitors; Triclosan; Halometasone
• Other Study ID Numbers: BeijingFH20170801

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No