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

Primary Purpose

Chronic Hand Eczema

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Halometasone Triclosan
Sponsored by
Beijing Friendship Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hand Eczema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Friendship Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Halometasone Triclosan Cream

Arm Description

All subjects receive external Use of Halometasone Triclosan Cream

Outcomes

Primary Outcome Measures

Response to Hand eczema severity
HEES(hand eczema extent score)

Secondary Outcome Measures

Response to treatment/Hand eczema severity
Photographic evaluation
Investigator reported improvement
IGA(investigator's global assessment)
Response to treatment/Hand eczema severity
Dermatoscopy
Response to Quality of Life
questionnaire :DLQI(dermatology life quality index)
Patient Reported Improvement
VAS(Visual Analog Score for pruritus)
Response to treatment/Hand eczema severity
HECSI
Response to Microbial Colonization rates
Staphylococcus aureus colonization rates

Full Information

First Posted
August 2, 2017
Last Updated
January 26, 2018
Sponsor
Beijing Friendship Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03246776
Brief Title
Microbial Colonization and Change of Chronic Keratinized Hand Eczema After Using Halometasone Triclosan
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
August 20, 2017 (Actual)
Primary Completion Date
December 8, 2017 (Actual)
Study Completion Date
December 8, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Friendship Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hand Eczema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
open label
Allocation
N/A
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Halometasone Triclosan Cream
Arm Type
Experimental
Arm Description
All subjects receive external Use of Halometasone Triclosan Cream
Intervention Type
Drug
Intervention Name(s)
Halometasone Triclosan
Other Intervention Name(s)
regular moisturizer, wet wrap bandage
Intervention Description
Halometasone Triclosan . The study product will be applied topically twice a day (morning and evening) for 14 days of treatment
Primary Outcome Measure Information:
Title
Response to Hand eczema severity
Description
HEES(hand eczema extent score)
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Response to treatment/Hand eczema severity
Description
Photographic evaluation
Time Frame
2 weeks
Title
Investigator reported improvement
Description
IGA(investigator's global assessment)
Time Frame
2 weeks
Title
Response to treatment/Hand eczema severity
Description
Dermatoscopy
Time Frame
2 weeks
Title
Response to Quality of Life
Description
questionnaire :DLQI(dermatology life quality index)
Time Frame
week 0 and 2
Title
Patient Reported Improvement
Description
VAS(Visual Analog Score for pruritus)
Time Frame
up to 2 weeks
Title
Response to treatment/Hand eczema severity
Description
HECSI
Time Frame
2 weeks
Title
Response to Microbial Colonization rates
Description
Staphylococcus aureus colonization rates
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
linfeng li, phd
Organizational Affiliation
Beijing Friendship Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Friendship Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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