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

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ClinicalTrials.gov Identifier: NCT03246776
Recruitment Status : Completed
First Posted : August 11, 2017
Last Update Posted : January 29, 2018
Sponsor:
Information provided by (Responsible Party):
Wei Xu, Beijing Friendship Hospital

Tracking Information
First Submitted Date  ICMJE August 2, 2017
First Posted Date  ICMJE August 11, 2017
Last Update Posted Date January 29, 2018
Actual Study Start Date  ICMJE August 20, 2017
Actual Primary Completion Date December 8, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2017)
Response to Hand eczema severity [ Time Frame: 2 weeks ]
HEES(hand eczema extent score)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03246776 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2017)
  • Response to treatment/Hand eczema severity [ Time Frame: 2 weeks ]
    Photographic evaluation
  • Investigator reported improvement [ Time Frame: 2 weeks ]
    IGA(investigator's global assessment)
  • Response to treatment/Hand eczema severity [ Time Frame: 2 weeks ]
    Dermatoscopy
  • Response to Quality of Life [ Time Frame: week 0 and 2 ]
    questionnaire :DLQI(dermatology life quality index)
  • Patient Reported Improvement [ Time Frame: up to 2 weeks ]
    VAS(Visual Analog Score for pruritus)
  • Response to treatment/Hand eczema severity [ Time Frame: 2 weeks ]
    HECSI
  • Response to Microbial Colonization rates [ Time Frame: 2 weeks ]
    Staphylococcus aureus colonization rates
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Microbial Colonization and Change of Chronic Keratinized Hand Eczema After Using Halometasone Triclosan
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description:
open label
Primary Purpose: Treatment
Condition  ICMJE Chronic Hand Eczema
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Halometasone Triclosan Cream
All subjects receive external Use of Halometasone Triclosan Cream
Intervention: Drug: Halometasone Triclosan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 8, 2017)
80
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 8, 2017
Actual Primary Completion Date December 8, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03246776
Other Study ID Numbers  ICMJE BeijingFH20170801
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Wei Xu, Beijing Friendship Hospital
Study Sponsor  ICMJE Beijing Friendship Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: linfeng li, phd Beijing Friendship Hospital
PRS Account Beijing Friendship Hospital
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP