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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

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

Condition or disease Intervention/treatment Phase
Chronic Hand Eczema Drug: Halometasone Triclosan Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: open label
Primary Purpose: Treatment
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
Actual Study Start Date : August 20, 2017
Actual Primary Completion Date : December 8, 2017
Actual Study Completion Date : December 8, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
Drug Information available for: Triclosan

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




Primary Outcome Measures :
  1. Response to Hand eczema severity [ Time Frame: 2 weeks ]
    HEES(hand eczema extent score)


Secondary Outcome Measures :
  1. Response to treatment/Hand eczema severity [ Time Frame: 2 weeks ]
    Photographic evaluation

  2. Investigator reported improvement [ Time Frame: 2 weeks ]
    IGA(investigator's global assessment)

  3. Response to treatment/Hand eczema severity [ Time Frame: 2 weeks ]
    Dermatoscopy

  4. Response to Quality of Life [ Time Frame: week 0 and 2 ]
    questionnaire :DLQI(dermatology life quality index)

  5. Patient Reported Improvement [ Time Frame: up to 2 weeks ]
    VAS(Visual Analog Score for pruritus)

  6. Response to treatment/Hand eczema severity [ Time Frame: 2 weeks ]
    HECSI

  7. Response to Microbial Colonization rates [ Time Frame: 2 weeks ]
    Staphylococcus aureus colonization rates



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03246776


Locations
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China, Beijing
Friendship Hospital
Beijing, Beijing, China, 100000
Sponsors and Collaborators
Beijing Friendship Hospital
Investigators
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Principal Investigator: linfeng li, phd Beijing Friendship Hospital

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Responsible Party: Wei Xu, associated professor, Beijing Friendship Hospital
ClinicalTrials.gov Identifier: NCT03246776     History of Changes
Other Study ID Numbers: BeijingFH20170801
First Posted: August 11, 2017    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Additional relevant MeSH terms:
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Eczema
Communicable Diseases
Infection
Dermatitis
Skin Diseases
Skin Diseases, Eczematous
Triclosan
Halometasone
Betamethasone
Anti-Infective Agents, Local
Anti-Infective Agents
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Anti-Inflammatory Agents
Dermatologic Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents