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Completed

NCT Number: NCT03246776

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

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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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Friendship Hospital

Beijing, Beijing Municipality, 100000, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Halometasone Triclosan

Drug

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 outcomes

  1. Response to Hand eczema severity

    Time frame: 2 weeks

    HEES(hand eczema extent score)

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Beijing Friendship Hospital

Other

Registry information

Official study 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

Acronym: MCCK

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 11, 2017
Registry last updated
Jan 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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