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

NCT03246776 — Phase 4, Completed, 80 participants, Beijing Friendship Hospital

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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

RegistryNCT03246776, acronym MCCK
StatusCompleted
PhasePhase 4
Study typeInterventional; na, single group, masking: none, treatment
Enrollment80 (Actual)
SponsorBeijing Friendship Hospital (Other)
ConditionsChronic Hand Eczema
InterventionsHalometasone Triclosan (Drug)
Datesstart 2017-08-20, primary completion 2017-12-08, completion 2017-12-08, first posted 2017-08-11, last updated 2018-01-29
Locations1 site in China

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-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

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+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

+Arms and interventions

ArmTypeInterventionsDescription
Halometasone Triclosan CreamExperimentalDrug: Halometasone TriclosanAll subjects receive external Use of Halometasone Triclosan Cream
  • Halometasone Triclosan (Drug), also known as regular moisturizer, wet wrap bandage: Halometasone Triclosan . The study product will be applied topically twice a day (morning and evening) for 14 days of treatment

+Outcome measures

Primary outcomes

  • Response to Hand eczema severity [2 weeks]: HEES(hand eczema extent score)

Secondary outcomes

  • Response to treatment/Hand eczema severity [2 weeks]: Photographic evaluation
  • Investigator reported improvement [2 weeks]: IGA(investigator's global assessment)
  • Response to treatment/Hand eczema severity [2 weeks]: Dermatoscopy
  • Response to Quality of Life [week 0 and 2]: questionnaire :DLQI(dermatology life quality index)
  • Patient Reported Improvement [up to 2 weeks]: VAS(Visual Analog Score for pruritus)
  • Response to treatment/Hand eczema severity [2 weeks]: HECSI
  • Response to Microbial Colonization rates [2 weeks]: Staphylococcus aureus colonization rates

+Eligibility

Sex: All, ages: 18 Years to any

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

+Locations (1)

FacilityCityCountryStatus
Friendship HospitalBeijing, Beijing MunicipalityChina

+Investigators

  • linfeng li, phd, Principal investigator, Beijing Friendship Hospital

My Notes