Microbial Colonization and Change of Chronic Keratinized... | NCT03246776

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

NCT03246776

Sponsor

Beijing Friendship Hospital

Status

Completed

Last Update Posted

Jan 29, 2018Actual

Enrollment

80Actual

Phase

Phase 4

Conditions

Chronic Hand Eczema

Interventions

Halometasone Triclosan

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 20, 2017Actual

Primary Completion Date

Dec 8, 2017Actual

Completion Date

Dec 8, 2017Actual

First Submitted Date

Aug 2, 2017

First Submission Date that Met QC Criteria

Aug 8, 2017

First Posted Date

Aug 11, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 26, 2018

Last Update Posted Date

Jan 29, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Halometasone Triclosan Cream	Experimental	All subjects receive external Use of Halometasone Triclosan Cream	Drug: Halometasone Triclosan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Halometasone Triclosan	Drug	Halometasone Triclosan . The study product will be applied topically twice a day (morning and evening) for 14 days of treatment	Halometasone Triclosan Cream

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Response to Hand eczema severity	HEES(hand eczema extent score)	2 weeks

Secondary Outcomes

Measure	Description	Time Frame
Response to treatment/Hand eczema severity	Photographic evaluation	2 weeks
Investigator reported improvement	IGA(investigator's global assessment)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
linfeng li, phd	Beijing Friendship Hospital	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Friendship Hospital		Beijing	Beijing Municipality	100000	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided