Platelet Activation in Chronic Inflammatory Skin Diseases | NCT01759693

Studies
Platelet Activation in Chronic Inflammatory Skin Diseases

NCT01759693

Sponsor

Meir Medical Center

Status

Unknown status

Last Update Posted

Jan 3, 2013Estimated

Enrollment

80Estimated

Phase

Not provided

Conditions

Urticaria
Atopic Dermatitis

Interventions

Blood sampling

Countries

Israel

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

ID	Type	Description	Link
MMC 0113	Other Identifier	Meir Medical Center

Status Module

Record Verification Date

Dec 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2013

Primary Completion Date

Aug 2013Estimated

Completion Date

Oct 2013Estimated

First Submitted Date

Dec 28, 2012

First Submission Date that Met QC Criteria

Jan 2, 2013

First Posted Date

Jan 3, 2013Estimated

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 2, 2013

Last Update Posted Date

Jan 3, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Platelets are blood cells that are important in coagulation of the blood. These cells have recently been shown to play a role in a number of other biologic processes, for example inflammation. In this study the investigators will determine the extent of platelet activation in people suffering from common chronic skin inflammation-urticaria and allergic dermatitis.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Skin disease		Patients with urticaria or atopic dermatitis	Procedure: Blood sampling
Control		Healthy volunteers	Procedure: Blood sampling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood sampling	Procedure	Blood sampling	Control Skin disease

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Platelet activation	Platelet function will be assessed at enrollment	6 months

Secondary Outcomes

Measure	Description	Time Frame
Mean platelet volume	Mean platelet volume will be assessed at enrollment	6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria: Urticaria or atopic dermatitis -

Exclusion Criteria:Lack of informed consent

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Hospital clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Meir Medical Center		Kfar Saba		44281	Israel

Condition Browse Module

MeSH Terms

ID	Term
D014581	Urticaria
D003876	Dermatitis, Atopic

Ancestor Terms

ID	Term
D017445	Skin Diseases, Vascular
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D006969	Hypersensitivity, Immediate

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided