NCT01759693

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 28, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 3, 2013

Completed
29 days until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

January 3, 2013

Status Verified

December 1, 2012

Enrollment Period

6 months

First QC Date

December 28, 2012

Last Update Submit

January 2, 2013

Conditions

Keywords

Platelet activation

Outcome Measures

Primary Outcomes (1)

  • Platelet activation

    Platelet function will be assessed at enrollment

    6 months

Secondary Outcomes (1)

  • Mean platelet volume

    6 months

Study Arms (2)

Skin disease

Patients with urticaria or atopic dermatitis

Procedure: Blood sampling

Control

Healthy volunteers

Procedure: Blood sampling

Interventions

Blood sampling

ControlSkin disease

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Hospital clinic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir Medical Center

Kfar Saba, 44281, Israel

Location

MeSH Terms

Conditions

UrticariaDermatitis, Atopic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Skin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesSkin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin Diseases, Eczematous

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2012

First Posted

January 3, 2013

Study Start

February 1, 2013

Primary Completion

August 1, 2013

Study Completion

October 1, 2013

Last Updated

January 3, 2013

Record last verified: 2012-12

Locations