UrticariaNCT01759693
Platelet Activation in Chronic Inflammatory Skin Diseases
An observational study of Urticaria and Atopic Dermatitis, run by Meir Medical Center at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Urticaria, Atopic Dermatitis
- What is being tested?
- Blood sampling
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2013to Oct 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Hospital clinic
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Israel1 site
Meir Medical Center
Kfar Saba, 44281
Martin H Ellis, MD, 972-9-7471822, martinel@clalit.org.il
Martin H Ellis, MD
About this study
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.
- Conditions
- Urticaria, Atopic Dermatitis
- Being tested
- Blood sampling
- Keywords
- Platelet activation
- Medical subject headings
- Urticaria, Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingProcedure or surgery
Blood sampling
| Study group | Role | What they receive |
|---|---|---|
| Skin disease | Patients with urticaria or atopic dermatitis Receives: Procedure: Blood sampling | |
| Control | Healthy volunteers Receives: Procedure: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet activation
Platelet function will be assessed at enrollment
Measured: 6 months
Secondary outcomes (1)
Mean platelet volume
Mean platelet volume will be assessed at enrollment
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionAug 2013 (estimated)
- Study completionOct 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrticariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01759693
- Sponsor's protocol ID
- 0113
- Other IDs
- MMC 0113
- Status last verified
- Dec 2012
- First submitted
- 28 Dec 2012
- Last updated
- 3 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Activation in Chronic Inflammatory Skin Diseases
- ClinicalTrials.gov ID
- NCT01759693
- Acronym / sponsor ID
- 0113
- Conditions
- Urticaria, Atopic Dermatitis
- Keywords
- Platelet activation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Oct 2013 (estimated)
- First posted
- 3 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Skin disease | – | Procedure: Blood samplingPatients with urticaria or atopic dermatitis |
| Control | – | Procedure: Blood samplingHealthy volunteers |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Hospital clinic
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingBlood sampling | Procedure or surgery | Control, Skin disease |
Primary outcome
Platelet activation
Time frame: 6 months
Platelet function will be assessed at enrollment
1 secondary outcome
Mean platelet volume
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Urticaria and Atopic Dermatitis, run by Meir Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet activation (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2013.