Pathogenesis of Physical Induced Urticarial Syndromes
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ClinicalTrials.gov Identifier: NCT00887939 |
Recruitment Status :
Active, not recruiting
First Posted : April 24, 2009
Last Update Posted : April 3, 2024
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Tracking Information | |||||
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First Submitted Date | April 23, 2009 | ||||
First Posted Date | April 24, 2009 | ||||
Last Update Posted Date | April 3, 2024 | ||||
Actual Study Start Date | June 17, 2009 | ||||
Primary Completion Date | Not Provided | ||||
Current Primary Outcome Measures |
to determine the role of mast cell activation and genetic predisposition in the pathogenesis of physically induced urticaria. [ Time Frame: 12/31/2028 ] The patient s physical urticaria will be verified through standard testing.
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Original Primary Outcome Measures | Not Provided | ||||
Change History | |||||
Current Secondary Outcome Measures | Not Provided | ||||
Original Secondary Outcome Measures | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Pathogenesis of Physical Induced Urticarial Syndromes | ||||
Official Title | Pathogenesis and Genetic Basis of Physical Induced Urticarial Syndromes | ||||
Brief Summary | Background:
Objectives:
Eligibility:
Design:
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Detailed Description | Urticaria is a common skin disorder that is classified according to its chronicity into acute and chronic forms. It may occur spontaneously or on exposure to a physical factor. In the latter case, the urticaria is classified as a physical urticaria . Physical urticaria may be induced by mechanical and applied pressure, exercise, or exposure to cold, heat, sun, water, or vibration. The urticarial lesions are generally thought to be the result of mast cell activation and degranulation, which is supported by the finding of increased levels of serum histamine during some urticarial flares. Passive transfer experiments, whereupon serum from affected donors is transferred into recipient s skin followed by physical stimulation with resultant urticaria at the site of challenge, have been positive in some instances. This suggests the presence of an intrinsic factor in serum, such as IgE, which then mediates activation of tissue mast cells. However, the pathogenesis in general remains unclear and a genetic basis for these disorders has not been elucidated. The goal of this protocol is thus to gain a better understanding of the pathogenesis of physical urticaria through the investigation of subjects with severe and unusual phenotypes and/or inherited patterns of disease. Subjects will undergo a clinical evaluation that will include verification of their urticaria. Blood and tissue samples, if available, will be collected for analysis. The analysis will be targeted toward the determination of novel serum mediators, mast cell activation and mutational analysis in families with inherited patterns. |
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Study Type | Observational | ||||
Study Design | Observational Model: Case-Control Time Perspective: Cross-Sectional |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Non-Probability Sample | ||||
Study Population | Primary clinical | ||||
Condition |
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Intervention | Not Provided | ||||
Study Groups/Cohorts |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Active, not recruiting | ||||
Actual Enrollment |
173 | ||||
Original Enrollment |
200 | ||||
Study Completion Date | Not Provided | ||||
Primary Completion Date | Not Provided | ||||
Eligibility Criteria |
Affected subjects/guardian must:
Non-affected relatives/guardian must:
Healthy volunteers must:
EXCLUSION CRITERIA: The following criteria apply to all subjects:
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Sex/Gender |
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Ages | 2 Years to 90 Years (Child, Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT00887939 | ||||
Other Study ID Numbers | 090126 09-I-0126 |
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Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Current Responsible Party | National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ) | ||||
Original Responsible Party | Not Provided | ||||
Current Study Sponsor | National Institute of Allergy and Infectious Diseases (NIAID) | ||||
Original Study Sponsor | Same as current | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | National Institutes of Health Clinical Center (CC) | ||||
Verification Date | March 7, 2024 |