Completed

Determination of Cytokine Production Patterns in the Skin of Patients With Systemic Mastocytosis and Atopic Dermatitis Using the Suction Blister Technique

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What is being collected

Data Collection

Who is being recruted

Taxis Response+21

+ Orientation, Spatial

+ Mast Cell Activation Disorders

See all eligibility criteria
How is the trial designed

Observational
Study Start: January 1998
See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: December 13, 2007
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 1998

Actual date on which the first participant was enrolled.

Systemic mastocytosis is a disease characterized by an abnormal accumulation of mast cells in skin, bone marrow and viscera. Precise mechanisms of events leading to the migration and proliferation of mast cells in skin is not known. We propose to investigate the in vivo cytokine and chemokine production patterns of human skin in patients with mastocytosis and compare these findings to those of patients with atopic dermatitis and to healthy volunteers, using the suction blister technique. The cytokines/chemokines of interest in this study are stem cell factor (SCF), interleukin (IL)-3, IL-4, IL-6, IL-9, IL-10, TNF-alpha, TGF-beta, MCP-1 and RANTES, all of which have been shown to take part in the proliferation, differentiation or chemotaxis of mast cells. Our hypothesis is that human skin is producing mediators which allow the mast cells to migrate and proliferate in skin, resulting in the clinical picture of urticaria pigmentosa. Suction blisters will be generated in patients, and the cytokine/chemokine contents of the blister fluids will be analyzed by immunoassay. If the chemokine content of the blister fluid is found to be high, chemotaxis of mast cell precursors to the skin may also be examined in vivo by placing a template filled with sterile saline over the blister sites. Punch biopsies will be performed to correlate cytokine levels with mast cell numbers. This study will aid in understanding the pathogenesis of cutaneous mast cell disease and may provide insights into the regulation of mast cell growth and differentiation in tissue-specific microenvironments. It is hoped that these studies will contribute to the design of novel treatment strategies against mast cell associated skin diseases.

NCT00001760
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: December 13, 2007
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Taxis ResponseOrientation, SpatialMast Cell Activation DisordersBehaviorBehavior, AnimalDermatitisHypersensitivityHypersensitivity, ImmediateImmune System DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNeoplasmsNeoplasms by Histologic TypeNeoplasms, Connective TissueSkin DiseasesSkin Diseases, GeneticSpatial BehaviorSkin and Connective Tissue DiseasesSkin Diseases, EczematousNeoplasms, Connective and Soft TissueGenetic Diseases, InbornChemotaxisDermatitis, AtopicMastocytosisMastocytosis, Systemic

Criteria

General: Age equal to or greater than 18. Access to a primary medical care provider outside of the NIH. Able to give informed consent. No history of malignancy or autoimmune disease such as rheumatoid arthritis, vasculitis, pyoderma gangrenosum, psoriasis. No use of systemic corticosteroids within the past month. No use of local corticosteroids at the proposed blistering site within the past month. No evidence of current acute infection. INR less than or equal to 1.5, PTT less than or equal to 40, platelet count greater than or equal to 100,000/mm(3). No personal or family history of keloid formation. Blood glucose less than or equal to 160. No use of any investigative drugs within the past month. No allergy to lidocaine. Healthy volunteers must not have a history of atopic dermatitis, mastocytosis or chronic urticaria. Mastocytosis: Histologic evidence of mast cell hyperplasia in at least one organ system. Atopic Dermatitis: Must have at least 3 major and 3 minor criteria. No history of mastocytosis.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

National Institute of Allergy and Infectious Diseases (NIAID)

Bethesda, United StatesOpen National Institute of Allergy and Infectious Diseases (NIAID) in Google Maps
CompletedOne Study Center