Comparison of Immune Response in Normal Volunteers and Patients With Helminth Infections
NCT ID: NCT00004996
Last Updated: 2019-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
90 participants
OBSERVATIONAL
2000-03-20
2015-04-22
Brief Summary
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Normal volunteers and patients with acute helminth (a type of parasite) infections aged 18 years older may be eligible for this study. Following a medical history and physical exam, participants will undergo suction blistering to provide cells needed for study. A suction blister device is attached to the skin of the thigh. A heating element in the device heats the skin to speed blister formation. (This will feel only a slightly warm.) The device is removed after about two hours, when the blisters have formed. The blister tops are removed with sterile scissors. The blistered areas are then treated with special dressings to promote healing and the participant is discharged with further wound care instructions. A small amount of blood (around four tablespoons) may be drawn to compare chemicals in the blood with chemicals in the blister fluid. Participants will be contacted by telephone over the next 72 hours to check on healing. Further follow-up will occur by phone at 6 months and 1 year.
Up to 60 blisters may be produced over a one-year period (in three separate sessions every six months) with no more than 20 raised per session....
Detailed Description
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Normal volunteers and patients with acute helminth (a type of parasite) infections aged 18 years older may be eligible for this study. Following a medical history and physical exam, participants will undergo suction blistering to provide cells needed for study. A suction blister device is attached to the skin of the thigh. A heating element in the device heats the skin to speed blister formation. (This will feel only a slightly warm.) The device is removed after about two hours, when the blisters have formed. The blister tops are removed with sterile scissors. The blistered areas are then treated with special dressings to promote healing and the participant is discharged with further wound care instructions. A small amount of blood (around four tablespoons) may be drawn to compare chemicals in the blood with chemicals in the blister fluid. Participants will be contacted by telephone over the next 72 hours to check on healing. Further follow-up will occur by phone at 6 months and 1 year.
Up to 60 blisters may be produced over a one-year period (in three separate sessions every six months) with no more than 20 raised per session.
Conditions
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Keywords
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Eligibility Criteria
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Inclusion Criteria
2. Access to a primary medical care provider outside of the NIH
3. Able to give informed consent
4. Willingness to have history and physical examination annually
Exclusion Criteria
2. Use of systemic corticosteroids within the past month
3. Use of local corticosteroids at the proposed blistering site within the past month
4. Evidence of current acute infection
5. Personal or family history of keloid formation
6. Use of any investigative drugs within the past month
7. History of skin disease within the past one year (e.g. psoriasis, atopic dermatitis)
8. History of diabetes
18 Years
65 Years
ALL
Yes
Sponsors
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National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Responsible Party
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Principal Investigators
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Thomas B Nutman, M.D.
Role: PRINCIPAL_INVESTIGATOR
National Institute of Allergy and Infectious Diseases (NIAID)
Locations
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National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
Countries
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References
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Kiistala U. Suction blister device for separation of viable epidermis from dermis. J Invest Dermatol. 1968 Feb;50(2):129-37. doi: 10.1038/jid.1968.15. No abstract available.
Blauvelt A, Katz SI, Udey MC. Human Langerhans cells express E-cadherin. J Invest Dermatol. 1995 Feb;104(2):293-6. doi: 10.1111/1523-1747.ep12612830.
Dale DC, Wolff SM. Skin window studies of the acute inflammatory responses of neutropenic patients. Blood. 1971 Aug;38(2):138-42. No abstract available.
Other Identifiers
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00-I-0099
Identifier Type: -
Identifier Source: secondary_id
000099
Identifier Type: -
Identifier Source: org_study_id