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Comparison of Immune Response in Normal Volunteers and Patients With Helminth Infections
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), January 2009
First Received: March 22, 2000   Last Updated: August 24, 2009   History of Changes
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00004996
  Purpose

This study will compare the structure, chemical composition and other characteristics of skin and blood in people with and without parasitic infections. Cell samples will be taken from blisters produced by suction blistering. This study may provide new information about the interactions between parasites and the immune system that could lead to better treatments for these infections.

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....


Condition
Healthy
Helminthiasis

Study Type: Observational
Official Title: Langherhans' Cell Function and Inflammatory Responses in Skin of Normal Volunteers and Patients With Helminth Infections Using the Suction Blister Technique

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 120
Study Start Date: March 2000
Estimated Primary Completion Date: February 2003 (Final data collection date for primary outcome measure)
Detailed Description:

This study will compare the structure, chemical composition and other characteristics of skin and blood in people with and without parasitic infections. Cell samples will be taken from blisters produced by suction blistering. This study may provide new information about the interactions between parasites and the immune system that could lead to better treatments for these infections.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

  • INCLUSION CRITERIA:

    1. Between the ages of 18 and 65 years inclusive
    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:

  1. History of malignancy or autoimmune disease such as rheumatoid arthritis, vasculitis, pyoderma gangrenosum
  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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004996

Contacts
Contact: Patient Recruitment and Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov
Contact: TTY 1-866-411-1010

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

Additional Information:
NIH Clinical Center Detailed Web Page  This link exits the ClinicalTrials.gov site

Publications:
Kiistala U. Suction blister device for separation of viable epidermis from dermis. J Invest Dermatol. 1968 Feb;50(2):129-37. No abstract available.
Blauvelt A, Katz SI, Udey MC. Human Langerhans cells express E-cadherin. J Invest Dermatol. 1995 Feb;104(2):293-6.
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.

Study ID Numbers: 000099, 00-I-0099
Study First Received: March 22, 2000
Last Updated: August 24, 2009
ClinicalTrials.gov Identifier: NCT00004996     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Antigen Presentation
Cytokines
Dendritic Cells
Helminth
 Th2
Healthy Volunteer
Helminth Infection

Additional relevant MeSH terms:
Parasitic Diseases
Infection
Helminthiasis

ClinicalTrials.gov processed this record on November 25, 2009



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