Completed

Langherhans' Cell Function and Inflammatory Responses in Skin of Volunteers Using the Suction Blister Technique

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What is being collected

Data Collection

Who is being recruted

Infections+1

+ Parasitic Diseases

+ Helminthiasis

From 18 to 65 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Observational
Study Start: March 2000
See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: December 12, 2019
Sourced from a government-validated database.Claim as a partner

Study start date: March 20, 2000

Actual date on which the first participant was enrolled.

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.

NCT00004996
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: December 12, 2019
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

90 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.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

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

Conditions

Pathology

InfectionsParasitic DiseasesHelminthiasisTrematode Infections

Criteria

8 exclusion criteria prevent from participating
Evidence of current acute infection

History of diabetes

History of malignancy or autoimmune disease such as rheumatoid arthritis, vasculitis, pyoderma gangrenosum

History of skin disease within the past one year (e.g. psoriasis, atopic dermatitis)

Show More Criteria

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 Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, United StatesOpen National Institutes of Health Clinical Center, 9000 Rockville Pike in Google Maps
CompletedOne Study Center