Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004996
Status:
COMPLETED
Last Update Posted:
2019-12-12
First Post:
2000-03-22
Brief Title:
Comparison of Immune Response in Normal Volunteers and Patients With Helminth Infections
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Langherhans Cell Function and Inflammatory Responses in Skin of Volunteers Using the Suction Blister Technique
Status:
COMPLETED
Status Verified Date:
2015-04-22
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 00-I-0099 | None | None | None |