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Skin Immunity Sample Collection Involving Blisters and Biopsies

NCT03921515 · Status: WITHDRAWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL

Last updated 2024-12-13

No results posted yet for this study

Summary

Background:

The way the body heals and protects itself from getting sick is called the immune response. Some people with weak immune systems get sick often or get rashes and skin infections. Researchers want to find out how the immune system and skin problems are related so they can help these people.

Objective:

To learn about how immune response and skin healing are related to each other.

Eligibility:

People ages 18-65 with hyper IgE syndrome or Job syndrome or people ages 7-65 with chronic granulomatous disease. Healthy volunteers ages 18 65 are also needed.

Design:

Participants will be screened with:

Medical history

Physical exam

Possible urine tests

Participants will have 1 to 3 visits within about a week. Visits will include the following:

Participants will have a wells device strapped to the inside of the forearm. It will suction the skin and pull the top layer away to form 8 blisters. The skin over the blisters and the liquid inside will be collected.

Participants will have up to 4 skin biopsies. A sharp tool will remove a small plug of skin from the forearm.

Participants may have blood and urine tests.

The skin on participants skin will be rubbed with a cotton swab.

Some participants will have an overnight visit. They will have the blister device placed back on the arm. The wells will be lined up over the blister wounds. The wells will be filled with either saline or the participant s blood serum. The device will be covered and left on the arm for up to 24 hours. Doctors will periodically remove some liquid from the wells.

Conditions

  • Hyper-Immunoglobulin E. Syndrome (HEIS)
  • Chronic Granulomatous Disease (CGD)

Interventions

OTHER

Blister induction

Blister induction involves creating 8 blisters on the forearm and removing the tops of the blisters for primary cell culture derivation. After blister induction, subjects may have an optional overnight admission to assess cell infiltration in response to autologous serum and/or sterile saline solution.

OTHER

Skin Biopsies

The skin biopsies will involve up to 4 biopsies: 2 initial punch biopsies 2 mm in diameter, followed by a punch biopsy 3 (plus or minus 1) and 7 (plus or minus 2) days later using a 3 mm punch to encompass the initial biopsy sites, capturing the tissue at 3 and 7 days of healing.

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Ian A Myles, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-09
Primary Completion
2024-12-10
Completion
2024-12-10

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03921515 on ClinicalTrials.gov