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Skin Immunity Sample Collection for Weak Immune Systems

Phase < 1
Waitlist Available
Led By Ian A Myles, M.D.
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Between the age limits of 18 and 65 years old for healthy volunteers; 7 and 65 years old for patients with CGD; 18 and 65 years old for patients with HIES.
Must not have
For individuals undergoing blister or skin biopsy procedures, history of keloid formation.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout study
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether different liquids applied to the skin can help heal blisters and improve the immune response in people with weak immune systems.

Who is the study for?
This trial is for people aged 18-65 with hyper IgE syndrome or Job syndrome, those aged 7-65 with chronic granulomatous disease, and healthy volunteers of the same age range. Participants must be willing to allow their samples to be stored for research and able to give informed consent. Those with a history of severe scarring, recent blood thinners or immunomodulatory drugs use, or pregnancy cannot join.
What is being tested?
Researchers are studying how the immune system relates to skin healing by inducing blisters and taking skin biopsies from participants. They will collect blister fluid and small pieces of skin using a suction device and sharp tool respectively. Some may have an overnight visit where their wounds are treated with saline or their own blood serum.
What are the potential side effects?
Participants might experience discomfort from the blistering process and minor pain from biopsy procedures. There's also a risk of infection at the site of these interventions as well as potential bruising or bleeding.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am within the age range required for my health status.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a history of keloid formation after skin procedures.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~throughout study
This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout study for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Fold induction in genes related to wound healing.
T-cell infiltration as percent of total cell infiltration in patients with CGD versus healthy volunteers.
Tumor necrosis factor alpha (TNFa) production by keratinocytes from patients with HIES versus healthy volunteers

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: 2Experimental Treatment1 Intervention
Skin Biopsies
Group II: 1Experimental Treatment1 Intervention
Blister Induction

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,336 Previous Clinical Trials
5,392,764 Total Patients Enrolled
Ian A Myles, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)
5 Previous Clinical Trials
530 Total Patients Enrolled

Media Library

1 Clinical Trial Eligibility Overview. Trial Name: NCT03921515 — Phase < 1
Job's syndrome Research Study Groups: 1, 2
Job's syndrome Clinical Trial 2023: 1 Highlights & Side Effects. Trial Name: NCT03921515 — Phase < 1
1 2023 Treatment Timeline for Medical Study. Trial Name: NCT03921515 — Phase < 1
~0 spots leftby Jan 2026
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