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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout study
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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

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
3,269 Previous Clinical Trials
5,481,399 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
Hyper IgE Syndrome Research Study Groups: 1, 2
Hyper IgE 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this experiment involve participants over the age of forty?

"For this medical trial, enrolment is restricted to individuals aged 7-65. There are 16 specific trials tailored for those under 18 and 13 designed specifically for older adults over 65 years old."

Answered by AI

Am I eligible to partake in this research program?

"To partake in this medical trial, applicants must be within the age range of 7 and 65 years old with a diagnosis of granulomatous disease. This study is currently seeking to recruit 70 participants."

Answered by AI

Is this trial taking in new participants?

"Unfortunately, patient recruitment for this study has been halted as of December 1st 2022. Nevertheless, 21 other medical trials are presently enrolling volunteers."

Answered by AI
~47 spots leftby Sep 2024