Recruiting

Immune Profiling

Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Code:

NCT04864886

Conditions

Primary Immunodeficiency

Psoriasis

Atopic Dermatitis

Immune-mediated Diseases

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Study Details

Brief summary:

Background:

The immune system is the part of the body that fights infection. Some people have immune deficiencies that cause skin rashes, make them get sick often with infections, or make it difficult for their skin to heal. Researchers want to learn more to better treat conditions that affect immune response.

Objective:

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

Eligibility:

People ages 18-75 with primary immune deficiency, eczema, or psoriasis. Healthy volunteers are also needed.

Design:

Participants will be screened with a medical and medicine history and a physical exam. They may take a pregnancy test.

Participants will discuss the medicines or supplements they take as well as skin products they use, such as soaps and lotions.

Participants will have up to 4 skin biopsies taken from the forearm. A needle will inject an anesthetic into the skin where the biopsy will be done. A sharp tool that looks like a tiny cookie cutter will be used to remove a round plug of skin a bit smaller than the tip of a pencil.

Participants will give at least 1 blood sample.

Participants may have optional skin swab collection. A cotton swab will be used to swab the skin on the arm.

Participants may have optional skin tape collection. A sticky strip of tape will be placed on the arm and then removed.

Participants may give leftover samples taken as part of their regular medical care.

Participation will last for about 4 days. Participants will have 2 visits that each last about 1 hour. They may be asked to repeat the study in the future.

Conditions

Primary Immunodeficiency

Psoriasis

Atopic Dermatitis

Immune-mediated Diseases

Study ID

NCT04864886

Start date

Aug 10, 2021

Status verified date

Aug 26, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

  • INCLUSION CRITERIA:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Meets one of the following:

1. Has documentation of PID confirmed by genetic evaluation demonstrating a deleterious variant in the gene (or genes) known to be associated with immune deficiency (confirmed PID); or
2. Has documented variant of undetermined significance in a gene (or genes) that is predicted to be deleterious in immune function by the investigators OR a clinical history of infections which are more frequent, more chronic, or more severe than normal (suspected PID); or
3. Has physician-diagnosed psoriasis; or
4. Has physician-diagnosed AD; or
5. Does not have clinically apparent evidence of any monogenic or digenic immune defect, AD, or psoriasis (healthy volunteers).
2. Aged 18 to 75 years.
3. Willing to allow storage of blood, biopsy tissue, bacterial and fungal cultures, and any other samples collected for future research.
4. Able to provide informed consent.

EXCLUSION CRITERIA:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Current or prior (within 3 months) anticoagulant or anti-platelet therapy (other than aspirin or non-steroidal anti-inflammatory drugs).
2. Current or prior (within 3 months) use of immunomodulatory drugs (eg, chemotherapy, steroids), except if approved by the principal investigator.
3. History of keloid formation.
4. Pregnancy, lactating, or breastfeeding.
5. Any condition that, in the opinion of the investigator, contraindicates participation in the study.

Co-enrollment guidelines: Participants may be co-enrolled in other studies; however, study staff should be notified of co-enrollment.

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

Healthy volunteers

Control group

Patients with atopic dermatitis

Physician-diagnosed atopic dermatitis

Patients with primary immunodeficiency

Confirmed by genetic diagnosis or suspected by genetic variant of unconfirmed significance and a history consistent with immunodeficiency

Patients with psoriasis

Physician-diagnosed psoriasis

Primary outcome measure

  • Change in relative abundance of microbial skin taxa and/or skin metabolites associated with wound healing or immune mediated disorders. [ Time Frame: Throughout study ]
  • Fold difference in metabolic pathways associated with immune pathways. [ Time Frame: Throughout study ]
  • Fold differences in metabolic pathways related to wound healing. [ Time Frame: Throughout study ]

Central Contacts and Locations

Central contacts

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

800-411-1222prpl@cc.nih.gov

More Information

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Last update posted

Sep 22, 2026

Last verified

Aug 26, 2026

Keywords

  • Primary Immunodeficiency
  • Psoriasis
  • Atopic Dermatitis
  • pathways
  • Natural History

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-28. This information was provided to ClinicalTrials.gov by National Institute of Allergy and Infectious Diseases (NIAID) on 2026-09-22. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.