Exploring immune responses in diseases like psoriasis and eczema
Metabolic Profiling of Immune Responses in Immune-Mediated Diseases
This study is trying to see how the immune system works in people with psoriasis and eczema, as well as healthy volunteers, to better understand their skin healing and find new treatment options.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT04864886 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the metabolic profiles associated with immune-mediated diseases, including primary immunodeficiency, psoriasis, and atopic dermatitis. Participants aged 18-75, including healthy volunteers, will undergo screening, medical history assessments, and physical exams. The study involves collecting skin biopsies, blood samples, and other biological materials to analyze how immune responses and skin healing are interconnected. The goal is to better understand the metabolic changes that occur in these conditions to inform future treatments.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18-75 with primary immune deficiency, psoriasis, atopic dermatitis, or healthy volunteers.
Not a fit: Patients with clinically apparent monogenic or digenic immune defects, or those without the specified conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatments for patients with immune-mediated diseases.
How similar studies have performed: While this approach is exploratory, similar studies have shown promise in understanding immune responses and metabolic changes in related conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
* 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.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Ian A Myles, M.D. — National Institute of Allergy and Infectious Diseases (NIAID)
- Study coordinator: Jodi L Blake, R.N.
- Email: jodi.blake@nih.gov
- Phone: (301) 605-2896
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.