RecruitingNot a traditional drug phaseinterventionalRules rewrite

Not a traditional drug phase: Data and biospecimen collection for Atopic Dermatitis

This study will explore potential links between atopic dermatitis and food allergy. This information will be useful to determine atopic dermatitis and food allergy share unique biochemical or genetic identifiers useful for diagnosing and treatments in the future.

Official registry: https://clinicaltrials.gov/study/NCT06300697 · University of Michigan · enrollment listed as 200

What this phase means

This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Data and biospecimen collection, Skin biopsies, or Oral Food Challenge (OFC) procedures. The registry lists allocation as randomized. This study will explore potential links between atopic dermatitis and food allergy.

They plan to enroll about 200 people at Ann Arbor. Taking part typically means study visits and measurements plus check-ins.

Official title (unrewritten)

Michigan Food and Atopic Dermatitis (M-FAD) Program - Molecular Analytics Project

Interventions: Data and biospecimen collection, Skin biopsies, Oral Food Challenge (OFC) procedures

Primary outcome (registry wording): Anaphylaxis occurrence rates in each group

Who it is for (from inclusion criteria)

Ages 10 Years to 55 Years
Food allergy-only group
Have a known history of food anaphylaxis to peanut, tree nut, egg, milk, or sesame confirmed by an allergist
No history of atopic dermatitis
Food allergy plus atopic dermatitis group who can join:
\- Meet the "food allergy only group" who can join except this group must also have atopic dermatitis
Atopic dermatitis without food allergy who can join:
Have a present diagnosis of atopic dermatitis by an allergist and/or dermatologist

Who the registry excludes

People younger than age 10 or older than age 55
Any medication use that cannot be stopped temporarily for the OFC that would interfere with the OFC result. Medications in this category include antihistamines (first or second generation) within 1 week
Any skin condition aside from atopic dermatitis per who can join groups that might impact the study, including such conditions as autoimmune skin conditions (such as psoriasis), congenital ichthyoses, hyper-IgE syndromes
Any recent change (within 6 months) of starting or stopping a biologic medication, such as dupilumab, tezepelumab, or others that might interfere with atopic dermatitis or food allergy
Any past or present history of oral immunotherapy (OIT) for any food allergen
Pregnancy - females of childbearing age will be asked and self-report pregnancy status

Public study contact (from the registry)

Bridgette Kaul

734-647-8284

foodallergyclinicalresearch@med.umich.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

University of Michigan — Ann Arbor, Michigan (recruiting)

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FAQ about this NCT record

Is NCT06300697 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06300697?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06300697?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary