Study of Omalizumab Treatment Effects on Skin Barrier in Children and Adults with Food Allergy Phase IV Open-Label Trial Evaluating Skin Changes and Food Challenge Responses

What this Trial Is About

This research aims to understand whether skin barrier problems occur in people with food allergies confirmed by positive oral food challenges OFC. It also evaluates if these skin barrier issues can be improved with treatment using omalizumab. The study includes both food allergic participants and a comparison group of non-food allergic individuals to observe differences in skin barrier function. Participants with food allergies will receive omalizumab injections for four months and undergo multiple skin barrier tests, including transepidermal water loss TEWL and skin tape strip STS analyses. Oral food challenges will be performed before and after treatment to measure allergic reactions. A control group without food allergies will have similar skin barrier assessments but will not receive omalizumab. Participants will have an initial screening to confirm eligibility, including allergy tests and an oral food challenge. During the study, skin assessments will be done before doses and at the midpoint of treatment. After four months of omalizumab, a final oral food challenge and skin assessments will be completed. Researchers will analyze skin lipids, metabolites, proteins, and cytokines, tracking changes over five months to evaluate treatment effects and safety.

Effect of Omalizumab in the Skin of Food Allergy Patients