CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 51 enrolled
Drug / intervention
Transepidermal water loss (TEWL) monitor and stopping rules +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05696236
NCT05696236N/ACompleted

Transepidermal Water Loss as a Predictor for Severe Allergic Reactions in Oral Food Challenges

University of Michigan·interventional·Posted Jan 25, 2023·Updated Aug 19, 2025

In Brief

A clinical study evaluating Transepidermal water loss (TEWL) monitor and stopping rules and Monitor (TEWL) without stopping rules for Anaphylaxis Food. Completed, enrolled 51 participants across 1 site.

Detailed Summary

This research study is testing a new way to look for the early stages of anaphylaxis. Eligible participants will have a small monitor (transepidermal water loss) placed on the forearm during a food challenge (for peanut allergies). This monitor continuously records the amount of water lost through the skin. In a previous study the team learned what values are associated with an anaphylactic reaction. These values are called "stopping rules." This study is looking at whether it can use these new stopping rules to end the oral food challenge before a person may show any symptoms.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2023202420252026
First PostedJan 25, 2023
Enrollment StartMay 23, 2023
Primary CompletionAug 29, 2024
Study CompletionAug 30, 2024
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 3.4 years ago

Interventions

Transepidermal water loss (TEWL) monitor and stopping rulesdevice

The oral food challenge will be done as usual, and participants will wear the TEWL monitor. The research food allergy nurse and doctor will also be looking for signs and symptoms of an allergic reaction. The research study coordinator will be watching the TEWL numbers. If they numbers match the stopping rules, they will tell the doctor and the oral food challenge will be over.

Monitor (TEWL) without stopping rulesdevice

The oral food challenge will be done as usual, and participants will wear the TEWL monitor. The research food allergy nurse and doctor will be looking for signs and symptoms of an allergic reaction. The research study coordinator will be watching the TEWL numbers, but the stopping rules will not be used to end the oral food challenge.