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Reliability of Expired Allergens in Patch Testing: A Comparative Study With Non-Expired Series

NCT07765563 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-08-14

No results posted yet for this study

Summary

Patch testing remains the gold standard in the diagnosis of allergic contact dermatitis. Patches used in testing consist of a wide spectrum of allergens, with variability in the stability of products over time. Due to limited allergen stability, careful storage and preparation is needed to prevent product degradation over time. Expiration dates are provided by manufacturers to ensure stability and reactivity, while minimizing the risk of product degradation contributing to inaccurate testing results. Preparation of patch series can be time intensive and procurement of allergens comes with an associated economic burden. Expired allergens are not routinely used in patch testing, however many clinics have expired allergens accessible. There is paucity of evidence comparing the reactivity of expired vs non-expired patch series. If expired allergens remain effective, this could result in significant cost-savings and accessibility implications for dermatology practice.

Conditions

  • Allergic Contact Dermatitis

Interventions

BIOLOGICAL

Patch 1 (Expired)

All enrolled participants will be simultaneously patch tested with both expired and non-expired patches. Therefore, there is no difference in intervention amongst study participants.

BIOLOGICAL

Patch 2 (non-expired)

All enrolled participants will be simultaneously patch tested with both expired and non-expired patches. Therefore, there is no difference in intervention amongst study participants.

Sponsors & Collaborators

Principal Investigators

  • Laurie Parsons, Medical Doctor · University of Calgary

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07765563 on ClinicalTrials.gov