Table of contents

• Trial overview
• Who was studied
• What was tested
• Trial endpoints and outcomes
• Trial status and size
• What these trials mean for patients

Trial overview

The available records describe one clinical study, NCT04500834, for a metal panel patch test that includes ZINC CHLORIDE as one of the allergens being studied.^[1] The study is listed as an interventional study, which means researchers actively test the patch test method in participants.^[1]

Two records are shown for the same trial ID, with different status and enrollment numbers: one is Withdrawn and the other is Authorised.^{[1][1] Both records are Phase 3 studies.[1][1]}

Who was studied

The trials focus on people with allergic contact dermatitis, which is a skin allergy caused by contact with a trigger on the skin.^{[1][1] One record also includes eczema as a condition studied.[1]}

The source data do not give full eligibility rules, so we cannot say exactly who could join beyond the listed conditions.^{[1][1] The intervention list suggests the study involved testing for several metal allergens, including ZINC CHLORIDE.[1][1]}

What was tested

ZINC CHLORIDE appears in the study as Zinc Allergen (zinc chloride 1%) used by cutaneous, or skin, application.^{[1][1] The panel also included other metal allergens such as nickel, copper, tin, manganese, gold, sodium, vanadium, chromium, cobalt, and ammonium-related compounds.[1][1]}

The brief summary says the study aimed to evaluate the diagnostic efficacy and safety of the investigational allergens, as well as the safety and performance of the panel device constituent.^{[1][1] Diagnostic efficacy means how well the test helps find the allergy correctly.[1][1]}

Trial endpoints and outcomes

The main outcome was concordance, which means agreement, between two patch testing methods: a hydrogel investigational allergen method and a petrolatum reference allergen method.^{[1][1] The study used Cohen’s kappa and positive and negative percent agreement to measure that agreement.[1][1]}

These measures help show whether the new testing approach gives results similar to the reference method.^{[1][1] The source data do not list any secondary endpoints beyond the safety and performance goals in the summary.[1][1]}

Trial status and size

One record reports enrollment of 300 participants and the status Withdrawn.^[1] The other record reports enrollment of 395 participants and the status Authorised.^[1]

Because both records use the same NCT number, they appear to be different registry entries or updates for the same study.^{[1][1] The source data do not explain why the status differs.[1][1]}

What these trials mean for patients

For patients, these studies are about improving how doctors identify metal allergies on the skin, not about treating the allergy itself.^{[1][1] ZINC CHLORIDE is being used as one of several patch test allergens in a broader panel, so the focus is on test accuracy and safety.[1][1]}

In simple terms, the researchers want to know whether the patch test results from the study method match the reference method well enough to be trusted.^{[1][1] The trial data point to people with allergic contact dermatitis, and in one record, eczema, as the main groups of interest.[1][1]}