Table of Contents

• Trial overview
• Who the studies are for
• What VANADIUM OXIDE SULFATE is being studied for
• Main outcomes and endpoints
• Study phase and status
• Trial summary

Trial overview

The available trial records describe a study called Metal Panel Patch Test and identify VANADIUM OXIDE SULFATE as one of the patch test allergens being studied.^[1] The study is listed as an interventional trial, which means researchers actively test a patch method rather than only observing people.^[1]

The records show the same study ID, NCT04500834, with two status entries: Withdrawn and Authorised.^{[1][1] Both records describe a Phase 3 study focused on patch testing and metal allergens.[1][1]}

Who the studies are for

The target conditions are allergic contact dermatitis and, in one record, eczema.^{[1][1] These are skin conditions, and allergic contact dermatitis happens when the skin reacts to something it touches.[1][1]}

The trial data do not list detailed age limits, sex limits, or other participation rules. Based on the source, the main population is people being tested for metal-related skin allergy.^[1][1]

What VANADIUM OXIDE SULFATE is being studied for

In these records, VANADIUM OXIDE SULFATE appears as Vanadium Allergen at 1.3% for cutaneous use, meaning it is placed on the skin as part of patch testing.^{[1][1] It is studied alongside other metal allergens such as nickel, copper, tin, manganese, zinc, gold, sodium, ammonium, cobalt, and chromium.[1][1]}

The trial is not presented as a treatment study. Instead, it is a diagnostic study, meaning it is trying to see how well the test identifies allergy and how well two test methods perform.^[1][1]

Main outcomes and endpoints

The primary outcome is concordance, which means agreement, between the hydrogel investigational allergen method and the petrolatum reference allergen method.^{[1][1] The study measures this using Cohen’s kappa, a statistic that checks agreement beyond chance, and by positive and negative percent agreement.[1][1]}

The brief summary says the objective is to evaluate the diagnostic efficacy and safety of the investigational allergens and the overall safety and performance of the panel device constituent.^{[1][1] In simple terms, the researchers want to know whether the test works well and whether it can be used safely in patch testing.[1][1]}

Study phase and status

Both records list the study as Phase 3.^{[1][1] Phase 3 studies are later-stage studies that usually focus on how well a method works in a larger group of people.[1][1]}

One record is marked Withdrawn with planned enrollment of 300 people, while the other is marked Authorised with planned enrollment of 395 people.^{[1][1] The source does not explain why the status differs, so the records should be read as separate registry entries for the same study ID.[1][1]}

Trial summary

Overall, the clinical trial data for VANADIUM OXIDE SULFATE focus on patch testing in people with allergic contact dermatitis, and in one record, eczema.^{[1][1] The study compares two ways of doing patch tests and checks how closely the results match.[1][1] The main endpoint is agreement between methods, not symptom relief or treatment of disease.[1][1]}

The records provide a clear research focus: diagnostic performance, safety, and practical use of the allergen panel in skin testing.^[1][1]