Table of Contents
- Trial overview
- Who the trials include
- What is being measured
- Trial status and size
- Study products and comparators
- What the results aim to show
Trial overview
The source data lists one clinical study ID, NCT04500834, with two records for the same study. Both records are interventional studies, which means researchers are giving a test product and then measuring the results.[1][1]
The study is a phase 3 trial, so it is being tested in a larger group to learn more about how well the patch test method works in real use.[1][1]
The trial title is Metal Panel Patch Test.[1][1]
Who the trials include
The trials are focused on people with allergic contact dermatitis, which is a skin allergy caused by contact with a trigger substance.[1][1]
One record also includes eczema, a skin condition that can cause dry, itchy, and inflamed skin.[1]
The source data does not give the full joining rules, so it does not say exactly who can or cannot take part beyond these conditions.[1][1]
What is being measured
The main outcome is concordance, which means agreement between two patch testing methods.[1][1]
The study uses Cohen’s kappa, a statistical measure that shows how much two methods agree beyond chance.[1][1]
The trial also measures positive percent agreement and negative percent agreement, which show how often the two methods match when the result is positive or negative.[1][1]
The brief summary says the study is also looking at diagnostic efficacy, which means how well the test helps identify allergy, and at overall safety and performance of the investigational panel device.[1][1]
Trial status and size
One record is marked Authorised and has an enrollment of 395 people.[1]
The other record is marked Withdrawn and has an enrollment of 300 people.[1]
Because both records share the same study ID, they appear to describe different status records for the same clinical study rather than separate trials.[1][1]
Study products and comparators
SODIUM TETRACHLOROPALLADATE appears in the study as a sodium allergen used in patch testing.[1][1]
The study also includes several other metal allergens, such as copper, tin, manganese, zinc, gold, vanadium, cobalt, nickel, chromium, and ammonium titanium oxide oxalate.[1][1]
The primary comparison is between a hydrogel investigational allergen and a petrolatum reference allergen. Hydrogel is a gel-based testing method, while petrolatum is a grease-based reference used for comparison.[1][1]
What the results aim to show
The trial aims to learn whether the investigational allergen panel gives results that match the reference method well enough to support diagnostic use.[1][1]
It also aims to check the safety and performance of the panel device constituent, which means the part of the test system that carries the allergens onto the skin.[1][1]
In simple terms, the study is asking whether the patch test method can reliably help identify metal allergies in people with skin symptoms linked to contact exposure.[1][1]
