In short
Clinical trials investigating ZINC CHLORIDE are studying its use as a patch test allergen in people with allergic contact dermatitis, and in one trial, eczema. These studies aim to assess diagnostic performance, safety, and agreement between testing methods. The target population is adults or other participants with suspected metal allergy.
Key points
- Clinical trials investigating ZINC CHLORIDE are looking at its role in metal panel patch testing for allergic contact dermatitis, and in one record, eczema. Both studies are Phase 3 and focus on diagnostic performance and safety rather than treatment. The main endpoint is agreement between hydrogel and petrolatum patch testing methods. One trial record is withdrawn and the other is authorised. The participant groups are people with suspected metal allergy or related skin conditions.
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. The study is listed as an interventional study, which means researchers actively test the patch test method in participants.
Two records are shown for the same trial ID, with different status and enrollment numbers: one is Withdrawn and the other is Authorised. Both records are Phase 3 studies.
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. One record also includes eczema as a condition studied.
The source data do not give full eligibility rules, so we cannot say exactly who could join beyond the listed conditions. The intervention list suggests the study involved testing for several metal allergens, including ZINC CHLORIDE.
What was tested
ZINC CHLORIDE appears in the study as Zinc Allergen (zinc chloride 1%) used by cutaneous, or skin, application. The panel also included other metal allergens such as nickel, copper, tin, manganese, gold, sodium, vanadium, chromium, cobalt, and ammonium-related compounds.
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. Diagnostic efficacy means how well the test helps find the allergy correctly.
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. The study used Cohen’s kappa and positive and negative percent agreement to measure that agreement.
These measures help show whether the new testing approach gives results similar to the reference method. The source data do not list any secondary endpoints beyond the safety and performance goals in the summary.
Trial status and size
One record reports enrollment of 300 participants and the status Withdrawn. The other record reports enrollment of 395 participants and the status Authorised.
Because both records use the same NCT number, they appear to be different registry entries or updates for the same study. The source data do not explain why the status differs.
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. 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.
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. The trial data point to people with allergic contact dermatitis, and in one record, eczema, as the main groups of interest.