In short
Clinical trials of GOLD SODIUM THIOSULFATE are studying its use in patch testing for metal allergy, especially allergic contact dermatitis. These trials look at how well the test works and how safe it is, mainly in people with suspected metal-related skin allergy.
Key points
- Clinical trials of GOLD SODIUM THIOSULFATE are looking at metal allergy patch testing in people with allergic contact dermatitis, and in one record, eczema as well. Both records are Phase 3 interventional studies. The main question is whether the hydrogel test agrees with the petrolatum reference test. Researchers measure this agreement with Cohen’s kappa and percent agreement. The studies also examine the safety and performance of the investigational panel device and its allergens.
Trial overview
Two records describe the same clinical trial, NCT04500834, which studied GOLD SODIUM THIOSULFATE as part of a metal panel patch test. The trial aimed to evaluate the diagnostic efficacy, safety, and overall performance of the investigational allergens and panel device.
Who was studied
The trial targeted people with allergic contact dermatitis, and one record also listed eczema as a condition under study. These are skin conditions where the skin reacts to something it touches.
The study does not give detailed participant rules in the provided data, but it clearly focused on people being tested for possible metal allergy.
What was tested
The intervention list included a gold allergen named gold sodium thiosulfate (GST) 2.0%, given for cutaneous use, which means use on the skin. It was part of a broader metal panel that also included nickel, copper, tin, manganese, ammonium, zinc, sodium, cobalt, vanadium, and potassium dichromate allergens.
The study compared a hydrogel investigational allergen with a petrolatum reference allergen, which means the researchers were checking whether two patch testing methods gave similar results.
Study phase and design
This was an interventional study, meaning the researchers actively used the patch test and then observed the results. Both records list the study as Phase 3, which usually means the test is being checked in a larger group of people to learn more about how well it performs.
One record shows the status as Withdrawn, while the other shows Authorised. The provided data do not explain why the status differs.
Main endpoints
The primary outcome was concordance, which means agreement, between the hydrogel patch test and the petrolatum patch test. This agreement was measured with Cohen’s kappa, a statistic that shows how closely two methods match, and with positive and negative percent agreement.
The brief summary says the study also looked at diagnostic efficacy and safety of the investigational allergens, plus the safety and performance of the panel device component.
Trial status and size
The withdrawn record lists an enrollment of 300 participants, while the authorised record lists an enrollment of 395 participants. Because the same NCT number appears twice, these records likely describe different registry entries or updates for the same study.
In simple terms, the trial tried to learn whether GOLD SODIUM THIOSULFATE could help identify metal allergy in a reliable way, while also checking safety and test performance.