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GOLD SODIUM THIOSULFATE

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.

Table of contents

Trial overview

Two records describe the same clinical trial, NCT04500834, which studied GOLD SODIUM THIOSULFATE as part of a metal panel patch test.[1][1] The trial aimed to evaluate the diagnostic efficacy, safety, and overall performance of the investigational allergens and panel device.[1][1]

Who was studied

The trial targeted people with allergic contact dermatitis, and one record also listed eczema as a condition under study.[1][1] 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.[1][1]

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.[1][1] It was part of a broader metal panel that also included nickel, copper, tin, manganese, ammonium, zinc, sodium, cobalt, vanadium, and potassium dichromate allergens.[1][1]

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.[1][1]

Study phase and design

This was an interventional study, meaning the researchers actively used the patch test and then observed the results.[1][1] 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.[1][1]

One record shows the status as Withdrawn, while the other shows Authorised.[1][1] The provided data do not explain why the status differs.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.[1][1] This agreement was measured with Cohen’s kappa, a statistic that shows how closely two methods match, and with positive and negative percent agreement.[1][1]

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.[1][1]

Trial status and size

The withdrawn record lists an enrollment of 300 participants, while the authorised record lists an enrollment of 395 participants.[1][1] Because the same NCT number appears twice, these records likely describe different registry entries or updates for the same study.[1][1]

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.[1][1]

Trial ID Phase Condition studied Status Enrollment
NCT04500834 Phase 3 Allergic contact dermatitis, eczema Withdrawn 300
NCT04500834 Phase 3 Allergic contact dermatitis Authorised 395

FAQ

  • What are clinical trials of GOLD SODIUM THIOSULFATE studying? They are studying GOLD SODIUM THIOSULFATE as part of metal panel patch testing. The main goal is to see how well the test detects allergy and how safe the testing method is.
  • Who can take part in these trials? The trials focus on people with allergic contact dermatitis, and one trial also includes eczema. These are skin conditions that can happen when the skin reacts to something it is sensitive to.
  • What phase are these trials? The trials are Phase 3 studies. Phase 3 usually means the test is being studied in a larger group of people to check performance and safety.
  • What outcome is being measured? The main outcome is concordance, which means agreement, between two patch testing methods. The study uses Cohen’s kappa and percent agreement to compare results.
  • What is being compared in the studies? The studies compare a hydrogel investigational allergen with a petrolatum reference allergen. This helps researchers see whether the newer method gives results similar to the standard method.

Ongoing Clinical Trials on GOLD SODIUM THIOSULFATE

  • Study on the Safety and Effectiveness of Metal Panel Allergens for Patients with Allergic Contact Dermatitis

    Recruiting

    1 1 1 1
    Investigated drugs:
    Germany Italy The Netherlands

  • Study on the Safety and Effectiveness of Metal Panel Allergens for Diagnosing Allergic Contact Dermatitis and Eczema in Patients

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany Italy The Netherlands

Glossary

  • Allergic contact dermatitis: A skin rash caused when the skin touches something it is allergic to.
  • Eczema: A common skin condition that can cause dry, itchy, and inflamed skin.
  • Patch test: A skin test where small amounts of substances are placed on the skin to see if they cause a reaction.
  • Metal panel: A group of metal allergens tested together to find which metal may trigger a skin allergy.
  • Allergen: A substance that can cause an allergic reaction in some people.
  • Interventional study: A clinical trial where researchers actively give a test or treatment and observe the results.
  • Phase 3: A later stage of clinical research that studies the test or treatment in a larger group of people.
  • Cohen’s kappa: A statistical measure used to show how much two test methods agree with each other.
  • Positive percent agreement: A measure of how often two methods both give a positive result.
  • Negative percent agreement: A measure of how often two methods both give a negative result.

References