In short
MANGANESE CHLORIDE TETRAHYDRATE is being studied in clinical trials as one of several metal allergens used in patch testing. These trials look at how well the test works, how safe it is, and whether results match a reference method in people with allergic contact dermatitis.
Key points
- Clinical trials of MANGANESE CHLORIDE TETRAHYDRATE are part of a metal panel patch test study. The research is focused on people with allergic contact dermatitis, and one record also includes eczema. Both records are Phase 3 studies, which means they are later-stage trials in larger groups. The main goal is to compare two patch test methods and see how well they agree. The key measurement is concordance, or agreement, using Cohen’s kappa plus positive and negative percent agreement. One record is Withdrawn and another is Authorised for the same study ID.
Trial overview
The available records describe a metal panel patch test that includes MANGANESE CHLORIDE TETRAHYDRATE as one of several metal allergens studied in people with skin allergy problems. The study is designed to evaluate diagnostic efficacy, safety, and the performance of the panel device used in testing.
Who is being studied
The target population includes people with allergic contact dermatitis, and one record also lists eczema. These conditions matter because the trial is looking at whether the patch test can help identify metal-related skin reactions in affected people.
What is being tested
MANGANESE CHLORIDE TETRAHYDRATE is included in the trial as a manganese allergen in a group of metal allergens. Other listed allergens in the panel include nickel, copper, tin, zinc, gold, sodium, vanadium, cobalt, chromium, and ammonium titanium oxide oxalate.
The test is applied by cutaneous use, which means it is used on the skin. The study compares a hydrogel-based investigational method with a petrolatum-based reference method.
Trial design and phase
Both records describe an interventional study, which means researchers actively test the patch method rather than only observing people. Both are listed as Phase 3 studies, showing that the test is being evaluated in a larger group of participants.
One record shows enrollment of 300 people, while the other shows enrollment of 395 people. The two records have the same NCT ID, NCT04500834, and describe the same metal panel patch test.
Main outcomes and endpoints
The main outcome is concordance, which means agreement between the hydrogel patch test and the petrolatum patch test. The study measures this agreement with Cohen’s kappa, a statistic that checks how much two methods agree beyond chance, and also with positive and negative percent agreement.
The brief summary states that 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. In simple terms, the trial is asking whether the patch test works well and whether the test setup is safe and reliable.
Trial status and enrollment
One record for NCT04500834 is marked Withdrawn, and the other is marked Authorised. Because both records describe the same study ID and same trial topic, they appear to be two records for the same patch test study with different status information.
The enrollment numbers differ between the two records, with 300 in one record and 395 in the other. This suggests the study information may have been updated or recorded differently across the two entries.