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MANGANESE CHLORIDE TETRAHYDRATE

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.

Table of Contents

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.[1][1] The study is designed to evaluate diagnostic efficacy, safety, and the performance of the panel device used in testing.[1][1]

Who is being studied

The target population includes people with allergic contact dermatitis, and one record also lists eczema.[1] These conditions matter because the trial is looking at whether the patch test can help identify metal-related skin reactions in affected people.[1]

What is being tested

MANGANESE CHLORIDE TETRAHYDRATE is included in the trial as a manganese allergen in a group of metal allergens.[1][1] Other listed allergens in the panel include nickel, copper, tin, zinc, gold, sodium, vanadium, cobalt, chromium, and ammonium titanium oxide oxalate.[1][1]

The test is applied by cutaneous use, which means it is used on the skin.[1][1] The study compares a hydrogel-based investigational method with a petrolatum-based reference method.[1][1]

Trial design and phase

Both records describe an interventional study, which means researchers actively test the patch method rather than only observing people.[1][1] Both are listed as Phase 3 studies, showing that the test is being evaluated in a larger group of participants.[1][1]

One record shows enrollment of 300 people, while the other shows enrollment of 395 people.[1][1] The two records have the same NCT ID, NCT04500834, and describe the same metal panel patch test.[1][1]

Main outcomes and endpoints

The main outcome is concordance, which means agreement between the hydrogel patch test and the petrolatum patch test.[1][1] 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.[1][1]

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.[1][1] In simple terms, the trial is asking whether the patch test works well and whether the test setup is safe and reliable.[1][1]

Trial status and enrollment

One record for NCT04500834 is marked Withdrawn, and the other is marked Authorised.[1][1] 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.[1][1]

The enrollment numbers differ between the two records, with 300 in one record and 395 in the other.[1][1] This suggests the study information may have been updated or recorded differently across the two entries.[1][1]

Trial IDPhaseCondition studiedStatusEnrollment
NCT04500834Phase 3Allergic contact dermatitis; eczemaWithdrawn300
NCT04500834Phase 3Allergic contact dermatitisAuthorised395

FAQ

  • What is being studied in trials of MANGANESE CHLORIDE TETRAHYDRATE? The trials study MANGANESE CHLORIDE TETRAHYDRATE as part of a metal panel patch test. Researchers want to see how well the test identifies metal allergy and how closely two patch testing methods agree.
  • Who can take part in these trials? The trials focus on people with allergic contact dermatitis, and one trial also lists eczema. These are skin conditions where the skin reacts to something it touches.
  • What phase are the trials? Both trials are Phase 3 studies. Phase 3 means the test is being studied in a larger group of people to check performance and safety.
  • What outcomes are the trials measuring? The main outcome is concordance, which means agreement, between the hydrogel patch test and the petrolatum patch test. The studies use Cohen’s kappa and positive and negative percent agreement to measure this.
  • What is the status of the trials? One record for NCT04500834 is Withdrawn, and another record for the same study is Authorised. Both records describe the same metal panel patch test.

Ongoing Clinical Trials on MANGANESE CHLORIDE TETRAHYDRATE

  • 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 reaction that happens after 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.
  • Allergen: A substance that can trigger an allergic reaction in some people.
  • Interventional study: A clinical trial where researchers actively test a product or method.
  • Phase 3: A later stage of clinical research that studies the test or treatment in a larger group of people.
  • Concordance: Agreement between two test methods.
  • Cohen’s kappa: A statistical tool used to measure how much two test methods agree beyond chance.
  • Positive percent agreement: How often two methods both find a positive result.
  • Negative percent agreement: How often two methods both find a negative result.
  • Hydrogel: A gel-like material used in one of the patch testing methods.
  • Petrolatum: A greasy base used as the reference method in the patch test.

References