Europas førende søgning efter kliniske forsøg

AMMONIUM TITANIUM OXALATE MONOHYDRATE

Clinical trials are studying AMMONIUM TITANIUM OXALATE MONOHYDRATE as part of a metal panel patch test. These studies look at how well the test works and how safe it is in people with allergic contact dermatitis, and one trial also includes eczema.

Table of contents

Overview of the trials

These clinical trials study AMMONIUM TITANIUM OXALATE MONOHYDRATE as part of a metal panel patch test for people with skin allergy problems.[1] The studies are looking at whether the test works well and whether it is safe to use in the study setting.[1]

The trial records describe the project as an interventional study, which means the researchers actively give the test substances and then measure the results.[1]

Who the trials are for

The main condition studied is allergic contact dermatitis, which is a skin reaction caused by contact with something a person is allergic to.[1] One trial record also includes eczema as a condition.[1]

These records do not give full inclusion or exclusion rules, so the available data only show the broad target population, not all participation details.[1]

What is being tested

AMMONIUM TITANIUM OXALATE MONOHYDRATE is listed in the trial data as an ammonium allergen within the metal panel.[1] It is tested together with other metal-related allergens such as nickel, copper, tin, manganese, zinc, gold, sodium, vanadium, cobalt, and chromium-related test substances.[1]

The study compares a hydrogel version of the investigational allergen with a petrolatum version used as the reference method.[1] Petrolatum is a soft ointment base used here as the comparison standard.[1]

Main outcomes and how they are measured

The main outcome is concordance, which means agreement between the two patch testing methods.[1] The researchers measure this agreement with Cohen’s kappa, a statistic that shows how much two methods agree beyond chance.[1]

They also measure positive percent agreement and negative percent agreement, which show how often the two methods match when the result is positive or negative.[1] These measures help show whether the investigational patch test performs similarly to the reference method.[1]

The brief study summary says the goal is to evaluate the diagnostic efficacy and safety of the investigational allergens, as well as the overall safety and performance of the panel device component.[1] Diagnostic efficacy means how well a test can identify the condition or allergy being studied.[1]

Trial phase and study design

Both records are listed as Phase 3 studies.[1] Phase 3 studies are usually larger studies that help researchers learn more about how well a test or treatment performs in a bigger group of people.[1]

The trial data describe the studies as interventional, meaning the test substances are applied as part of the research plan rather than only being observed in routine care.[1]

Trial status and enrollment

The records show two status entries for the same trial ID, NCT04500834: one is Withdrawn and one is Authorised.[1] The data provided do not explain why the status differs between the two records.[1]

The enrollment numbers listed are 300 in one record and 395 in the other.[1] Enrollment means the planned number of participants in the study.[1]

Key points for patients

  • The trials focus on skin allergy testing, not on treating the allergy itself.[1]

  • AMMONIUM TITANIUM OXALATE MONOHYDRATE is one part of a larger metal panel used in patch testing.[1]

  • The main question is whether the investigational test agrees with a standard comparison method.[1]

  • The studies include people with allergic contact dermatitis, and one record also includes eczema.[1]

  • Both records are Phase 3, so they are focused on performance and safety in a larger study setting.[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 is being studied in these trials? The trials study AMMONIUM TITANIUM OXALATE MONOHYDRATE as one part of a metal panel patch test. The main goal is to see how well the test agrees with a reference method.
  • Who can take part in the studies? The target populations are people with allergic contact dermatitis, and one trial also includes people with eczema. The trial data do not give more detailed entry rules.
  • What phase are these trials? Both trials are Phase 3 studies. This means they are testing the method in a larger group to learn more about performance and safety.
  • What outcome are the researchers measuring? The main outcome is concordance, which means agreement, between two patch testing methods. The study uses Cohen’s kappa and positive and negative percent agreement to measure this.
  • What is the status of the trials? One record is listed as Withdrawn and another as Authorised. Both records have the same trial ID, NCT04500834.

Igangværende kliniske forsøg for AMMONIUM TITANIUM OXALATE MONOHYDRATE

  • Test af metalallergi hos personer med allergisk kontakteksem ved hjælp af lappetest

    Rekrutterer

    1 1 1 1
    Undersøgte lægemidler:
    Tyskland Italien Holland

  • Test af nyt metal-panel til diagnose af kontaktallergi og eksem

    Rekrutterer endnu ikke

    1 1 1 1
    Undersøgte sygdomme:
    Undersøgte lægemidler:
    Tyskland Italien Holland

Ordliste

  • Allergic contact dermatitis: A skin reaction that happens 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 check for allergy.
  • Metal panel: A group of different metal-related test substances used together in one test panel.
  • Investigational allergen: A test substance being studied to see how well it identifies allergy.
  • Reference allergen: The standard method used for comparison in a study.
  • Concordance: Agreement between two test methods.
  • Cohen’s kappa: A statistic used to measure how much two test results agree, beyond chance.
  • Positive percent agreement: How often both methods agree when the test result is positive.
  • Negative percent agreement: How often both methods agree when the test result is negative.
  • Phase 3: A later study phase that usually tests a method in a larger group of people.

Referencer

  1. https://kliniske-forsoeg.dk/forsog/test-af-nyt-metal-panel-til-diagnose-af-kontaktallergi-og-eksem/
  2. https://kliniske-forsoeg.dk/forsog/test-af-metalallergi-hos-personer-med-allergisk-kontakteksem-ved-hjaelp-af-lappetest/