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AMMONIUM TITANIUM OXALATE MONOHYDRATE

Clinical trials are investigating AMMONIUM TITANIUM OXALATE MONOHYDRATE as part of a metal panel patch test. These studies look at diagnostic performance, safety, and agreement between test methods in people with allergic contact dermatitis and eczema.

Table of contents

Trial overview

The available trial record is for Metal Panel Patch Test, a study that includes AMMONIUM TITANIUM OXALATE MONOHYDRATE as one of the allergens being tested.[1] The study is an interventional study, which means researchers are actively testing a patch test product rather than only observing people.[1]

The brief summary says the study is designed to evaluate the diagnostic efficacy and safety of the investigational allergens, as well as the overall safety and performance of the investigational panel device constituent.[1] In simple terms, the trial is asking whether the patch test works well and whether it can be used safely in the study setting.[1]

Who the trials target

The study population includes people with allergic contact dermatitis, and one record also lists eczema as a condition under study.[1] Allergic contact dermatitis means a skin reaction after contact with a substance that the skin does not tolerate well.[1]

The source data does not provide detailed inclusion or exclusion rules, so the exact participation criteria are not fully described here.[1] What is clear is that the study is focused on people being evaluated for skin allergy reactions, not on healthy volunteers.[1]

What is being tested

AMMONIUM TITANIUM OXALATE MONOHYDRATE appears in the trial data as Ammonium Allergen and is listed as ammonium titanium oxide oxalate 21% in a cutaneous use patch test.[1] The trial also includes several other metal allergens, such as nickel, copper, tin, manganese, zinc, gold, sodium, cobalt, vanadium, and potassium dichromate.[1]

The study compares a hydrogel version of the investigational allergen with a petrolatum reference allergen.[1] Hydrogel is a gel-like test base, while petrolatum is a greasy base used as the reference method in the patch test.[1]

Main outcomes and endpoints

The primary outcome is concordance, which means agreement, between the hydrogel patch test and the petrolatum patch test.[1] This agreement is measured using Cohen’s kappa, a statistic that shows how much two tests agree beyond chance, plus positive percent agreement and negative percent agreement.[1]

These measures help researchers see whether the new testing method gives results similar to the reference method when the test is positive and when it is negative.[1] The trial summary also says the study is looking at diagnostic efficacy and safety, so the endpoint focus is not only agreement but also whether the test performs well overall.[1]

Study design and phase

Both records for NCT04500834 describe the study as Phase 3.[1] Phase 3 studies usually involve more people and are used to confirm how well a test or treatment performs in a larger group.[1]

The enrollment numbers differ between the two records: one lists 300 participants and the other lists 395 participants.[1] Because the source data shows two records for the same trial ID with different status and enrollment values, the trial information should be read as presented in the source rather than as a single final dataset.[1]

Trial status and enrollment

One record for NCT04500834 is marked Withdrawn, and another is marked Authorised.[1] The source data does not explain why the status differs between the two records.[1]

The study is listed with enrollment of 300 in one record and 395 in the other.[1] For patients and families, this means the trial was planned to include a moderate number of people to compare patch test methods in a meaningful way.[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 the trials studying? They are studying a metal panel patch test that includes AMMONIUM TITANIUM OXALATE MONOHYDRATE. The main goal is to see how well the hydrogel test agrees with the reference petrolatum test.
  • Who may take part in these trials? The trials focus on people with allergic contact dermatitis, and one trial also includes people with eczema. The source data does not give more detailed participation rules.
  • What phase are these trials in? Both trials are Phase 3 studies. Phase 3 means the test is being studied in a larger group to check how well it works and how safe it is.
  • What is the main outcome being measured? The main outcome is concordance, which means agreement, between the 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 Withdrawn and one record is Authorised. Both records refer to the same study ID, NCT04500834.

Ongoing Clinical Trials on AMMONIUM TITANIUM OXALATE MONOHYDRATE

  • 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 reacts to something it has touched.
  • 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.
  • Hydrogel: A gel-like material used in one of the test methods in this study.
  • Petrolatum: A greasy base used as the reference method in the patch test.
  • Concordance: Agreement between two test methods.
  • Cohen’s kappa: A statistical measure used to show how much two tests agree beyond chance.
  • Positive percent agreement: How often both test methods give a positive result.
  • Negative percent agreement: How often both test methods give a negative result.
  • Interventional study: A study where researchers test an intervention, such as a patch test product, rather than only observing people.
  • Phase 3: A later stage of testing that usually includes more people and focuses on performance and safety.

References