In short
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.
Key points
- Clinical trials investigating AMMONIUM TITANIUM OXALATE MONOHYDRATE are part of a metal panel patch test study in people with allergic contact dermatitis, and one record also includes eczema. Both records are Phase 3 interventional studies. The main goal is to compare the hydrogel test with the petrolatum reference test and measure how well the two methods agree. The study also looks at diagnostic performance, safety, and overall device performance. The source data lists one record as Withdrawn and another as Authorised for the same trial ID, NCT04500834.
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. The study is an interventional study, which means researchers are actively testing a patch test product rather than only observing people.
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. In simple terms, the trial is asking whether the patch test works well and whether it can be used safely in the study setting.
Who the trials target
The study population includes people with allergic contact dermatitis, and one record also lists eczema as a condition under study. Allergic contact dermatitis means a skin reaction after contact with a substance that the skin does not tolerate well.
The source data does not provide detailed inclusion or exclusion rules, so the exact participation criteria are not fully described here. What is clear is that the study is focused on people being evaluated for skin allergy reactions, not on healthy volunteers.
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. The trial also includes several other metal allergens, such as nickel, copper, tin, manganese, zinc, gold, sodium, cobalt, vanadium, and potassium dichromate.
The study compares a hydrogel version of the investigational allergen with a petrolatum reference allergen. Hydrogel is a gel-like test base, while petrolatum is a greasy base used as the reference method in the patch test.
Main outcomes and endpoints
The primary outcome is concordance, which means agreement, between the hydrogel patch test and the petrolatum patch test. 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.
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. 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.
Study design and phase
Both records for NCT04500834 describe the study as Phase 3. Phase 3 studies usually involve more people and are used to confirm how well a test or treatment performs in a larger group.
The enrollment numbers differ between the two records: one lists 300 participants and the other lists 395 participants. 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.
Trial status and enrollment
One record for NCT04500834 is marked Withdrawn, and another is marked Authorised. The source data does not explain why the status differs between the two records.
The study is listed with enrollment of 300 in one record and 395 in the other. 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.