Nickel sulfate hexahydrate

Nickel sulfate hexahydrate, also written as Nickel(II)-sulfat, 6*H2O, is a chemical substance used in diagnostic testing for allergic contact dermatitis. It is applied to the skin as part of a patch test to identify whether a person has an allergic reaction to nickel. The substance is not a treatment but a diagnostic tool used by healthcare professionals.

What is nickel sulfate hexahydrate?

Nickel sulfate hexahydrate is a chemical compound that contains nickel, a metal commonly found in everyday items such as jewelry, coins, and metal tools. In the clinical trial records, it is listed as a test substance prepared as a 5% test ointment for cutaneous use. The substance is used to provoke a localised skin reaction in people who may be allergic to nickel, helping to confirm a diagnosis of allergic contact dermatitis.

How does nickel sulfate hexahydrate work?

When nickel sulfate hexahydrate is applied to the skin under a patch, it can trigger an immune response in people who are sensitised to nickel. This response appears as a local skin reaction, such as redness or a rash, at the application site. The reaction indicates that the person's immune system recognises nickel as a foreign substance. This mechanism is the basis for patch testing, which is a standard method for diagnosing contact allergies.

Which conditions is it used or studied for?

• Allergic contact dermatitis — a skin condition caused by direct contact with an allergen, leading to redness, itching, and rash.
• Eczema — a broader term for skin inflammation that can have various triggers, including contact allergens like nickel.

How is nickel sulfate hexahydrate given?

Nickel sulfate hexahydrate is given by cutaneous use, meaning it is applied directly to the skin. In the trial, it was prepared as a 5% test ointment and applied in a volume of 20 microlitres. The substance is part of a metal panel that includes other potential allergens such as copper, tin, manganese, zinc, gold, cobalt, vanadium, and chromium compounds. These are applied to the skin to test for allergic reactions to various metals.

What do the clinical trials show?

The clinical trial data includes two records for a Phase 3 interventional study titled "Metal Panel Patch Test". One record has the status "Withdrawn" with a planned enrollment of 300 participants, while the other has the status "Authorised" with a planned enrollment of 395 participants. Both records list the same primary outcome: the concordance, or agreement, between the hydrogel and petrolatum patch testing methods, calculated using Cohen's kappa and positive and negative percent agreement.^[1] The study aimed to evaluate the diagnostic efficacy and safety of the investigational allergens and the overall performance of the panel device.

Who can take part in these trials?

The trial records do not provide specific eligibility criteria in the available data. The study was designed for people undergoing patch testing for allergic contact dermatitis or eczema. The planned enrollment numbers were 300 and 395 participants respectively.

What are the trials measuring?

The primary outcome measures the agreement between two patch testing methods: the investigational hydrogel and the reference petrolatum. The agreement is assessed using Cohen's kappa, a statistical measure of agreement, and by positive and negative percent agreement. This comparison helps determine whether the new hydrogel method produces results comparable to the established petrolatum method.

What side effects are known?

The available data does not include specific information about side effects from the supplementary sources. The trial records describe the evaluation of safety as part of the study objectives, but no detailed side effect data is provided in the clinical trial summaries.