Not yet recruiting

Study on the Safety and Effectiveness of Metal Panel Allergens for Diagnosing Allergic Contact Dermatitis and Eczema in Patients

Fast replyRegistered drug

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the safety and effectiveness of a group of substances known as Metal Panel Allergens. These substances are used to test for allergic contact dermatitis, a type of skin reaction that occurs when the skin comes into contact with certain metals. The study will use a special patch test to apply these allergens to the skin. The allergens being tested include Nickel Sulfate, Copper Sulfate, Tin Chloride, Manganese Chloride, Zinc Chloride, Cobalt Chloride, Gold Sodium Thiosulfate, Sodium Tetrachloropalladate, Vanadium Oxide Sulfate, Ammonium Titanium Oxalate, and Potassium Dichromate. These substances are applied to the skin using a device called the allergEAZE Patch Test Chamber, which helps to deliver the allergens in a controlled manner.

The purpose of the study is to evaluate how well these allergens can diagnose allergic contact dermatitis and to ensure they are safe to use. Participants will have the allergens applied to their skin in the form of patches, which will remain in place for a short period. The study will monitor any skin reactions that occur, which can help determine if a person is allergic to any of the metals tested. The study will also compare the results of this patch test method with a reference method to see how well they agree.

The trial will take place over a period of time, with participants being monitored for any reactions to the allergens. The study aims to provide valuable information on the safety and performance of these metal allergens in diagnosing allergic contact dermatitis. This information could help improve the way allergies to metals are diagnosed and managed in the future.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
Upon joining the study, you will attend an initial visit where the study procedures will be explained. You will be asked to sign an informed consent form, confirming your understanding and agreement to participate.
During this visit, your medical history will be reviewed to ensure you meet the study's eligibility criteria. This includes confirming any history of allergic contact dermatitis or metal allergies.
Step 2
Patch application
You will receive a series of cutaneous patches containing different metal allergens. These patches will be applied to your skin, typically on your back, to test for allergic reactions.
The patches contain various substances such as nickel sulfate hexahydrate, copper sulfate, stannous chloride, and others. Each patch is designed to test for a specific metal allergy.
Step 3
Patch removal
After a specified period, usually 48 hours, you will return to the clinic for the removal of the patches. This allows the study team to observe any immediate reactions to the allergens.
Step 4
Initial assessment
Following the removal of the patches, an initial assessment of your skin will be conducted. The study team will check for any signs of an allergic reaction, such as redness or swelling.
Step 5
Follow-up assessment
A follow-up assessment will occur 72 to 96 hours after the initial patch application. This is to observe any delayed reactions that may occur after the patches have been removed.
Step 6
Final evaluation
A final evaluation will be conducted to assess the overall response to the patch test. The study team will discuss the results with you and provide any necessary recommendations based on your reactions.

Who can join the trial?

7 criteria

Must be 18 years of age or older.
For Group 1: Must have active skin inflammation (dermatitis) suspected to be caused by an allergy to metals, or have had such a condition in the past 5 years that improved with treatment or avoiding the metal. This group may include people who had a positive skin test for metal allergy in the last 10 years or have a metal implant.
For Group 2: Must have no history or symptoms of skin inflammation related to dermatitis.
For Group 2: Must not have any past or current body piercings, dental work like braces or fillings, implants, prosthetics, surgical hardware, or any metal implants.
For Group 2: Must not have regular or long-term exposure to metals at work or in daily life.
If female and able to become pregnant, must be unable to become pregnant or agree to use a reliable method of birth control.
Must understand and sign the approved Informed Consent form, which is a document explaining the study and agreeing to participate.

Who cannot join the trial?

2 criteria

Patients with **allergic contact dermatitis** cannot participate. This is a skin reaction that occurs when the skin comes into contact with a substance that causes an allergic response.
Patients with **eczema** are not eligible. Eczema is a condition that makes the skin red, inflamed, and itchy.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Amsterdam UMC
Amsterdam, The Netherlands
Verified
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, Italy
Responsive
Ludwig Maximilian University Of Munich
Munich, Germany

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Metal Panel Allergens are substances used in this clinical trial to test for allergies. These allergens are small amounts of metals that are applied to the skin to see if they cause an allergic reaction. The purpose of using these allergens is to help identify if a person is allergic to certain metals, which can be important for people who might come into contact with metals in their daily life or work. The trial aims to ensure that these allergens are safe to use and effective in diagnosing metal allergies.

What is already known about the treatment

Metal Panel Allergens – This medication is administered through a patch test applied to the skin, which helps diagnose allergic contact dermatitis and eczema. Currently, it is being evaluated in clinical trials to determine its safety and effectiveness in diagnosing these conditions. The main therapeutic indication is to identify specific metal allergens that may cause skin reactions. At the molecular level, the allergens in the panel interact with the immune system, triggering a response that can be observed as a skin reaction. This medication falls under the pharmacological classification of diagnostic agents used in allergy testing.

Investigated diseases

Allergic contact dermatitis
Allergic contact dermatitis is a skin condition that occurs when the skin comes into contact with a substance that triggers an allergic reaction. The skin becomes red, inflamed, and itchy, often developing blisters or rashes. This condition progresses as the immune system reacts to the allergen, causing symptoms to appear within a few hours to a few days after exposure. The severity of the reaction can vary depending on the individual's sensitivity and the amount of exposure to the allergen. Over time, repeated exposure can lead to chronic skin changes, such as thickening or scaling. Avoiding the allergen is crucial to prevent further reactions.
Eczema
Eczema, also known as atopic dermatitis, is a chronic skin condition characterized by dry, itchy, and inflamed skin. It often begins in childhood and can persist into adulthood, with periods of flare-ups and remissions. The skin may become red, cracked, and prone to infection during flare-ups. Eczema is believed to be caused by a combination of genetic and environmental factors, leading to a compromised skin barrier. The condition can progress with persistent itching and scratching, which may cause the skin to thicken and become more susceptible to irritation. Managing triggers and maintaining skin hydration are important to control symptoms.