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Study on the Safety and Effectiveness of Metal Panel Allergens for Patients with Allergic Contact Dermatitis

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What is this trial about?

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

This clinical trial is focused on studying allergic contact dermatitis, a skin condition that occurs when the skin reacts to certain substances, often metals. The study will use a variety of substances applied to the skin in the form of patches to see if they cause a reaction. These substances include copper sulfate, stannous chloride, zinc chloride, cobalt chloride, gold sodium thiosulfate, sodium tetrachloropalladate, vanadium oxide sulfate, ammonium titanium oxalate, nickel sulfate, manganese chloride, and potassium dichromate. The purpose of the study is to evaluate the safety and effectiveness of these substances in diagnosing allergic contact dermatitis.

Participants in the study will have patches containing these substances applied to their skin. The patches will remain in place for a short period, and the skin will be observed for any reactions. This process helps determine if a person is allergic to any of the metals tested. The study will also use a placebo patch for comparison. The trial aims to ensure that the patches are safe and perform well in identifying allergies.

The study will take place over a few days, with participants visiting the clinic for patch application and follow-up checks. The results will help improve understanding of how these metal allergens affect people with suspected metal allergies and contribute to better diagnostic methods for allergic contact dermatitis.

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, usually on your back, to test for allergic reactions.
The patches contain substances such as copper sulfate, stannous chloride, sodium tetrachloropalladate, and others. Each patch is designed to test a specific metal allergen.
Step 3
Patch removal
After a specified period, typically 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
Once the patches are removed, the study team will conduct an initial assessment of your skin to check for any signs of an allergic reaction, such as redness or swelling.
Step 5
Follow-up assessment
A follow-up assessment will be scheduled approximately 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
During the final evaluation, the study team will review all findings and discuss any reactions observed. This helps determine the safety and efficacy of the metal allergens tested.

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, implants, prosthetics, surgical hardware, or metal exposure from work.
For Group 2: Must not have regular or long-term exposure to metals.
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?

4 criteria

People who do not have allergic contact dermatitis cannot participate. Allergic contact dermatitis is a skin reaction caused by contact with a substance that triggers an allergic response.
Individuals who are not within the specified age range cannot participate. The study is open to certain age groups only.
Participants must be either male or female, as the study includes both genders.
People who are considered part of a vulnerable population cannot participate. Vulnerable populations include groups that may have additional risks or require special protection in research settings.

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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

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Investigated drugs

Metal Panel Allergens are substances used in this clinical trial to test for allergic reactions. These allergens are applied to the skin to see if they cause any redness, swelling, or other signs of an allergic reaction. The purpose of using these allergens is to help identify if a person is allergic to certain metals. This can be important for people who might come into contact with metals in their daily life or work, as it helps in diagnosing metal allergies and preventing allergic reactions in the future.

What is already known about the treatment

Metal Panel Allergens – This medication is administered through a patch test applied to the skin to diagnose allergic contact dermatitis. Currently, it is being evaluated in clinical trials to determine its safety and effectiveness in diagnosing allergies to metals. The main therapeutic indication is to identify specific metal allergies in individuals with suspected allergic contact dermatitis. At the molecular level, the allergens in the panel interact with the immune system, triggering a localized skin reaction if an allergy is present. 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. This reaction causes the skin to become red, inflamed, and itchy. The affected area may develop blisters or become dry and scaly over time. The severity of the symptoms can vary depending on the level of exposure and the individual's sensitivity to the allergen. The condition typically develops hours to days after exposure to the allergen. It can persist until the allergen is removed and the skin heals.