Metal Allergen Patch Test for Eczema

Overseen By Kathryn Shannon

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Allerderm

Must not be taking: Corticosteroids, Immunosuppressants

Disqualifiers: Pregnancy, Breastfeeding, Psoriasis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a metal allergen patch to better understand and treat eczema triggered by metal allergies. Researchers will apply patches containing various metal allergens to participants to identify reactions, helping to pinpoint those prone to metal-triggered skin issues. This trial is particularly useful for individuals who have had positive patch test results for metal allergies (excluding nickel or gold) in the past decade or suspect a metal contact allergy. The patch test used in this trial is the Metal Panel T.R.U.E. Test (Thin-layer Rapid Use Epicutaneous Patch Test). As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

You may need to stop using certain medications. Specifically, you cannot use topical or systemic corticosteroids (a type of medication that reduces inflammation) or other immunosuppressive agents for 14 days before and during the study. However, inhaled treatments and steroidal nose or eye drops are allowed.

Is there any evidence suggesting that the Metal Panel T.R.U.E. Test is likely to be safe for humans?

Research has shown that the Metal Panel T.R.U.E. Test is generally easy for most people to handle. This test identifies substances that might cause allergic skin reactions, known as allergic contact dermatitis.

Studies have found the T.R.U.E. Test to be safe, with only a few possible issues. These include increased skin irritation, the development of a new allergy from the test, and, very rarely, a serious allergic reaction like anaphylaxis. However, these problems are uncommon.

The T.R.U.E. Test, a ready-to-use patch test, has been widely used and studied. It is designed for comfort, making it a reliable choice for those considering testing for eczema. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for eczema, which often focus on topical creams or systemic medications to manage symptoms, the Metal Panel T.R.U.E. Test offers a diagnostic approach aimed at identifying specific metal allergens that may trigger eczema flare-ups. This patch test is unique because it evaluates reactions to 11 experimental and 11 reference allergens, providing a more comprehensive understanding of potential triggers. By pinpointing specific metal allergies, this test could lead to personalized treatment plans and better management of eczema, which is why researchers are eager to explore its potential benefits.

What evidence suggests that the Metal Panel T.R.U.E. Test is effective for eczema?

Research has shown that the Metal Panel T.R.U.E. Test, which participants in this trial will undergo, effectively identifies metal allergies, aiding in the management of conditions like eczema. Studies have demonstrated that this test reliably diagnoses allergic contact dermatitis, a common cause of eczema. The T.R.U.E. Test is simple to use and provides accurate results with few side effects. Identifying specific metal allergies allows for more customized treatments to reduce eczema symptoms. Overall, the test is recognized as a trusted method for identifying allergies that might trigger eczema flare-ups. ^{1 3 6 7 8}

Who Is on the Research Team?

Curt Hamann, M.D.

Principal Investigator

Allerderm (dba SmartPractice)

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a past positive patch test to certain metals or strong suspicion of metal allergy. They must be able to follow the study plan, not be pregnant or breastfeeding, and willing to use contraception if necessary. People using certain medications or treatments, those with skin infections, acute dermatitis near the test area, or other conditions that might affect results can't join.

Inclusion Criteria

I cannot become pregnant or am willing to use birth control.

Understands and signs the approved Informed Consent form which is consistent with all institutional, local and national regulations

You have tested positive for an allergy to certain metals in the past 10 years, or you are strongly suspected to have an allergy to metals based on a questionnaire.

Exclusion Criteria

I experience symptoms like chronic fatigue or headaches not linked to metal exposure.

I have a skin rash or irritation on or near my back.

Inability to comply with patch test study requirements including multiple return visits and activity restrictions (e.g., protecting test panels from excess moisture due to showering or vigorous activity)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Patch Application

A single application of an investigational patch test panel containing 11 hydrogel metal allergens and a corresponding patch test panel containing 11 petrolatum metal allergens will be applied to the upper back of human subjects

2 days

1 visit (in-person)

Patch Removal and Evaluation

Patch test panels will be removed after being worn for approximately 48 hours, followed by evaluation visits

19 days

5 visits (in-person) on days 4, 7, 14, and 21

Follow-up

Participants are monitored for safety and effectiveness after patch removal

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Metal Panel T.R.U.E. Test

Trial Overview The Metal Panel T.R.U.E. Test is being studied in this trial. It's a patch test designed to identify allergies to specific metals in people who have had reactions before or are suspected of having metal contact allergies.

How Is the Trial Designed?

Group I: Positive reactions, Concordance with reference allergen Experimental Treatment 1 Intervention

All subjects will be patch tested with 11 experimental and 11 reference allergens. Rates of positive reactions will be evaluated using Cohen's kappa calculation.

Who Is Running the Clinical Trial?

Allerderm

Lead Sponsor

Trials

11

Recruited

970+

Published Research Related to This Trial

In patients with atopic eczema, positive reactions to aeroallergens (like dust mites and pollen) significantly increased transepidermal water loss (TEWL), indicating a compromised skin barrier, compared to control sites.

In contrast, positive reactions to contact allergens (like nickel and potassium dichromate) did not show a significant change in TEWL, suggesting that the skin barrier is only altered in response to aeroallergens, which may lead to worsening eczema symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The disturbance of epidermal barrier function in atopy patch test reactions in atopic eczema. Gfesser, M., Rakoski, J., Ring, J.[2004]

The study found that while nickel(II) sulfate and formaldehyde concentrations in patch test preparations were at or above their labeled amounts, formaldehyde levels decreased over time due to storage conditions.

Methyl methacrylate and glutaraldehyde concentrations were significantly lower than labeled amounts, with methyl methacrylate showing a loss of potency due to its volatility, which could lead to false-negative test results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concentrations and stability of methyl methacrylate, glutaraldehyde, formaldehyde and nickel sulfate in commercial patch test allergen preparations. Siegel, PD., Fowler, JF., Law, BF., et al.[2021]

During a six-year study involving 6341 patients, 65% were diagnosed with contact allergic dermatitis using standard patch tests, highlighting the test's efficacy in identifying contact allergies.

The study revealed an increased frequency of positive reactions to certain allergens like potassium dichromate and nickel sulfate, while reactions to others like cobalt chloride and rubber mixtures decreased, indicating changing trends in contact allergies that should be monitored.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective survey of patch testing at department of dermatology and venerology, zagreb university hospital center in zagreb, croatia. Marinović-Kulisić, S., Lipozencić, J., Ljubojević, S., et al.[2011]

The atopy patch test (APT) can induce eczematous skin reactions in 30-70% of patients with atopic eczema, suggesting a significant role of IgE-inducing allergens in exacerbating the condition.

Patients with specific eczema patterns, a history of allergic reactions, and elevated specific IgE levels are more likely to have positive APT results, indicating that targeted allergen avoidance strategies may be beneficial for these individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Allergy and atopic eczema: on the value of the "atopy patch test"]. Darsow, U., Abeck, D., Ring, J.[2019]

The TRUE-test is a new patch test that uses a thin, flexible solid vehicle to deliver allergens, improving stability and bioavailability compared to traditional petrolatum-based tests.

This innovative approach ensures precise dosage and even surface spread of allergens, addressing common issues like low bioavailability and uneven distribution seen in older testing methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The thin layer rapid use epicutaneous test (TRUE-test), a new patch test method with high accuracy. Fischer, TI., Maibach, HI.[2019]

In a study of 1,112 patients suspected of metal allergies, patch testing revealed that 57% had at least one positive reaction, with nickel and gold being the most common allergens.

Testing with additional metal allergens beyond the standard series identified several metals, such as manganese and palladium, that also caused allergic reactions, highlighting the need for tailored testing in certain patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patch testing with a large series of metal allergens: findings from more than 1,000 patients in one decade at Mayo Clinic. Davis, MD., Wang, MZ., Yiannias, JA., et al.[2015]

In a study of 57 patients with atopic eczema, those with a predictive lesional pattern (group I) showed a higher rate of positive reactions to the atopy patch test (69%) compared to those without this pattern (group II, 39%), indicating increased sensitivity to aeroallergens.

Patients in group I also reacted to lower concentrations of allergens, suggesting that their skin is more reactive to environmental triggers, which could help in tailoring more effective management strategies for atopic eczema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The atopy patch test: an increased rate of reactivity in patients who have an air-exposed pattern of atopic eczema. Darsow, U., Vieluf, D., Ring, J.[2006]

The T.R.U.E. Test, a widely used patch test for allergic contact dermatitis, identified nickel, thimerosal, and cobalt as the most prevalent allergens among over 3700 tested, with nickel being the most common at 14.7% of patients showing positive reactions.

Despite its utility, the T.R.U.E. Test only screens for 23 allergens, which may lead to missing clinically significant allergens, as indicated by comparisons with the North American Contact Dermatitis Data Group data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence and relevance of contact dermatitis allergens: a meta-analysis of 15 years of published T.R.U.E. test data. Krob, HA., Fleischer, AB., D'Agostino, R., et al.[2022]

Citations

1. fda.gov fda.gov/media/83084/download

Package Insert - TRUE TEST Thin-layer Rapid Use Epicutaneous Patch Test, T.R.U.E. TEST, is a ready-to-use allergen patch test. 303 system consisting of 35 allergen and allergen mix ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0738081X2100050X

Patch testing: Uses, systems, risks/benefits, and its role in ... Patch testing is the gold standard diagnostic tool for cell-mediated type IV hypersensitivity reactions like allergic contact dermatitis.

3. ijdvl.com ijdvl.com/thin-layer-rapid-use-epicutaneous-test-true-test/

Thin-layer rapid-use epicutaneous test (TRUE test) Studies have shown that TRUE test is a well standardized technique of patch testing; it is easy to handle, with few side effects and gives good accuracy.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/21781636/

Safety and efficacy evaluation of TRUE TEST panels 1.1, ... To evaluate the efficacy and safety of TRUE Test panels 1.1, 2.1, and 3.1 in children and adolescents suspected of having allergic contact dermatitis (ACD).

5. smartpractice.com smartpractice.com/shop/category?id=508222&m=SPA&srsltid=AfmBOool-H-EXRlhdKzH_W1mXPwaSkLtiAEZJnr2v2JaOaXuYkuqFCtw

T.R.U.E. TEST Ready-to-Use Patch Test Panels TRUE TEST is a convenient, ready-to-use patch test for the diagnosis of allergic contact dermatitis. Patch testing is a simple procedure to help diagnose ...

6. smartpractice.com smartpractice.com/shop/category?id=508222&m=SPA&srsltid=AfmBOoqYlP-y8fvljo_K5jPYduNlr6vbIFDBCjkulkesamv5uuci7hJB

T.R.U.E. TEST Ready-to-Use Patch Test Panels TRUE TEST is a convenient, ready-to-use patch test for the diagnosis of allergic contact dermatitis. Patch testing is a simple procedure to help diagnose ...

7. fda.gov fda.gov/media/107666/download

Clinical Review - T.R.U.E. TEST Established Name Thin-layer Rapid Use Epicutaneous. Patch Test ... o T.R.U.E. TEST is an epicutaneous patch test indicated for use as an aid.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6170075/

Contact Dermatitis, Patch Testing, and Allergen Avoidance The T.R.U.E. (Thin-layer Rapid-Use Epicutaneous) Test is a pre-made patch test that consists of 35 allergens incorporated into hydrophilic gels. The T.R.U.E. ...