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

200 Participants Needed

Trial Summary

What is the purpose of this trial?

Metal allergen patch test study.

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.

What data supports the effectiveness of the Metal Allergen Patch Test for Eczema treatment?

The TRUE-test, a type of patch test, is shown to have high accuracy and stability for allergens, which may help in diagnosing allergic reactions that can trigger eczema. Additionally, similar patch tests have been effective in identifying allergens that cause skin reactions in patients with atopic eczema, suggesting potential usefulness in managing eczema symptoms. ^{1 2 3 4 5}

Is the Metal Allergen Patch Test for Eczema safe for humans?

The T.R.U.E. Test, a type of patch test, is widely used and considered safe for identifying contact allergies, though some people may experience mild skin reactions at the test site. ^{1 4 5 6 7}

How does the metal allergen patch test treatment for eczema differ from other treatments?

The metal allergen patch test for eczema is unique because it involves applying metal allergens directly to the skin to identify specific triggers of allergic reactions, which can help tailor treatment to individual patients. This approach is different from standard eczema treatments that typically focus on managing symptoms with creams or medications without identifying specific allergens. ^{1 2 4 5 8}

Research Team

Curt Hamann, M.D.

Principal Investigator

Allerderm (dba SmartPractice)

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

The disturbance of epidermal barrier function in atopy patch test reactions in atopic eczema. [2004]

2. England 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. [2006]

3. England pubmed.ncbi.nlm.nih.gov

Concentrations and stability of methyl methacrylate, glutaraldehyde, formaldehyde and nickel sulfate in commercial patch test allergen preparations. [2021]

4. England pubmed.ncbi.nlm.nih.gov

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

5. Germany pubmed.ncbi.nlm.nih.gov

[Allergy and atopic eczema: on the value of the "atopy patch test"]. [2019]

6. United States 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. [2022]

7. Croatia pubmed.ncbi.nlm.nih.gov

Retrospective survey of patch testing at department of dermatology and venerology, zagreb university hospital center in zagreb, croatia. [2011]

8. United States 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. [2015]