Metal Allergen Patch Test for Eczema
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Allerderm
Must not be taking: Corticosteroids, Immunosuppressants
Disqualifiers: Pregnancy, Breastfeeding, Psoriasis, others
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 2 Jurisdictions
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.12345
Is the Metal Allergen Patch Test for Eczema safe for humans?
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.12458
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.
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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)
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Trial 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 (Allergen Patch Test)
Trial OverviewThe 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
1Treatment groups
Experimental Treatment
Group I: Positive reactions, Concordance with reference allergenExperimental Treatment1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
DS ResearchLouisville, KY
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Who Is Running the Clinical Trial?
AllerdermLead Sponsor
References
The disturbance of epidermal barrier function in atopy patch test reactions in atopic eczema. [2004]Atopic eczema (AE) is a common skin disorder. Eczematous lesions showing macroscopic, microscopic and immunopathological resemblance to lesional AE can be induced by aeroallergens by epicutaneous testing (atopy patch test, APT). Altered epidermal barrier function, as determined by transepidermal water loss (TEWL), is a typical feature of patients with AE. The present investigation was performed to define the differences in the epidermal barrier function between positive APT reactions to aeroallergens and positive patch test reactions to contact allergens in AE patients. Allergen extracts from grass pollen, birch pollen, cat dander and house dust mite (Dermatophagoides pteronyssinus) were applied in large Finn chambers on Scanpor for 48 h on the clinically unaffected and untreated skin of the back, in 11 patients with AE. The same procedure was done with 27 contact allergens of a standard test battery. Test reactions were read and TEWL was measured after 48 and 72 h. Eight of the 11 patients developed positive APT reactions to D. pteronyssinus, two to cat dander and one to birch pollen. Seven of the 11 patients showed positive patch test reactions to nickel sulphate, two to potassium dichromate, one to thiuram-mix and one to paraphenylenediamine. Vehicle controls were negative. The TEWL of the positive APT reactions was significantly higher, both after 48 h (mean +/- standard deviation 10.0 +/- 6.5 g/m2h) and after 72 h (9.7 +/- 5.4 g/m2h) as compared with the control site (48/72h: 4.4 +/- 1.5/4.1 +/- 1.4 g/m2h) (P
The atopy patch test: an increased rate of reactivity in patients who have an air-exposed pattern of atopic eczema. [2006]In a subgroup of patients with atopic eczema (AE), eczematous skin lesions can be induced by epicutaneous testing with aeroallergens (the atopy patch test: APT). An increased frequency of positive APT has been found in AE patients showing a predictive lesional pattern affecting air-exposed skin areas. This study investigates the dose-response of the APT in two different patient groups with AE. Petrolatum preparations of house dust mite, cat dander and grass pollen allergens in four concentrations (500-10,000 protein nitrogen units) were tested epicutaneously in 57 patients with AE, who were prospectively divided in two groups according to whether their AE pattern was with (group I) or without (group II) a predictive distribution. Sixty-nine per cent of patients in group I, and 39% in group II, had positive APT reactions (P = 0.02). The reactions in group I were elicitable with lower allergen concentrations (P = 0.03). A clinically recognizable subgroup of patients with AE showed increased cutaneous sensitivity to aeroallergens.
Concentrations and stability of methyl methacrylate, glutaraldehyde, formaldehyde and nickel sulfate in commercial patch test allergen preparations. [2021]Epicutaneous patch tests are used to reproduce allergy and diagnose allergic contact dermatitis. Reliable allergen test preparations are required.
The thin layer rapid use epicutaneous test (TRUE-test), a new patch test method with high accuracy. [2019]The thin layer rapid use epicutaneous test (TRUE-test) is a new patch test, in which the allergens are incorporated in a thin, flexible solid vehicle on a water impermeable backing. The vehicle shows good stability for allergens, which are crystallized, micronized or emulsified into a gel. The TRUE-test produces an exact dosage, even surface spread and high bioavailability for the allergens. This solves the problems of low bioavailability, uncertain dosage and uneven surface distribution which are commonly seen when petrolatum is used as the vehicle.
[Allergy and atopic eczema: on the value of the "atopy patch test"]. [2019]The role of allergic reactions in eliciting and maintaining atopic eczema (AE) is still controversial. In a subgroup of patients with atopic eczema, exacerbations of itching and eczematous skin lesions have been described after contract with aeroallergens. To investigate this observation, an epicutaneous patch test with IgE-inducing allergens (atopy patch test, APT) has been proposed, which results in eczematous skin reactions in 30-70% of AE patients. Usage of allergen concentrations exceeding 5000 PNU/g in petrolatum allows testing on clinically uninvolved skin without potentially irritating epidermal tape stripping. The clinical relevance of positive APT reactions is suggested by comparison of APT with skin prick test, specific IgE, patient's history and eczema pattern. Patients with an eczema pattern with preferred localization of skin lesions in air-exposed areas, a predictive history and raised specific IgE (depending on allergen) were shown to have the highest rate of positive APT. Future controlled studies with allergen avoidance and reexposition may focus on this patient group.
Prevalence and relevance of contact dermatitis allergens: a meta-analysis of 15 years of published T.R.U.E. test data. [2022]The patch test procedure is frequently employed to help determine or confirm the cause of allergic contact dermatitis (ACD). The T.R.U.E. Test has become a global standard and is the commercially available patch test system currently used within the United States. Although many studies report T.R.U.E. Test data, none has measured the overall prevalence and relevance of reactions to the allergens tested by the T.R.U.E. Test. Our objective is to describe the prevalence and relevance of contact dermatitis allergens as tested by the T.R.U.E. Test.
Retrospective survey of patch testing at department of dermatology and venerology, zagreb university hospital center in zagreb, croatia. [2011]Epicutaneous (patch) test is a standard test to confirm contact allergy. During a six-year period (1998-2003), contact allergic dermatitis was diagnosed in 4132 (65%) of 6341 patients using standard patch test with a Croatian series of allergens according to the International Contact Dermatitis Research Group (ICDRG). The most common clinical diagnoses related to contact allergy (male; female) were contact allergic dermatitis (65.4%; 72.2%); atopic dermatitis (15.9%; 11.7%); contact irritant dermatitis (7.0%; 6.6%) and nummular eczematoid dermatitis (4.2%; 2.4%). According to occupation, positive patch test reaction was most commonly observed in workers, whereas 65% of patients showed positive reactions to one or more substances. There was an increased frequency of positive patch test reactions to potassium dichromate, nickel sulfate, thimerosal and neomycine sulfate, along with a significant decrease in the frequency of positive patch test reactions to cobalt chloride, carba mix, wood tars, detergents, parabens mixture, urushiol and rubber mixture. We strongly recommend keeping up-to-date with the epidemiology of contact allergy in Croatia.
Patch testing with a large series of metal allergens: findings from more than 1,000 patients in one decade at Mayo Clinic. [2015]The standard allergen series used in patch testing contains metals that most commonly cause allergic contact dermatitis, but testing with additional metal allergens is warranted for select patients.