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Metal Allergen Patch Test for Eczema

Phase 3

Recruiting

Research Sponsored by Allerderm

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years of age or older

Be older than 18 years old

Must not have

Acute dermatitis outbreak or dermatitis on or near the test area on the back

Known or suspected infection of the skin, joints or other site(s) associated with metal exposure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up days 3-21

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial tests if metal allergens cause skin reactions in people.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include skin irritation at the site of the patch test, itching, redness, and possibly triggering an eczema flare-up if there's an allergic reaction to one of the metals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

Select...

I might have an infection related to metal exposure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 3-21

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days 3-21

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 3-21 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with positive, negative, irritant or doubtful patch test responses and concordance between hydrogel and petrolatum allergens

Secondary study objectives

Evaluation of chip irritation

Evaluation of panel adhesion at visit 2 prior to panel removal

Evaluation of subject reported burning associated with test panels at visit 2 following panel removal.

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

0 / 3Eligibility criteria met