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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 3-21
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am 18 years old or older.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with positive, negative, irritant or doubtful patch test responses and concordance between hydrogel and petrolatum allergens
Secondary outcome measures
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

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.

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Who is running the clinical trial?

AllerdermLead Sponsor
10 Previous Clinical Trials
767 Total Patients Enrolled
Curt Hamann, M.D.Study DirectorAllerderm (dba SmartPractice)

Media Library

Positive reactions, Concordance with reference allergen Clinical Trial Eligibility Overview. Trial Name: NCT04500834 — Phase 3
Atopic Dermatitis Research Study Groups: Positive reactions, Concordance with reference allergen
Atopic Dermatitis Clinical Trial 2023: Positive reactions, Concordance with reference allergen Highlights & Side Effects. Trial Name: NCT04500834 — Phase 3
Positive reactions, Concordance with reference allergen 2023 Treatment Timeline for Medical Study. Trial Name: NCT04500834 — Phase 3
~54 spots leftby Mar 2025
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