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Clinical Evaluation of Metal Panel Allergens: Mercury, Aluminum and Palladium Dose Response Study

NCT02028208 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2020-08-24

Study results available
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Summary

The purpose of this study is to evaluate the diagnostic performance and safety of ascending doses of mercury, aluminum and palladium metal allergens proposed for inclusion in a metal allergen panel. Optimal dose will be selected based on the lowest dose of each allergen eliciting a positive response in 70-90% of subjects tested.

Conditions

  • Contact Dermatitis

Interventions

DIAGNOSTIC_TEST

Ammoniated mercury

Metal allergen panel containing ascending doses of ammoniated mercury and a negative control.

DIAGNOSTIC_TEST

Aluminum chloride and aluminum lactate

Metal allergen panel containing ascending doses of alumium chloride, aluminum lactate and a negative control.

DIAGNOSTIC_TEST

Sodium tetrachloropalladate

Metal allergen panel containing ascending doses of sodium tetrachloropalladate and a negative control.

Sponsors & Collaborators

  • Allerderm

    lead INDUSTRY

Principal Investigators

  • Marlene Isaksson, MD · Skane University Hospital Malmo

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-04
Primary Completion
2016-05-24
Completion
2016-05-24

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02028208 on ClinicalTrials.gov