NCT02028208

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Allerderm · Industry
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a single-center, double-blind, randomized study to compare the diagnostic performance (primary) and safety (secondary) of ascending doses of mercury, aluminum and palladium in 20 adult subjects who have a clinical history of contact dermatitis and have had a past positive patch test to one of the allergens on this study. Investigators and subjects will be blinded to the exact location of each dose within the allergen panel but will not be blinded to the allergen being tested, nor the range of allergen doses within each panel.

Conditions

• Contact Dermatitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2013-11-04
• Primary completion: 2016-05-24
• Completion: 2016-05-24
• First posted: 2014-01-07
• Last updated: 2020-08-24
• Results posted: 2020-08-24

Locations

1 site across 1 country: Sweden