Clinical Evaluation of Metal Panel Allergens: Safety and Efficacy Study

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-507972-35-00

Enrollment

105

Registered

2024-01-19

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic contact dermatitis Eczema

Brief summary

Concordance (agreement) between the hydrogel (investigational allergen) and petrolatum (reference allergen) patch testing methods using Cohen’s kappa calculation and by positive and negative percent agreement.

Detailed description

Measures of allergen safety and performance of device constituent.

Interventions

DRUGNickel(II)-sulfat

DRUG6*H2O 5%

DRUGTestsalbe

DRUGCopper Allergen (copper sulfate pentahydrate 2%)

DRUGTin Allergen (stannous chloride 1%)

DRUGManganese Allergen (manganese chloride tetrahydrate 2%)

DRUGMetal Panel Allergens

DRUGAmmonium Allergen (ammonium titanium oxide oxalate 21%)

DRUGZinc Allergen (zinc chloride 1%)

DRUGGold Allergen (gold sodium thiosulfate (GST) 2.0%)

DRUGSodium Allergen (sodium tetrachloropalladate 3%)

DRUGKobaltchlorid 1%

DRUGVanadium Allergen (vanadium oxide sulfate 1.3%)

DRUGKaliumdichromat 0

DRUG5%

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Concordance (agreement) between the hydrogel (investigational allergen) and petrolatum (reference allergen) patch testing methods using Cohen’s kappa calculation and by positive and negative percent agreement.	—

Secondary

Measure	Time frame
Measures of allergen safety and performance of device constituent.	—

Countries

Germany, Italy, Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026