Allergic Contact Dermatitis Due to Nickel Clinical Trial
Official title:
Evaluation of the Clinical Implication of Short Repeated Nickel Exposures
The former Nickel Directive was introduced in EU in 1994 limiting the release of nickel from
items intended for prolonged contact with skin. The nickel regulation entered into full force
in 2001 and became a part of REACH (the EU chemicals regulation) in 2009. Since then the
prevalence of nickel allergy has declined in some countries, but not in others, following the
implementation. Young individuals still become allergic to nickel (2, 3) and a high
prevalence of nickel allergy, exceeding 10%, is seen among young women (below 30 years) in
the general population.
The EU nickel regulation has been changing over time. The present limits of nickel release
for metallic items intended for direct and prolonged contact with the skin is <0.5
μg/cm2/week and <0.2 μg/cm2/week for any post assemblies inserted into pierced holes. In
2014, EU defined prolonged contact with the skin as: at least 30 minutes on one or more
occasions within two weeks for items with continuous skin contact, or to at least 10 minutes
on three or more occasions within two weeks (7).
The overall objective is to evaluate how well the EU nickel regulation protects individuals
against developing nickel dermatitis. More specifically we will:
1. Study the penetration of nickel in normal and irritated skin after short repeated skin
exposure under controlled temperature in nickel sensitized patients and in healthy
controls
2. Reveal the potential of short repeated nickel skin exposure on normal and irritated skin
to elicit dermatitis, during controlled climate factors in nickel sensitized patients
and controls using the time restrictions of the definition of prolonged skin contact in
the nickel regulation.
n/a