An interventional study of Experimental stimulation with nickel discs in Allergic Contact Dermatitis Due to Nickel, sponsored by Herlev and Gentofte Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-11.
Sponsored by Herlev and Gentofte Hospital · Not applicable, Interventional, and Prevention
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:
52 studies on the registry are indexed under Dermatitis, Allergic Contact; 11 are open to participants now.
This study's enrollment of 30 is below the median of 45 across 41 interventional studies indexed under Dermatitis, Allergic Contact.
Browse Dermatitis, Allergic Contact studies →Herlev and Gentofte Hospital is the lead sponsor of 75 studies on the registry; 25 are open to participants now.
Counted across the registry records on this site, refreshed daily.
For patients with nickel allergy:
Inclusion Criteria:
Exclusion Criteria:
For Healthy volunteers:
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Experimental stimulation with nickel discs
Other: Experimental stimulation with nickel discs
Experimental stimulation with nickel discs
Other: Experimental stimulation with nickel discs
All participants will be exposed to 8 metal discs, 3 cm in diameter, 4 on each arm, placed on the volar side of the forearms (figure 1). Three of the metallic discs consists of \>99 wt.% nickel one consist of \>99wt.% Aluminium.The latter is used as a negative control. The discs will be applied under occlusion and with initial pressure and friction. One metallic disc with nickel, and one with aluminium, will be randomized for the earlobes on the patients with nickel allergy
Clinical evaluation of development of dermatitis after stimulation over time
Development of dermatitis after stimulation with nickel discs as a change from baseline skin assessment. The criteria developed by the International Contact Dermatitis Research Group (ICDRG), later modified by Hindsén and Bruze will be used for assessment
Time frame: 24 hours and 78 hours post stimulation with nickel discs
Change of baseline blood flow over time after stimulation
measure blood flow with laser doppler technique as a surrogate for inflammation on skin following stimulation with nickel discs over time
Time frame: 24 hours and 78 hours post stimulation with nickel discs
Nickel skin penetration at different time points after stimulation
by using the tape stripping technique we will measure the deposition of nickel and the penetration of nickel in the stratum corneum following stimulation
Time frame: Immediate deposition and penetration, 24 hours and 78 hours post stimulation of nickel discs
Plan to share: Undecided
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Dermatitis, Allergic Contact →
Herlev and Gentofte Hospital