Completed

NCT Number: NCT03309215

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Allergic Contact Dermatitis Due to Nickel

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Allergy and Dermatology

Hellerup, 2900, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

For patients with nickel allergy:

Inclusion criteria

Positive patch test to nickel sulphate 5% pet. according to European society of contact dermatitis(ESCD) guidelines within the last 5 years at the Department of Dermatology and Allergy, Gentofte Hospital.
Age 18-75 years.

Exclusion criteria

Active eczema in test areas
Generalized eczema
Scar tissue in test areas.
Pregnancy or breast feeding
Treatment with topical corticosteroids or other immune-suppressants on/near test areas within four weeks prior to study start
Systemic immunomodulatory* treatment within 4 weeks prior to study start
UV exposure of test areas within three weeks prior to study start
Participation in other clinical studies within four weeks prior to study start
Unable to cooperate or communicate with the investigators *Systemic immunomodulatory treatment is drugs taken orally or by injection that modify the response of the immune system by increasing (immunostimulators) or decreasing (immunosuppressives) the production of serum antibodies

For Healthy volunteers:

Inclusion criteria

Negative patch test result to nickel sulphate 5% pet. according to ESCD guidelines (48) at the Department of Dermatology and Allergy, Gentofte Hospital
Age 18-75 years.

Exclusion criteria

History of contact allergy
Generalized eczema
Scar tissue in test areas.
Pregnancy or breast feeding
Treatment with topical corticosteroids or other immune-suppressants on/near test areas within four weeks prior to study start
Systemic immunomodulatory treatment within four weeks prior to study start
UV exposure of test areas within three weeks prior to study start
Participation in other clinical studies within four weeks prior to study start
Unable to cooperate or communicate with the investigators

Treatment and study plan

Experimental stimulation with nickel discs

Other

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

Primary outcomes

Clinical evaluation of development of dermatitis after stimulation over time

Time frame: 24 hours and 78 hours post stimulation with nickel discs

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
Change of baseline blood flow over time after stimulation

Time frame: 24 hours and 78 hours post stimulation with nickel discs

measure blood flow with laser doppler technique as a surrogate for inflammation on skin following stimulation with nickel discs over time
Nickel skin penetration at different time points after stimulation

Time frame: Immediate deposition and penetration, 24 hours and 78 hours post stimulation of nickel discs

by using the tape stripping technique we will measure the deposition of nickel and the penetration of nickel in the stratum corneum following stimulation

Sponsors and collaborators

Lead sponsor

Herlev and Gentofte Hospital

Other

Collaborators

Karolinska Institutet

Registry information

Official study title

Evaluation of the Clinical Implication of Short Repeated Nickel Exposures

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2017
First posted: Oct 13, 2017
Registry last updated: Feb 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.