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Short Repeated Nickel Exposures

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ClinicalTrials.gov Identifier: NCT03309215
Recruitment Status : Completed
First Posted : October 13, 2017
Last Update Posted : February 1, 2018
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
Malin Glindvad Ahlström, Herlev and Gentofte Hospital

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Allergic Contact Dermatitis Due to Nickel Other: Experimental stimulation with nickel discs Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Evaluation of the Clinical Implication of Short Repeated Nickel Exposures
Actual Study Start Date : September 16, 2017
Actual Primary Completion Date : December 10, 2017
Actual Study Completion Date : December 10, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Nickel

Arm Intervention/treatment
Experimental: Patients with nickel allergy
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


Experimental: Persons without nickel allergy
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





Primary Outcome Measures :
  1. 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

  2. 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

  3. 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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03309215


Locations
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Denmark
Department of Allergy and Dermatology
Hellerup, Denmark, 2900
Sponsors and Collaborators
Herlev and Gentofte Hospital
Karolinska Institutet
Investigators
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Principal Investigator: Malin G Ahlström, MD National Allergy Research Centre, Department of Allergy and Dermatology

Additional Information:
Publications of Results:
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Responsible Party: Malin Glindvad Ahlström, MD, Ph.d.-student, Herlev and Gentofte Hospital
ClinicalTrials.gov Identifier: NCT03309215     History of Changes
Other Study ID Numbers: H-16050296
HGH-2017-027 ( Other Identifier: Data Protection Agency Region Hovedstaden )
First Posted: October 13, 2017    Key Record Dates
Last Update Posted: February 1, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dermatitis
Dermatitis, Contact
Dermatitis, Allergic Contact
Skin Diseases
Skin Diseases, Eczematous
Hypersensitivity, Delayed
Hypersensitivity
Immune System Diseases
Nickel
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs