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Short Repeated Nickel Exposures

Primary Purpose

Allergic Contact Dermatitis Due to Nickel

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Experimental stimulation with nickel discs

About this trial

This is an interventional prevention trial for Allergic Contact Dermatitis Due to Nickel

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Department of Allergy and Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Patients with nickel allergy

Persons without nickel allergy

Arm Description

Experimental stimulation with nickel discs

Outcomes

Primary Outcome Measures

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

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03309215

First Posted

October 4, 2017

Last Updated

February 10, 2020

Sponsor

Herlev and Gentofte Hospital

Collaborators

Karolinska Institutet

1. Study Identification

Unique Protocol Identification Number

NCT03309215

Brief Title

Short Repeated Nickel Exposures

Official Title

Evaluation of the Clinical Implication of Short Repeated Nickel Exposures

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

September 16, 2017 (Actual)

Primary Completion Date

December 10, 2017 (Actual)

Study Completion Date

December 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Herlev and Gentofte Hospital

Collaborators

Karolinska Institutet

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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: 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergic Contact Dermatitis Due to Nickel

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Patients with nickel allergy

Arm Type

Experimental

Arm Description

Experimental stimulation with nickel discs

Arm Title

Persons without nickel allergy

Arm Type

Experimental

Arm Description

Experimental stimulation with nickel discs

Intervention Type

Other

Intervention Name(s)

Experimental stimulation with nickel discs

Intervention Description

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 Measure Information:

Title

Clinical evaluation of development of dermatitis after stimulation over time

Description

Time Frame

24 hours and 78 hours post stimulation with nickel discs

Title

Change of baseline blood flow over time after stimulation

Description

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

Title

Nickel skin penetration at different time points after stimulation

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Malin G Ahlström, MD

Organizational Affiliation

National Allergy Research Centre, Department of Allergy and Dermatology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Allergy and Dermatology

City

Hellerup

ZIP/Postal Code

2900

Country

Denmark

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

26086991

Citation

Erfani B, Liden C, Midander K. Short and frequent skin contact with nickel. Contact Dermatitis. 2015 Oct;73(4):222-30. doi: 10.1111/cod.12426. Epub 2015 Jun 18.

Results Reference

result

PubMed Identifier

11802472

Citation

Hostynek JJ, Dreher F, Nakada T, Schwindt D, Anigbogu A, Maibach HI. Human stratum corneum adsorption of nickel salts. Investigation of depth profiles by tape stripping in vivo. Acta Derm Venereol Suppl (Stockh). 2001;(212):11-8. doi: 10.1080/000155501753279587.

Results Reference

result

PubMed Identifier

8105620

Citation

Emilson A, Lindberg M, Forslind B. The temperature effect on in vitro penetration of sodium lauryl sulfate and nickel chloride through human skin. Acta Derm Venereol. 1993 Jun;73(3):203-7. doi: 10.2340/0001555573203207.

Results Reference

result

PubMed Identifier

3207621

Citation

Fullerton A, Hoelgaard A. Binding of nickel to human epidermis in vitro. Br J Dermatol. 1988 Nov;119(5):675-82. doi: 10.1111/j.1365-2133.1988.tb03482.x.

Results Reference

result

Links:

URL

https://www.ncbi.nlm.nih.gov/pubmed/3207621

Description

Related Info

URL

https://www.ncbi.nlm.nih.gov/pubmed/?term=The+temperature+effect+on+in+vitro+penetration+of+sodium+lauryl+sulfate+and+nickel+chloride+through+human+skin.+Acta+Derm+Venereol.

Description

Related Info

URL

https://www.ncbi.nlm.nih.gov/pubmed/?term=Short+and+frequent+skin+contact+with+nickel

Description

Related Info

URL

https://www.ncbi.nlm.nih.gov/pubmed/?term=Human+stratum+corneum+adsorption+of+nickel+salts.+Investigation+of+depth+profiles+by+tape+stripping+in+vivo.

Description

Related Info

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Short Repeated Nickel Exposures

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