Allergic Contact Dermatitis Due to NickelNCT03309215
Short Repeated Nickel Exposures
A study testing Experimental stimulation with nickel discs in people with Allergic Contact Dermatitis Due to Nickel, run by Herlev and Gentofte Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Contact Dermatitis Due to Nickel
- What is being tested?
- Experimental stimulation with nickel discs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 16 Sep 2017to 10 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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
Show all 19Show fewer
- 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:
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read more
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.
- Being tested
- Experimental stimulation with nickel discs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental stimulation with nickel discsOther
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
| Study group | Role | What they receive |
|---|---|---|
| Patients with nickel allergy | Experimental | Experimental stimulation with nickel discs Receives: Other: Experimental stimulation with nickel discs |
| Persons without nickel allergy | Experimental | Experimental stimulation with nickel discs Receives: Other: Experimental stimulation with nickel discs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Immediate deposition and penetration, 24 hours and 78 hours post stimulation of nickel discs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2017
- Study start16 Sep 2017
- Primary completion10 Dec 2017
- Study completion10 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Allergic Contact Dermatitis Due to NickelStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev and Gentofte Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Principal investigator, Malin Glindvad Ahlström, Herlev and Gentofte Hospital
- Investigators
- Malin G Ahlström, MD, Principal investigator, National Allergy Research Centre, Department of Allergy and Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03309215
- Sponsor's protocol ID
- H-16050296
- Other IDs
- HGH-2017-027
- Status last verified
- Feb 2020
- First submitted
- 4 Oct 2017
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 26086991Hostynek 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.
PubMed 11802472Emilson 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.
PubMed 8105620Fullerton 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.
PubMed 3207621
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical Implication of Short Repeated Nickel Exposures
- ClinicalTrials.gov ID
- NCT03309215
- Acronym / sponsor ID
- H-16050296
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Herlev and Gentofte HospitalUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- 16 Sep 2017 (actual)
- Primary completion
- 10 Dec 2017 (actual)
- Study completion
- 10 Dec 2017 (actual)
- First posted
- 13 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with nickel allergy | Experimental | Other: Experimental stimulation with nickel discsExperimental stimulation with nickel discs |
| Persons without nickel allergy | Experimental | Other: Experimental stimulation with nickel discsExperimental stimulation with nickel discs |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
- 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.
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental stimulation with nickel discsAll 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 | Other | Patients with nickel allergy, Persons without nickel allergy |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Results publication: PubMed 26086991Erfani 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 publication: PubMed 11802472Hostynek 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 publication: PubMed 8105620Emilson 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 publication: PubMed 3207621Fullerton 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.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Allergic Contact Dermatitis Due to Nickel
Recruiting
Environmental Exposure to Heavy Metals, Nanoparticles, and Emergent Contaminants and Risk of Allergic Diseases
Allergic Contact Dermatitis, Metal Allergy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malin G Ahlström, MD principal investigator
National Allergy Research Centre, Department of Allergy and Dermatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental stimulation with nickel discs in people with Allergic Contact Dermatitis Due to Nickel, run by Herlev and Gentofte Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical evaluation of development of dermatitis after stimulation over time (time frame: 24 hours and 78 hours post stimulation with nickel discs). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03309215, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2020.