Nickel; EczemaNCT04438330
The Immunological Profile of Nickel Dermatitis
A study testing Nickel sulfate hexahydrate in people with Nickel; Eczema and Nickel Sensitivity, run by National Allergy Research Center, Denmark at 1 site in Denmark.
Trial summary
A dose-response study on the immune phenotype of allergic nickel dermatitis on a previously exposed skin area. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nickel; Eczema, Nickel Sensitivity, Allergy
- What is being tested?
- Nickel sulfate hexahydrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Mar 2021to 1 Jun 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be able to understand the written and oral participant information in Danish.
- Previously proven nick allergy by patch testing within the last 5 years, for the nickel allergic test participants.
Who cannot join
- Pregnancy and / or breastfeeding.
- Systemic immunomodulatory treatments within the last 14 days.
- Local treatments of selected skin areas, such as applying hormone cream within the last two weeks or applying cream / lotion within 24 hours up to sample collection.
- Allergy to local anesthesia.
- Exposed to solar or sunlight on the back within 21 days.
- History of inflammatory skin diseases, asthma, Diabetes Mellitus, hives or arthritis (exclusion criteria only for participation in the healthy control group).
- Participation in another scientific experiment within the last 4 weeks. risks,
Trial locations and contacts
1 site in 1 country.
About this study
A dose-response study on the immune phenotype of allergic nickel dermatitis on a previously exposed skin area.
Read the detailed description
Clinically controlled study comprising 15 people with known nickel allergy and 15 healthy persons as control group. At the Department of Allergy and Dermatology, Gentofte Hospital, test participants will be exposed to nickel sulfate in a patch test on their back, which will create an eczema reaction in people with nickel allergy and induce skin resident T-cells. The resident T-cells will enhance further exposure. The eczema is healed over 3-4 weeks, after which the same areas are again exposed to nickel sulfate at different concentrations in a patch test. Skin biopsies of the exposed areas are taken and the immune phenotype is analyzed trough Nanostring RNA technologies of around 600 immunerelated genes.
- Conditions
- Nickel; Eczema, Nickel Sensitivity, Allergy, Inflammatory Response
- Being tested
- Nickel sulfate hexahydrate
- Keywords
- Patch test, metal allergy
- Medical subject headings
- Eczema, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nickel sulfate hexahydrateOther
Patch test
| Study group | Role | What they receive |
|---|---|---|
| Nickel allergic individuals | Experimental | Nickel sulfate hexahydrate in petrolatum. Exposed in a patch test dose-range with a max concentration of 5% nickel sulfate hexahydrate Receives: Other: Nickel sulfate hexahydrate |
| non-nickel allergic individuals | Active comparator | Nickel sulfate hexahydrate in petrolatum. Exposed in a patch test dose-range with a max concentration of 5% nickel sulfate hexahydrate Receives: Other: Nickel sulfate hexahydrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
mRNA Nanostring screening
Screening of 600 immune-related genes
Measured: 1 month
Secondary outcomes (1)
Protein verification
verification of differentially regulated mRNA at a protein level.
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start1 Mar 2021
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nickel; EczemaStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Allergy Research Center, Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen
- Responsible party
- Sponsor
- Investigators
- Jeanne D Johansen, Proff., Study director, National Allergy Research Center, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04438330
- Sponsor's protocol ID
- H-19080328
- Status last verified
- Apr 2022
- First submitted
- 16 Jun 2020
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Immunological Profile of Nickel Dermatitis
- ClinicalTrials.gov ID
- NCT04438330
- Acronym / sponsor ID
- H-19080328
- Conditions
- Nickel; Eczema, Nickel Sensitivity, Allergy, Inflammatory Response
- Keywords
- Patch test, metal allergy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- National Allergy Research Center, DenmarkUniversity, hospital or other
- Collaborators
- University of Copenhagen
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 18 Jun 2020 (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.
A dose-response study on the immune phenotype of allergic nickel dermatitis on a previously exposed skin area.
Detailed description
Clinically controlled study comprising 15 people with known nickel allergy and 15 healthy persons as control group. At the Department of Allergy and Dermatology, Gentofte Hospital, test participants will be exposed to nickel sulfate in a patch test on their back, which will create an eczema reaction in people with nickel allergy and induce skin resident T-cells. The resident T-cells will enhance further exposure. The eczema is healed over 3-4 weeks, after which the same areas are again exposed to nickel sulfate at different concentrations in a patch test. Skin biopsies of the exposed areas are taken and the immune phenotype is analyzed trough Nanostring RNA technologies of around 600 immunerelated genes.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nickel allergic individuals | Experimental | Other: Nickel sulfate hexahydrateNickel sulfate hexahydrate in petrolatum. Exposed in a patch test dose-range with a max concentration of 5% nickel sulfate hexahydrate |
| non-nickel allergic individuals | Active comparator | Other: Nickel sulfate hexahydrateNickel sulfate hexahydrate in petrolatum. Exposed in a patch test dose-range with a max concentration of 5% nickel sulfate hexahydrate |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Must be able to understand the written and oral participant information in Danish.
- Previously proven nick allergy by patch testing within the last 5 years, for the nickel allergic test participants.
Key exclusion criteria (7 listed)
- Pregnancy and / or breastfeeding.
- Systemic immunomodulatory treatments within the last 14 days.
- Local treatments of selected skin areas, such as applying hormone cream within the last two weeks or applying cream / lotion within 24 hours up to sample collection.
- Allergy to local anesthesia.
- Exposed to solar or sunlight on the back within 21 days.
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 |
|---|---|---|
| Nickel sulfate hexahydratePatch test | Other | Nickel allergic individuals, non-nickel allergic individuals |
Primary outcome
mRNA Nanostring screening
Time frame: 1 month
Screening of 600 immune-related genes
1 secondary outcome
Protein verification
Time frame: 2 month
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 4 Jan 2023.
- Individual participant dataSharing planned: No
Related trials for Nickel; Eczema
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.
Jeanne D Johansen, Proff. study director
National Allergy Research Center, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nickel sulfate hexahydrate in people with Nickel; Eczema and Nickel Sensitivity, run by National Allergy Research Center, Denmark 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 2 inclusion and 7 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 4 Jan 2023. 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?
mRNA Nanostring screening (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jan 2023.