The Immunological Profile of Nickel Dermatitis
1 other identifier
interventional
26
1 country
1
Brief Summary
A dose-response study on the immune phenotype of allergic nickel dermatitis on a previously exposed skin area.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2020
CompletedFirst Posted
Study publicly available on registry
June 18, 2020
CompletedStudy Start
First participant enrolled
March 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2022
CompletedJanuary 4, 2023
April 1, 2022
1.3 years
June 16, 2020
January 3, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
mRNA Nanostring screening
Screening of 600 immune-related genes
1 month
Secondary Outcomes (1)
Protein verification
2 month
Other Outcomes (1)
Allergic response
1 day
Study Arms (2)
Nickel allergic individuals
EXPERIMENTALNickel 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 COMPARATORNickel sulfate hexahydrate in petrolatum. Exposed in a patch test dose-range with a max concentration of 5% nickel sulfate hexahydrate
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- Participation in another scientific experiment within the last 4 weeks. risks,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Allergy Research Center
Hellerup, Danmark, 2900, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jeanne D Johansen, Proff.
National Allergy Research Center, Denmark
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2020
First Posted
June 18, 2020
Study Start
March 1, 2021
Primary Completion
June 1, 2022
Study Completion
June 1, 2022
Last Updated
January 4, 2023
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share