Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 12:27 AM
NCT ID:
NCT05498467
Eligibility Criteria:
Inclusion Criteria:
* Aged at least eighteen years old.
* Able to provide written informed consent.
* Have a medical diagnosis of nickel allergy with at least a +2 reaction on the
* ICDRG scoring system when challenged with nickel.
* Fitzpatrick skin type 1-4.
* Able to speak and understand Danish.
Exclusion Criteria:
* Received any topical immunomodulating or immunosuppresive treatment on the lower back two weeks prior, or applied crème/lotion on the lower back 24 hours prior to day 0.
* Received systemic immunomodulating or immunosuppressive treatment four weeks prior to day 0.
* Any skin lesions at the area of interest such as nevi, scar tissue or pigment changes.
* Dermatitis and/or infection.
* Recent (3 months or less) administration of a live virus vaccine.
* Women of childbearing potential who are not taking adequate contraception or who are pregnant, plan to become pregnant during the study duration or lactating.
* Taking part in any other intervention study.
* Has any other condition which would, in the Investigator's opinion, deem the patient unsuitable for participation in the study (e.g. condition requiring long term or frequent oral steroid use).
* Presence of any condition or use of any medication which precludes the use of the study drug.
* Allergy to any of the ingredients in the drug.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05498467
Study Brief:
Protocol Section:
NCT05498467