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:
2025-12-24 @ 5:50 PM
Ignite Modification Date:
2025-12-24 @ 5:50 PM
NCT ID:
NCT04537468
Eligibility Criteria:
Inclusion Criteria:
* Subject, male or female, aged 18 years or older at the time of consent.
* Female subjects of childbearing potential had a negative urine pregnancy test at the screening visit.
* Subjects had to be able and willing to provide written informed consent and comply with the requirements of the study protocol. Consent was obtained prior to any study-related procedures.
\*Special inclusion criteria for volunteers with atopic dermatitis or psoriasis:
* Patient had a history of atopic dermatitis or psoriasis.
* Patient with psoriasis had a Physician's Global Assessment (PGA) score of ≥2 at Day 0.
* Patients with atopic dermatitis had an Investigator's Global Assessment (IGA) score of ≥2 at Day 0.
Exclusion Criteria:
* Female subject was pregnant or breastfeeding.
* Subject was participating in a clinical trial with an experimental drug or device or had participated in a clinical trial with an experimental drug or device within the last 4 weeks of the collection day (Day 0).
* Subject was known to have hepatitis B or hepatitis C viral infection.
* Subject was known to have immune deficiency or was immunocompromised.
* Subject had used systemic medication, medical devices, UVB or PUVA therapy or natural health products to treat atopic dermatitis or psoriasis on the areas to be biopsied or tape stripped within 4 weeks of the collection day (Day 0).
* Subject had used oral, intravenous steroids, or immunosuppressive medication within 4 weeks of the collection day (Day 0). Subject had used intramuscular or intra-lesional or intra-articular steroids or immunosuppressive medication on the areas to be biopsied or tape stripped within 4 weeks of the collection day (Day 0).
* Subject had used a biologic within 12 weeks or 5 half-lives of the collection day (Day 0), whichever was longer.
* Subject had used topical medication, natural health products or medical devices to treat atopic dermatitis or psoriasis on the areas to be tape stripped or biopsied within 2 weeks of the collection day (Day 0).
\*Only for subjects who underwent skin biopsy:
* Subject had a known hypersensitivity/allergy to lidocaine.
* Subject had a history of hypertrophic scarring or keloid formation in scars or suture sites.
* Subject was taking anti-coagulant medication (e.g. heparin, low molecular weight \[LMW\]-heparin, warfarin, anti-platelets \[nonsteroidal anti-inflammatory drugs (NSAIDs) and low-dose aspirin (equal or lower than 81 mg) were not considered anti-platelets\]) or had a contraindication to skin biopsies.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04537468
Study Brief:
Protocol Section:
NCT04537468