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 @ 9:26 PM
Ignite Modification Date:
2025-12-24 @ 9:26 PM
NCT ID:
NCT02369432
Eligibility Criteria:
Inclusion Criteria:
* Healthy volunteers:
* Volunteers over 18
* Male volunteers under 65 or women of childbearing age (with a negative pregnancy test obtained at least 3 weeks before inclusion)
* Caucasian volunteers
* Volunteers having never shown any type of skin lesions regardless of its origin especially any allergic skin reactions.
* Volunteers having signed a free and informed consent form
* Volunteers affiliated to a social security system
* Patients:
* Patients over 18
* Male patients under 65 or women of childbearing age (with a negative pregnancy test obtained at least 3 weeks before inclusion)
* Caucasian patients
* Acute phase of atopic dermatitis with a SCORAD between 15 and 40
* Patients suffering from atopic dermatitis skin lesions ≥ 1.5 cm² on the inside of the forearm
* Patients having been treated by class II dermocorticoids with a two-week wash-out prior to inclusion
* Patients having signed a free and informed consent form
* Patients affiliated to a social security system
Exclusion Criteria:
* Participants under 18
* Pregnant or Breastfeeding women
* Post-menopausal women
* Patients having skin lesions adjacent to the selected area
* Patients with complications of atopic dermatitis
* SCORAD \<15 or \>40
* Patients being treated with a topical or a systemic treatment influencing the skin penetration of the microparticles
* Patients allergics to any component of the formulation
* Patients using cosmetic products on their forearms
* Patients planning to expose themselves to the sun
* Patients with a known immune deficiency
* Patients allergic to any product or device used before, during or after the skin biopsy
* Patients suffering from known wound healing disorders
* Patients with known inherited ou acquired hemostasis disorders
* Patients unable to follow the protocol requirements
* Patients currently involved in another clinical trial (or whose participation has ended less than 2 weeks before inclusion)
* Patients who are not affiliated to a social security system
* Patients in an exclusion period following participation in another clinical trial
* Incapacitated adults
* Participants placed under tutorship or curatorship
* Participants under judicial protection
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02369432
Study Brief:
Protocol Section:
NCT02369432