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 @ 5:08 AM
Ignite Modification Date:
2025-12-25 @ 5:08 AM
NCT ID:
NCT04371627
Eligibility Criteria:
Inclusion Criteria:
* Male or female ≥ 4 years of age
* Prior participation in a Viaskin® Peanut REALISE or PEOPLE clinical study for peanut-allergic patients
Exclusion Criteria:
* Pregnancy or lactation or planning a pregnancy.
* Generalized dermatologic disease (for example, active atopic dermatitis, uncontrolled generalized active eczema, ichthyosis vulgaris) extending widely on the skin and especially on the back with no intact zones to apply the Viaskin® patches.
* Patients who developed hypersensitivity to excipients of the Viaskin® patches.
* Received or planning to receive anti-tumor necrosis factor drugs or anti-IgE drugs (such as omalizumab) or any biologic immunomodulatory therapy.
* Receiving or planning to receive any other type of immunotherapy to any food (for example, EPIT, OIT, or SLIT or specific oral tolerance induction) or any aeroallergen or venom immunotherapy during their participation in the study.
* Use of cyclosporine or other immunosuppressive agents within 3 months before entering the study. Topical calcineurin inhibitors are permitted.
* A history of important non-compliance during the REALISE or PEOPLE studies. Important non-compliance includes patients not applying the patches for 60 or more days in total and/or for 30 or more consecutive days during the REALISE or PEOPLE studies.
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
12 Years
Study:
NCT04371627
Study Brief:
Protocol Section:
NCT04371627