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 @ 3:47 AM
Ignite Modification Date:
2025-12-25 @ 3:47 AM
NCT ID:
NCT07297602
Eligibility Criteria:
Inclusion Criteria:
* AD patients ≥ 12 years in whom systemic therapy is indicated.
* Patients who don't use other systemic therapy for AD in the last 2 months (or naïve who didn't use any systemic therapy before).
* Safe contraception during the study.
Exclusion Criteria:
* Pregnant or lactating women, as well as women of childbearing potential not using an effective method of contraception.
* Age \<12 years.
* Other concomitant AD systemic treatments such as cyclosporins and biologics.
* Previous systemic treatment of AD in the last 2 months.
* Patients receiving inducers or inhibitors of cytochromes CYP3A4 and CYP1A.
* Other systemic diseases other than COPD, especially hepatic impairment.
* Hypersensitivity to the active substance of roflumilast or to any of its excipients.
* The use of contraception with gestodene and ethinylestradiol.
* Unreliable patients.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT07297602
Study Brief:
Protocol Section:
NCT07297602