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 @ 2:35 PM
Ignite Modification Date:
2025-12-24 @ 2:35 PM
NCT ID:
NCT04594759
Eligibility Criteria:
Inclusion Criteria:
* All patients 12 years and older with the diagnosis of moderate acne vulgaris
Exclusion Criteria:
* Patients who are at baseline on long-term tetracycline antibiotics, long-term trimethoprim-sulfamethoxazole, or on spironolactone for any reason
* Patients who have taken isotretinoin in the past 6 months
* Patients with hypersensitivity to isotretinoin or to any of its components
* Females who are pregnant, likely to become pregnant, or will be breast-feeding during the study period
* Patients with a history of major depression, mania, or psychosis with an active episode during the past year including current psychotic symptoms and/or current suicidal ideation
* Adult patients with cognitive impairment
* Patients with baseline kidney or liver disease
* Patients with baseline hypertriglyceridemia
* Patients with history of or current pseudotumor cerebri
* Patients with any clinically significant unstable medical condition which could pose a risk to the safety of the patient
* Inability or unwillingness of subject or legal guardian/representative to give informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT04594759
Study Brief:
Protocol Section:
NCT04594759