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 @ 7:38 PM
Ignite Modification Date:
2025-12-24 @ 7:38 PM
NCT ID:
NCT02850003
Eligibility Criteria:
Key Inclusion Criteria:
* Male or female between the ages of 9 and \<17 (16 years 11 months)
* Written and verbal informed consent must be obtained. Subjects less than age of consent must sign an assent for the study and a parent or legal guardian must sign the informed consent.
* Subject must have a score of 3 (moderate) or 4 (severe) on the Evaluator's Global Severity assessment.
* Subject with facial acne inflammatory lesion count no less than 20 but no more than 40.
* Subject with facial acne non-inflammatory lesion count no less than 20 but no more than 100.
Key Exclusion Criteria:
* Use of an investigational drug or device within 30 days of enrollment, previous participation in a research study with IDP-120 Gel, or participation in a research study concurrent with this study.
* Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobate, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gram-negative folliculitis.
* Any underlying disease or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion counts inconclusive.
* Subjects with a facial beard or mustache that could interfere with the study assessments
* Subjects with more than 2 facial nodules.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
9 Years
Maximum Age:
17 Years
Study:
NCT02850003
Study Brief:
Protocol Section:
NCT02850003