Absorption and Systematic Pharmacokinetics of Topically Applied IDP-120 Gel
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Evaluators Global Severity Score At Day 15 [ Time Frame: 15 Days ]
Acne severity will be determined by the investigator/evaluator based on the global assessment of the inflammatory and non-inflammatory lesions of facial acne. Evaluations will be graded on a static scale ranging from 0 (clear) to 4 (severe).
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Ages Eligible for Study:
9 Years to 17 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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