Absorption and Systematic Pharmacokinetics of Topically Applied IDP-120 Gel

A Phase 1b Open-Label Study Evaluating the Absorption and Systematic Pharmacokinetics of Topically Applied IDP-120 Gel in Subjects With Acne Vulgaris Under Maximal Use Conditions

Study designed to assess the safety and plasma PK of tretinoin and its metabolites from topically applied IDP-120 gel.

An Open-label study designed to assess the safety and plasma PK of tretinoin and its metabolites from topically applied IDP-120 gel.

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.