Absorption and Systematic Pharmacokinetics of Topically Applied IDP-120 Gel

• Status: Completed
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bausch Health Americas, Inc.; Valeant Pharmaceuticals International, Inc.

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.