Clinical Study to Test the Efficacy and Safety of ACYC to Treat Moderate to Severe Acne

A Phase 3, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, 2-Arm, Parallel Group Comparison Study Comparing the Efficacy and Safety of ACYC and ACYC Vehicle Gel in the Treatment of Acne Vulgaris

The primary objective of this study is to compare the efficacy and safety and tolerability of ACYC Gel and vehicle in the treatment of subjects with Acne Vulgaris.

The primary objective of this study is to compare the efficacy and safety and tolerability of ACYC Gel and vehicle in the treatment of subjects with Acne Vulgaris

Key Inclusion Criteria:

• Male or female between the ages of 12 and 40 (inclusive)
• Written and verbal informed consent must be obtained.
• Subjects less than 18 years of age must sign an assent for the study and a parent or a legal guardian must sign the informed consent
• Subject must have moderate to severe acne at the baseline visit
• Women of childbearing potential must be willing to practice effective contraception for the duration of the study

Key Exclusion Criteria:

• Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study
• Dermatological conditions on the face that could interfere with clinical evaluations