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

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bausch Health Americas, Inc.; Valeant Pharmaceuticals International, Inc.
• Collaborator: Dow Pharmaceutical Sciences

Criteria

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