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

Phase 3

Completed

• Conditions: Acne
• Interventions: Drug: ACYC; Drug: ACYC vehicle

• Registration Number: NCT01701024
• Lead Sponsor: Bausch Health Americas, Inc.

Brief 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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2012-09-27
• Study Start: 2012-10
• Study First Submitted QC: 2012-10-02
• Study First Posted: 2012-10-04
• Primary Completion: 2013-05
• Study Completion: 2013-07
• Results First Submitted: 2015-01-15
• Results First Submitted QC: 2016-11-11
• Results First Posted: 2017-01-10
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-02
• Last Update Posted: 2018-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 498

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACYC	ACYC	ACYC active, topically applied to the face for 12 weeks
ACYC vehicle	ACYC vehicle	ACYC vehicle (placebo), topically applied to the face for 12 weeks

Primary Outcome Measures

Name	Time	Method
Absolute Change in Inflammatory Lesion Count	Baseline and 12 Weeks
Absolute Change in Non-inflammatory Lesion Count	Baseline and 12 Weeks
Percent of Subjects With Two Grade Reduction From Baseline and Achieving Clear or Almost Clear	Baseline and 12 Weeks
Percent of Subjects Who Have a Least a 2 Grade Reduction	Baseline and 12 Weeks