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

• ClinicalTrials.gov Identifier: NCT01701024
• Recruitment Status: Completed
• First Posted: October 4, 2012
• Results First Posted: January 10, 2017
• Last Update Posted: June 4, 2018
• Sponsor: Bausch Health Americas, Inc.
• Collaborator: Dow Pharmaceutical Sciences
• Information provided by (Responsible Party): Bausch Health Americas, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Acne	Drug: ACYC; Drug: ACYC vehicle	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 498 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: October 2012
• Actual Primary Completion Date: May 2013
• Actual Study Completion Date: July 2013

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: ACYC; ACYC active, topically applied to the face for 12 weeks	Drug: ACYC; ACYC active, topically applied to the face for 12 weeks
Placebo Comparator: ACYC vehicle; ACYC vehicle (placebo), topically applied to the face for 12 weeks	Drug: ACYC vehicle; ACYC vehicle (placebo), topically applied to the face for 12 weeks

Outcome Measures

Primary Outcome Measures :

1. Absolute Change in Inflammatory Lesion Count [ Time Frame: Baseline and 12 Weeks ]
2. Absolute Change in Non-inflammatory Lesion Count [ Time Frame: Baseline and 12 Weeks ]
3. Percent of Subjects Who Have a Least a 2 Grade Reduction [ Time Frame: Baseline and 12 Weeks ]
4. Percent of Subjects With Two Grade Reduction From Baseline and Achieving Clear or Almost Clear [ Time Frame: Baseline and 12 Weeks ]

Eligibility Criteria

• Ages Eligible for Study: 12 Years to 40 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

  Hide Study Locations

Locations

United States, Alabama

Mobile, Alabama, United States, 36608

United States, California

Los Angeles, California, United States, 90045

San Diego, California, United States, 92123

United States, Connecticut

New Haven, Connecticut, United States, 06511

United States, Florida

Aventura, Florida, United States, 33180

United States, Illinois

Naperville, Illinois, United States, 60563

United States, Indiana

Evansville, Indiana, United States, 47714

South Bend, Indiana, United States, 46617

United States, Kentucky

Louisville, Kentucky, United States, 40202

United States, Michigan

Clinton Township, Michigan, United States, 48038

United States, Minnesota

Fridley, Minnesota, United States, 55432

United States, Nebraska

Omaha, Nebraska, United States, 68144

United States, New Mexico

Albuquerque, New Mexico, United States, 87106

United States, New York

Rochester, New York, United States, 14623

United States, North Carolina

Raleigh, North Carolina, United States, 27612

United States, Oregon

Portland, Oregon, United States, 97210

United States, Tennessee

Goodlettsville, Tennessee, United States, 37072

United States, Texas

Austin, Texas, United States, 78759

College Station, Texas, United States, 77845

Houston, Texas, United States, 77056

San Antonio, Texas, United States, 78250

United States, Utah

Salt Lake City, Utah, United States, 84117

United States, Virginia

Lynchburg, Virginia, United States, 24501

Norfolk, Virginia, United States, 23507

Sponsors and Collaborators

Bausch Health Americas, Inc.

Dow Pharmaceutical Sciences

Investigators

• Study Director: Nilima Justice, M.D.; Medical Monitor, Valeant Pharmaceuticals

More Information

• Responsible Party: Bausch Health Americas, Inc.
• ClinicalTrials.gov Identifier: NCT01701024 History of Changes
• Other Study ID Numbers: V01-ACYC-301
• First Posted: October 4, 2012
• Results First Posted: January 10, 2017
• Last Update Posted: June 4, 2018
• Last Verified: May 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

Keywords provided by Bausch Health Americas, Inc.:

Acne

Additional relevant MeSH terms:

Acne Vulgaris; Acneiform Eruptions; Skin Diseases; Sebaceous Gland Diseases