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

May 2, 2018 updated by: Bausch Health Americas, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

498

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
    • California
      • Los Angeles, California, United States, 90045
      • San Diego, California, United States, 92123
    • Connecticut
      • New Haven, Connecticut, United States, 06511
    • Florida
      • Aventura, Florida, United States, 33180
    • Illinois
      • Naperville, Illinois, United States, 60563
    • Indiana
      • Evansville, Indiana, United States, 47714
      • South Bend, Indiana, United States, 46617
    • Kentucky
      • Louisville, Kentucky, United States, 40202
    • Michigan
      • Clinton Township, Michigan, United States, 48038
    • Minnesota
      • Fridley, Minnesota, United States, 55432
    • Nebraska
      • Omaha, Nebraska, United States, 68144
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
    • New York
      • Rochester, New York, United States, 14623
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
    • Oregon
      • Portland, Oregon, United States, 97210
    • Tennessee
      • Goodlettsville, Tennessee, United States, 37072
    • Texas
      • Austin, Texas, United States, 78759
      • College Station, Texas, United States, 77845
      • Houston, Texas, United States, 77056
      • San Antonio, Texas, United States, 78250
    • Utah
      • Salt Lake City, Utah, United States, 84117
    • Virginia
      • Lynchburg, Virginia, United States, 24501
      • Norfolk, Virginia, United States, 23507

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 40 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch Health Americas, Inc.

Collaborators

Dow Pharmaceutical Sciences

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (ACTUAL)

May 1, 2013

Study Completion (ACTUAL)

July 1, 2013

Study Registration Dates

First Submitted

September 27, 2012

First Submitted That Met QC Criteria

October 2, 2012

First Posted (ESTIMATE)

October 4, 2012

Study Record Updates

Last Update Posted (ACTUAL)

June 4, 2018

Last Update Submitted That Met QC Criteria

May 2, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V01-ACYC-301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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