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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Collaborator:
Dow Pharmaceutical Sciences
Information provided by (Responsible Party):
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.

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

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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne

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




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 ]


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01701024


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

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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    Key Record Dates
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:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases