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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.

Tracking Information
First Submitted Date  ICMJE September 27, 2012
First Posted Date  ICMJE October 4, 2012
Results First Submitted Date  ICMJE January 15, 2015
Results First Posted Date  ICMJE January 10, 2017
Last Update Posted Date June 4, 2018
Study Start Date  ICMJE October 2012
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 11, 2016)
  • Absolute Change in Inflammatory Lesion Count [ Time Frame: Baseline and 12 Weeks ]
  • Absolute Change in Non-inflammatory Lesion Count [ Time Frame: Baseline and 12 Weeks ]
  • Percent of Subjects Who Have a Least a 2 Grade Reduction [ Time Frame: 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 2, 2012)
  • Absolute Change in Inflammatory Lesion Count [ Time Frame: Baseline and 12 Weeks ]
  • Absolute Change in Non-inflammatory Lesion Count [ Time Frame: Baseline and 12 Weeks ]
  • Proportion of subjects who have a least a 2 grade reduction [ Time Frame: Baseline and 12 Weeks ]
Change History Complete list of historical versions of study NCT01701024 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: October 2, 2012)
  • Percent change in inflammatory lesion count [ Time Frame: Baseline and 12 Weeks ]
  • Percent change in non-inflammatory lesion count [ Time Frame: Baseline and 12 Weeks ]
  • Proportion of subjects who have a least a 2 grade reduction in the Evaluator's Global Severity Score and were clear or almost clear [ Time Frame: Baseline and 12 Weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Study to Test the Efficacy and Safety of ACYC to Treat Moderate to Severe Acne
Official Title  ICMJE 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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acne
Intervention  ICMJE
  • Drug: ACYC
    ACYC active, topically applied to the face for 12 weeks
  • Drug: ACYC vehicle
    ACYC vehicle (placebo), topically applied to the face for 12 weeks
Study Arms  ICMJE
  • Active Comparator: ACYC
    ACYC active, topically applied to the face for 12 weeks
    Intervention: Drug: ACYC
  • Placebo Comparator: ACYC vehicle
    ACYC vehicle (placebo), topically applied to the face for 12 weeks
    Intervention: Drug: ACYC vehicle
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 11, 2016)
498
Original Estimated Enrollment  ICMJE
 (submitted: October 2, 2012)
500
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 40 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01701024
Other Study ID Numbers  ICMJE V01-ACYC-301
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Bausch Health Americas, Inc.
Study Sponsor  ICMJE Bausch Health Americas, Inc.
Collaborators  ICMJE Dow Pharmaceutical Sciences
Investigators  ICMJE
Study Director: Nilima Justice, M.D. Medical Monitor, Valeant Pharmaceuticals
PRS Account Bausch Health Americas, Inc.
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP