We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01701024
First Posted: October 4, 2012
Last Update Posted: January 10, 2017
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.
Collaborator:
Dow Pharmaceutical Sciences
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.
  Purpose
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 Intervention Phase
Acne Drug: ACYC Drug: ACYC vehicle Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Valeant Pharmaceuticals International, Inc.:

Primary Outcome Measures:
  • 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 ]

Enrollment: 498
Study Start Date: October 2012
Study Completion Date: July 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
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


  Show 24 Study Locations
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
Dow Pharmaceutical Sciences
Investigators
Study Director: Nilima Justice, M.D. Medical Monitor, Valeant Pharmaceuticals
  More Information

Responsible Party: Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier: NCT01701024     History of Changes
Other Study ID Numbers: V01-ACYC-301
First Submitted: September 27, 2012
First Posted: October 4, 2012
Results First Submitted: January 15, 2015
Results First Posted: January 10, 2017
Last Update Posted: January 10, 2017
Last Verified: January 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Valeant Pharmaceuticals International, Inc.:
Acne