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

This study has been completed.
Sponsor:
Collaborator:
Dow Pharmaceutical Sciences
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier:
NCT01701024
First received: September 27, 2012
Last updated: February 12, 2014
Last verified: February 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
  • Absolute change in non-inflammatory lesion count [ Time Frame: Baseline and 12 Weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects who have a least a 2 grade reduction [ Time Frame: Baseline and 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent change in inflammatory lesion count [ Time Frame: Baseline and 12 Weeks ] [ Designated as safety issue: No ]
  • Percent change in non-inflammatory lesion count [ Time Frame: Baseline and 12 Weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 496
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
Placebo Comparator: ACYC vehicle
ACYC vehicle (placebo), topically applied to the face for 12 weeks
Drug: ACYC vehicle

  Eligibility

Ages Eligible for Study:   12 Years to 40 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier: NCT01701024     History of Changes
Other Study ID Numbers: V01-ACYC-301
Study First Received: September 27, 2012
Last Updated: February 12, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Valeant Pharmaceuticals International, Inc.:
Acne

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases

ClinicalTrials.gov processed this record on September 14, 2014