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

Primary Purpose

Acne

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
ACYC
ACYC vehicle
Sponsored by
Bausch Health Americas, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne focused on measuring Acne

Eligibility Criteria

12 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

ACYC

ACYC vehicle

Arm Description

ACYC active, topically applied to the face for 12 weeks

ACYC vehicle (placebo), topically applied to the face for 12 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 27, 2012
Last Updated
May 2, 2018
Sponsor
Bausch Health Americas, Inc.
Collaborators
Dow Pharmaceutical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01701024
Brief Title
Clinical Study to Test the Efficacy and Safety of ACYC to Treat Moderate to Severe Acne
Acronym
ACYC
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 Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch Health Americas, Inc.
Collaborators
Dow Pharmaceutical Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne
Keywords
Acne

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
498 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACYC
Arm Type
Active Comparator
Arm Description
ACYC active, topically applied to the face for 12 weeks
Arm Title
ACYC vehicle
Arm Type
Placebo Comparator
Arm Description
ACYC vehicle (placebo), topically applied to the face for 12 weeks
Intervention Type
Drug
Intervention Name(s)
ACYC
Intervention Description
ACYC active, topically applied to the face for 12 weeks
Intervention Type
Drug
Intervention Name(s)
ACYC vehicle
Intervention Description
ACYC vehicle (placebo), topically applied to the face for 12 weeks
Primary Outcome Measure Information:
Title
Absolute Change in Inflammatory Lesion Count
Time Frame
Baseline and 12 Weeks
Title
Absolute Change in Non-inflammatory Lesion Count
Time Frame
Baseline and 12 Weeks
Title
Percent of Subjects Who Have a Least a 2 Grade Reduction
Time Frame
Baseline and 12 Weeks
Title
Percent of Subjects With Two Grade Reduction From Baseline and Achieving Clear or Almost Clear
Time Frame
Baseline and 12 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nilima Justice, M.D.
Organizational Affiliation
Medical Monitor, Valeant Pharmaceuticals
Official's Role
Study Director
Facility Information:
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
City
Naperville
State/Province
Illinois
ZIP/Postal Code
60563
Country
United States
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46617
Country
United States
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
City
Clinton Township
State/Province
Michigan
ZIP/Postal Code
48038
Country
United States
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68144
Country
United States
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
City
Goodlettsville
State/Province
Tennessee
ZIP/Postal Code
37072
Country
United States
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
City
College Station
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78250
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
Country
United States
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes

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

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