Clinical trial NCT01701024: Clinical Study to Test the Efficacy and Safety of ACYC to Treat Moderate to Severe Acne
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acne
Keywords: Acne
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Dow Pharmaceutical Sciences
First posted: 2012-10-04
Enrollment: 498
Sex: ALL
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Absolute Change in Inflammatory Lesion Count
timeFrame: Baseline and 12 Weeks
measure: Absolute Change in Non-inflammatory Lesion Count
timeFrame: Baseline and 12 Weeks
measure: Percent of Subjects Who Have a Least a 2 Grade Reduction
timeFrame: Baseline and 12 Weeks
measure: Percent of Subjects With Two Grade Reduction From Baseline and Achieving Clear or Almost Clear
timeFrame: Baseline and 12 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Mobile
country: United States
state: Alabama
city: Los Angeles
country: United States
state: California
city: San Diego
country: United States
state: California
city: New Haven
country: United States
state: Connecticut
city: Aventura
country: United States
state: Florida
city: Naperville
country: United States
state: Illinois
city: Evansville
country: United States
state: Indiana
city: South Bend
country: United States
state: Indiana
city: Louisville
country: United States
state: Kentucky
city: Clinton Township
country: United States
state: Michigan
city: Fridley
country: United States
state: Minnesota
city: Omaha
country: United States
state: Nebraska
city: Albuquerque
country: United States
state: New Mexico
city: Rochester
country: United States
state: New York
city: Raleigh
country: United States
state: North Carolina
city: Portland
country: United States
state: Oregon
city: Goodlettsville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: College Station
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Lynchburg
country: United States
state: Virginia
city: Norfolk
country: United States
state: Virginia
Study officials:
affiliation: Medical Monitor, Valeant Pharmaceuticals
name: Nilima Justice, M.D.
role: STUDY_DIRECTOR
References: