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

NCT ID: NCT01701024

Last Updated: 2018-06-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

498 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-07-31

Brief Summary

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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

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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

Conditions

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Acne

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ACYC

ACYC active, topically applied to the face for 12 weeks

Group Type ACTIVE_COMPARATOR

ACYC

Intervention Type DRUG

ACYC active, topically applied to the face for 12 weeks

ACYC vehicle

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

Group Type PLACEBO_COMPARATOR

ACYC vehicle

Intervention Type DRUG

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

Interventions

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ACYC

ACYC active, topically applied to the face for 12 weeks

Intervention Type DRUG

ACYC vehicle

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

Intervention Type DRUG

Eligibility Criteria

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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

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
Minimum Eligible Age

12 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dow Pharmaceutical Sciences

INDUSTRY

Sponsor Role collaborator

Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nilima Justice, M.D.

Role: STUDY_DIRECTOR

Medical Monitor, Valeant Pharmaceuticals

Locations

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Mobile, Alabama, United States

Site Status

Los Angeles, California, United States

Site Status

San Diego, California, United States

Site Status

New Haven, Connecticut, United States

Site Status

Aventura, Florida, United States

Site Status

Naperville, Illinois, United States

Site Status

Evansville, Indiana, United States

Site Status

South Bend, Indiana, United States

Site Status

Louisville, Kentucky, United States

Site Status

Clinton Township, Michigan, United States

Site Status

Fridley, Minnesota, United States

Site Status

Omaha, Nebraska, United States

Site Status

Albuquerque, New Mexico, United States

Site Status

Rochester, New York, United States

Site Status

Raleigh, North Carolina, United States

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Portland, Oregon, United States

Site Status

Goodlettsville, Tennessee, United States

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Austin, Texas, United States

Site Status

College Station, Texas, United States

Site Status

Houston, Texas, United States

Site Status

San Antonio, Texas, United States

Site Status

Salt Lake City, Utah, United States

Site Status

Lynchburg, Virginia, United States

Site Status

Norfolk, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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V01-ACYC-301

Identifier Type: -

Identifier Source: org_study_id

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