A Clinical Study Evaluating the Safety and Efficacy of IDP-110 in Patients With Acne Vulgaris

NCT ID: NCT00664248

Last Updated: 2008-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1414 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Brief Summary

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The purpose of this study is to assess the effectiveness of IDP-110 in treating patients with acne vulgaris.

Detailed Description

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Conditions

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Acne Vulgaris

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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1

Group Type EXPERIMENTAL

IDP-110

Intervention Type DRUG

Topical application for 12 weeks

2

Group Type ACTIVE_COMPARATOR

Clindamycin

Intervention Type DRUG

Topical application for 12 weeks

3

Group Type ACTIVE_COMPARATOR

Benzoyl peroxide

Intervention Type DRUG

Topical application for 12 weeks

4

Group Type PLACEBO_COMPARATOR

Vehicle

Intervention Type DRUG

Topical application for 12 weeks

Interventions

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IDP-110

Topical application for 12 weeks

Intervention Type DRUG

Clindamycin

Topical application for 12 weeks

Intervention Type DRUG

Benzoyl peroxide

Topical application for 12 weeks

Intervention Type DRUG

Vehicle

Topical application for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Presence of inflammatory and non-inflammatory lesions

Exclusion Criteria

* Dermatological conditions of the face other than acne that could interfere with clinical evaluations
* Female subjects who are pregnant, nursing, planning a pregnancy, or become pregnant during the study
Minimum Eligible Age

12 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dow Pharmaceutical Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Dow Pharmaceutical Sciences

Locations

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Total Skin and Beauty Dermatology Center

Birmingham, Alabama, United States

Site Status

University of Alabama, Birmingham

Birmingham, Alabama, United States

Site Status

Medical Affiliated Research Center, Inc.

Huntsville, Alabama, United States

Site Status

Dermatology Research of Arkansas

Little Rock, Arkansas, United States

Site Status

Affiliated Research Institute - Dermatology

San Diego, California, United States

Site Status

Therapeutics Clinical Research

San Diego, California, United States

Site Status

University of California, San Diego, Pediatric and Adolescent Dermatology

San Diego, California, United States

Site Status

Solano Clinical Research

Vallejo, California, United States

Site Status

Dermatology Specialists, Inc.

Vista, California, United States

Site Status

Clinical Research Specialists

West Santa Monica, California, United States

Site Status

Cherry Creek Dermatology Research Inc.

Denver, Colorado, United States

Site Status

Longmont Medical Research Network

Longmont, Colorado, United States

Site Status

International Dermatology Research, Inc.

Miami, Florida, United States

Site Status

FXM Research

Miami, Florida, United States

Site Status

Office of Scott Glazer, MD

Buffalo Grove, Illinois, United States

Site Status

Henry Ford Medical Center

Detroit, Michigan, United States

Site Status

The Nevada Center for Dermatology

Reno, Nevada, United States

Site Status

Academic Dermatology

Albuquerque, New Mexico, United States

Site Status

Triangle Medical Research Associates

Cary, North Carolina, United States

Site Status

Unifour Medical Research Associates

Hickory, North Carolina, United States

Site Status

Wake Research Associates, LLC

Raleigh, North Carolina, United States

Site Status

New Haven Medical Research

Wilmington, North Carolina, United States

Site Status

Northwest Cutaneous Research Specialists

Portland, Oregon, United States

Site Status

Oregon Medical Center, PC

Portland, Oregon, United States

Site Status

Rivergate Dermatology

Goodlettsville, Tennessee, United States

Site Status

Dermatology Associates

Knoxville, Tennessee, United States

Site Status

Dermatology Research Associates

Nashville, Tennessee, United States

Site Status

Tennessee Clinical Research Center

Nashville, Tennessee, United States

Site Status

The Center for Skin Research

Houston, Texas, United States

Site Status

Progressive Clinical Research

San Antonio, Texas, United States

Site Status

Dermatology Resarch Center

Salt Lake City, Utah, United States

Site Status

Advanced Clinical Research - Jordan Valley

West Jordan, Utah, United States

Site Status

Advanced Healthcare

Milwaukee, Wisconsin, United States

Site Status

Dermatology and Skin Surgery Centre

Belize City, , Belize

Site Status

Mediprobe Research

New London, Ontario, Canada

Site Status

Countries

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United States Belize Canada

Other Identifiers

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DPSI-06-22-2006-012

Identifier Type: -

Identifier Source: org_study_id