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

NCT ID: NCT00663286

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

1399 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, Inc.

Locations

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Burke Pharmaceutical Research

Hot Springs, Arkansas, United States

Site Status

The Savin Center, PC

New Haven, Connecticut, United States

Site Status

Webster Dermatology, PA

Hockessin, Delaware, United States

Site Status

Skin Care Research, Inc.

Boca Raton, Florida, United States

Site Status

Advanced Dermatology and Cosmetic Surgery

Clermont, Florida, United States

Site Status

North Florida Dermatology Associates, PA

Jacksonville, Florida, United States

Site Status

Advanced Dermatology and Cosmetic Surgery

Ormond Beach, Florida, United States

Site Status

Dermatology Research

Pinellas Park, Florida, United States

Site Status

Florida Dermatology Institute

West Palm Beach, Florida, United States

Site Status

Derm Center of Augusta

Augusta, Georgia, United States

Site Status

MedaPhase Inc.

Newnan, Georgia, United States

Site Status

Gwinnett Clinical Research Center, Inc.

Snellville, Georgia, United States

Site Status

DuPage Medical Group

Naperville, Illinois, United States

Site Status

Hudson Dermatology

Evansville, Indiana, United States

Site Status

South Bend Clinic

South Bend, Indiana, United States

Site Status

Dermatology Specialists Research

Louisville, Kentucky, United States

Site Status

Michigan Center for Research Corp.

Clinton Township, Michigan, United States

Site Status

Minnesota Clinical Study Center

Fridley, Minnesota, United States

Site Status

SUNY Downstate Medical Center

Brooklyn, New York, United States

Site Status

Atlantic Dermatologic Associates, LLP

Brooklyn, New York, United States

Site Status

Office of Fran E. Cook-Bolden, MD

New York, New York, United States

Site Status

Helendale Dermatology and Medical Spa

Rochester, New York, United States

Site Status

Dermatology Associates of Rochester

Rochester, New York, United States

Site Status

DermResearch Center of New York

Stony Brook, New York, United States

Site Status

Central Sooner Research

Norman, Oklahoma, United States

Site Status

Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

DermResearch, Inc.

Austin, Texas, United States

Site Status

J & S Studies, Inc.

Bryan, Texas, United States

Site Status

Thomas J. Stephens & Associates

Carrollton, Texas, United States

Site Status

Dallas Associated Dermatologists

Dallas, Texas, United States

Site Status

Education & Research Foundation

Lynchburg, Virginia, United States

Site Status

Virginia Clinical Research, Inc

Norfolk, Virginia, United States

Site Status

Madison Skin & Research, Inc.

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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DPSI-06-22-2006-017

Identifier Type: -

Identifier Source: org_study_id