A Clinical Study Evaluating the Safety and Efficacy of IDP-107 in Patients With Acne Vulgaris

NCT ID: NCT00666900

Last Updated: 2012-02-20

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

PHASE2

Total Enrollment

366 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-09-30

Brief Summary

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The purpose of this study is to assess the safety and effectiveness of IDP-107 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

Low Strength IDP-107

Intervention Type DRUG

Once a day for 12 weeks

2

Group Type EXPERIMENTAL

High Strength IDP-107

Intervention Type DRUG

Once a day for 12 weeks

3

Group Type PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type DRUG

Once a day for 12 weeks

Interventions

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Low Strength IDP-107

Once a day for 12 weeks

Intervention Type DRUG

High Strength IDP-107

Once a day for 12 weeks

Intervention Type DRUG

Placebo Comparator

Once a day 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 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

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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Responsibility Role SPONSOR

Locations

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Burke Pharmaceutical Research

Hot Springs, Arkansas, United States

Site Status

Dermatology Research of Arkansas, PLLC

Little Rock, Arkansas, United States

Site Status

RADY Children's Hospital - San Diego

San Diego, California, United States

Site Status

Clinical Science Institute

Santa Monica, California, United States

Site Status

Solano Clinical Research

Vallejo, California, United States

Site Status

Cherry Creek Research, Inc.

Denver, Colorado, United States

Site Status

FXM Research Corp.

Miami, Florida, United States

Site Status

Michigan Center for Skin Care Research

Clinton Township, Michigan, United States

Site Status

Hamzavi Dermatology

Fort Gratiot, Michigan, United States

Site Status

Minnesota Clinical Study Center

Fridley, Minnesota, United States

Site Status

Skin Specialist, PC

Omaha, Nebraska, United States

Site Status

Academic Dermatology Associates

Albuquerque, New Mexico, United States

Site Status

Dermatology Associates of Rochester

Rochester, New York, United States

Site Status

DermResearchCenter of New York, Inc.

Stony Brook, New York, United States

Site Status

University of North Carolina Hospitals and School of Medicine

Chapel Hill, North Carolina, United States

Site Status

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status

Oregon Dermatology and Research Center

Portland, Oregon, United States

Site Status

Arlington Research Center, Inc.

Arlington, Texas, United States

Site Status

DermResearch, Inc.

Austin, Texas, United States

Site Status

J & S Studies, Inc.

Bryan, Texas, United States

Site Status

The Center for Skin Research

Houston, Texas, United States

Site Status

South Valley Dermatology

West Jordan, Utah, United States

Site Status

Virginia Clinical Research, Inc.

Norfolk, Virginia, United States

Site Status

Premier Clinical Research

Spokane, Washington, 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-IDP-107-P2-01

Identifier Type: -

Identifier Source: org_study_id

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