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

April 18, 2008 updated by: Dow Pharmaceutical Sciences
The purpose of this study is to assess the effectiveness of IDP-110 in treating patients with acne vulgaris.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1414

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belize
      • Belize City, Belize
        • Dermatology and Skin Surgery Centre
  • Canada
    • Ontario
      • New London, Ontario, Canada, N5X 2P1
        • Mediprobe Research
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35205
        • Total Skin And Beauty Dermatology Center
      • Birmingham, Alabama, United States, 35233
        • University of Alabama, Birmingham
      • Huntsville, Alabama, United States, 35801
        • Medical Affiliated Research Center, Inc.
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Dermatology Research of Arkansas
    • California
      • San Diego, California, United States, 92123
        • Therapeutics Clinical Research
      • San Diego, California, United States, 92108
        • Affiliated Research Institute - Dermatology
      • San Diego, California, United States, 92123
        • University of California, San Diego, Pediatric and Adolescent Dermatology
      • Vallejo, California, United States, 94589
        • Solano Clinical Research
      • Vista, California, United States, 92083
        • Dermatology Specialists, Inc.
      • West Santa Monica, California, United States, 90404-2115
        • Clinical Research Specialists
    • Colorado
      • Denver, Colorado, United States, 80246
        • Cherry Creek Dermatology Research Inc.
      • Longmont, Colorado, United States, 80501
        • Longmont Medical Research Network
    • Florida
      • Miami, Florida, United States, 33175
        • FXM Research
      • Miami, Florida, United States, 33144
        • International Dermatology Research, Inc.
    • Illinois
      • Buffalo Grove, Illinois, United States, 60089
        • Office of Scott Glazer, MD
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Medical Center
    • Nevada
      • Reno, Nevada, United States, 89511
        • The Nevada Center for Dermatology
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Academic Dermatology
    • North Carolina
      • Cary, North Carolina, United States, 27511
        • Triangle Medical Research Associates
      • Hickory, North Carolina, United States, 28601
        • Unifour Medical Research Associates
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates, LLC
      • Wilmington, North Carolina, United States, 28401
        • New Haven Medical Research
    • Oregon
      • Portland, Oregon, United States, 97210
        • Northwest Cutaneous Research Specialists
      • Portland, Oregon, United States, 97223
        • Oregon Medical Center, PC
    • Tennessee
      • Goodlettsville, Tennessee, United States, 37072
        • Rivergate Dermatology
      • Knoxville, Tennessee, United States, 37922
        • Dermatology Associates
      • Nashville, Tennessee, United States, 37215
        • Tennessee Clinical Research Center
      • Nashville, Tennessee, United States, 37203
        • Dermatology Research Associates
    • Texas
      • Houston, Texas, United States, 77056
        • The Center for Skin Research
      • San Antonio, Texas, United States, 78229
        • Progressive Clinical Research
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • Dermatology Resarch Center
      • West Jordan, Utah, United States, 84088
        • Advanced Clinical Research - Jordan Valley
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209
        • Advanced Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: IDP-110
Topical application for 12 weeks
Active Comparator: 2
Drug: Clindamycin
Topical application for 12 weeks
Placebo Comparator: 4
Drug: Vehicle
Topical application for 12 weeks
Active Comparator: 3
Drug: Benzoyl peroxide
Topical application for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in number of lesions
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in global severity
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dow Pharmaceutical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

April 15, 2008

First Submitted That Met QC Criteria

April 18, 2008

First Posted (Estimate)

April 22, 2008

Study Record Updates

Last Update Posted (Estimate)

April 22, 2008

Last Update Submitted That Met QC Criteria

April 18, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DPSI-06-22-2006-012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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