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

February 16, 2012 updated by: Dow Pharmaceutical Sciences

A Phase 2, Multicenter, Randomized, Double-Blind, Dose-Ranging Study to Evaluate IDP-107 Versus Placebo in the Treatment of Severe Acne Vulgaris With Nodules

The purpose of this study is to assess the safety and effectiveness of IDP-107 in treating patients with acne vulgaris.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

366

Phase

  • Phase 2

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

  • United States
    • Arkansas
      • Hot Springs, Arkansas, United States, 71913
        • Burke Pharmaceutical Research
      • Little Rock, Arkansas, United States, 72205
        • Dermatology Research of Arkansas, PLLC
    • California
      • San Diego, California, United States, 92123
        • Rady Children's Hospital - San Diego
      • Santa Monica, California, United States, 90404
        • Clinical Science Institute
      • Vallejo, California, United States, 94589
        • Solano Clinical Research
    • Colorado
      • Denver, Colorado, United States, 80209
        • Cherry Creek Research, Inc.
    • Florida
      • Miami, Florida, United States, 33175
        • FXM Research Corp.
    • Michigan
      • Clinton Township, Michigan, United States, 48038
        • Michigan Center for Skin Care Research
      • Fort Gratiot, Michigan, United States, 48059
        • Hamzavi Dermatology
    • Minnesota
      • Fridley, Minnesota, United States, 55432
        • Minnesota Clinical Study Center
    • Nebraska
      • Omaha, Nebraska, United States, 68144
        • Skin Specialist, PC
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Academic Dermatology Associates
    • New York
      • Rochester, New York, United States, 14623
        • Dermatology Associates of Rochester
      • Stony Brook, New York, United States, 11790
        • DermResearchCenter of New York, Inc.
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina Hospitals and School of Medicine
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center
    • Oregon
      • Portland, Oregon, United States, 97210
        • Oregon Dermatology and Research Center
    • Texas
      • Arlington, Texas, United States, 76011
        • Arlington Research Center, inc.
      • Austin, Texas, United States, 78759
        • Dermresearch, Inc.
      • Bryan, Texas, United States, 77802
        • J & S Studies, Inc.
      • Houston, Texas, United States, 77056
        • The Center for Skin Research
    • Utah
      • West Jordan, Utah, United States, 84088
        • South Valley Dermatology
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Virginia Clinical Research, Inc.
    • Washington
      • Spokane, Washington, United States, 99204
        • Premier Clinical Research
    • Wisconsin
      • Madison, Wisconsin, United States, 53719
        • Madison Skin & Research, Inc.

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 and older (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 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: Low Strength IDP-107
Once a day for 12 weeks
Experimental: 2
Drug: High Strength IDP-107
Once a day for 12 weeks
Placebo Comparator: 3
Drug: Placebo Comparator
Once a day for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in the number of inflammatory lesions
Time Frame: 12 weeks
12 weeks
Improvement from baseline in global severity
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in the number of non-inflammatory lesions
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

January 1, 2008

Primary Completion (Actual)

March 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

April 23, 2008

First Submitted That Met QC Criteria

April 23, 2008

First Posted (Estimate)

April 25, 2008

Study Record Updates

Last Update Posted (Estimate)

February 20, 2012

Last Update Submitted That Met QC Criteria

February 16, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DPSI-IDP-107-P2-01

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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