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

June 20, 2012 updated by: Dow Pharmaceutical Sciences
The purpose of this study is to evaluate the safety and efficacy of IDP-107 versus placebo in treating patients with acne vulgaris.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

180

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

  • Canada
    • Ontario
      • Barrie, Ontario, Canada, L4M 6L2
        • Ultranova Skincare
      • Richmond Hill, Ontario, Canada, L4B 1A5
        • The Centre for Dermatology and Cosmetic Surgery
      • Waterloo, Ontario, Canada, N2J 1C4
        • K. Papp Clinical Research
  • United States
    • California
      • Oceanside, California, United States, 92056
        • Dermatology Specialists, Inc.
    • Colorado
      • Denver, Colorado, United States, 80220
        • Horizons Clinical Research Center, LLC
    • Florida
      • Jacksonville, Florida, United States, 32204
        • North Florida Dermatology Associates, PA
      • Miami, Florida, United States, 33175
        • FXM Research Corp.
      • Ormond Beach, Florida, United States, 32174
        • Ameriderm Research
    • Indiana
      • Indianapolis, Indiana, United States, 46256
        • Dawes Fretzin Clinical Research Group, LLC
      • Plainfield, Indiana, United States, 46168
        • The Indiana Clinical Trials Center, PC
    • Kentucky
      • Owensboro, Kentucky, United States, 42301
        • Pedia Research LLC
    • Massachusetts
      • Haverhill, Massachusetts, United States, 01830
        • ActivMed Practices and Research, Inc.
    • Michigan
      • Fort Gratiot, Michigan, United States, 48059
        • Hamzavi Dermatology
    • Minnesota
      • Fridley, Minnesota, United States, 55432
        • Minnesota Clinical Study Center
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Comprehensive Clinical Research
    • Oregon
      • Portland, Oregon, United States, 97210
        • Oregon Dermatology and Research Center
    • Texas
      • Austin, Texas, United States, 78759
        • Dermresearch, Inc.
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • Dermatology Research Center, Inc.
      • West Jordan, Utah, United States, 84088
        • South Valley Dermatology
    • Washington
      • Spokane, Washington, United States, 99204
        • Premier Clinical Research

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 acne vulgaris on the face and neck/trunk
  • Presence of inflammatory and non-inflammatory lesions on the face

Exclusion Criteria:

  • Presence of any skin condition on the face that could interfere with clinical evaluations
  • Use of any systemic antibiotics or corticosteroids within 4 weeks prior to the Baseline visit
  • Use of any systemic retinoids, such as isotretinoin, within 3 months prior to the Baseline visit
  • Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period

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
Placebo Comparator: Placebo
Drug: Placebo
Once a day for 16 weeks
Experimental: Low Strength IDP-107
Drug: Low Strength IDP-107
Once a day for 16 weeks
Experimental: High Strength IDP-107
Drug: High Strength IDP-107
Once a day for 16 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in the number of inflammatory lesions
Time Frame: Baseline and 22 weeks
Baseline and 22 weeks
Percent of patients who achieve success for the acne global severity score
Time Frame: Baseline and 22 weeks
Baseline and 22 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in the number of non-inflammatory lesions
Time Frame: Baseline and 22 weeks
Baseline and 22 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

September 1, 2010

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

September 1, 2010

First Submitted That Met QC Criteria

September 1, 2010

First Posted (Estimate)

September 3, 2010

Study Record Updates

Last Update Posted (Estimate)

July 2, 2012

Last Update Submitted That Met QC Criteria

June 20, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DPSI-IDP-107-P2-02

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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