A Clinical Study Evaluating the Safety and Efficacy of IDP-115 in Patients With Rosacea

February 16, 2012 updated by: Dow Pharmaceutical Sciences

A Phase 2, Multi-Center, Evaluator-Blind, Randomized, Vehicle-Controlled Clinical Study to Assess the Safety and Efficacy of IDP-115 in the Treatment of Rosacea

The purpose of this study is to assess the safety and effectiveness of IDP-115 in treating patients with rosacea.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

140

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
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Medical Affiliated Research Center, Inc.
    • California
      • San Diego, California, United States, 92123
        • Therapeutics Clinical Research
      • Vallejo, California, United States, 94589
        • Solano Clinical Research
    • Colorado
      • Denver,, Colorado, United States, 80246
        • Cherry Creek Dermatology Research Inc.
    • Florida
      • Miami, Florida, United States, 33175
        • FXM Research Corp.
    • Georgia
      • Newnan, Georgia, United States, 30263
        • MedaPhase Inc.
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Medical Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Academic Dermatology Associates
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • University Dermatology Consultants, Inc.
    • Texas
      • Austin, Texas, United States, 78759
        • Dermresearch, 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Presence of facial rosacea
  • Presence of inflammatory lesions

Exclusion Criteria:

  • Dermatological conditions of the face that could interfere with clinical evaluations
  • Known history of photosensitivity disorders (such as lupus erythematosus or polymorphous light eruption)
  • 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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: IDP-115
Topical application for 12 weeks
Placebo Comparator: 2
Drug: Vehicle
Topical application for 12 weeks
Placebo Comparator: 3
Drug: Vehicle
Topical application 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 erythema
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

November 1, 2007

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

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-115-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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