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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00667173
First Posted: April 25, 2008
Last Update Posted: February 20, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dow Pharmaceutical Sciences
  Purpose
The purpose of this study is to assess the safety and effectiveness of IDP-115 in treating patients with rosacea.

Condition Intervention Phase
Rosacea Drug: IDP-115 Drug: Vehicle Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Dow Pharmaceutical Sciences:

Primary Outcome Measures:
  • Change from baseline in the number of inflammatory lesions [ Time Frame: 12 weeks ]
  • Improvement from baseline in global severity [ Time Frame: 12 weeks ]

Secondary Outcome Measures:
  • Change from baseline in erythema [ Time Frame: 12 weeks ]

Enrollment: 140
Study Start Date: November 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00667173


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

Responsible Party: Dow Pharmaceutical Sciences
ClinicalTrials.gov Identifier: NCT00667173     History of Changes
Other Study ID Numbers: DPSI-IDP-115-P2-01
First Submitted: April 23, 2008
First Posted: April 25, 2008
Last Update Posted: February 20, 2012
Last Verified: February 2012

Additional relevant MeSH terms:
Rosacea
Skin Diseases