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

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.
 
ClinicalTrials.gov Identifier: NCT00667173
Recruitment Status : Completed
First Posted : April 25, 2008
Last Update Posted : February 20, 2012
Sponsor:
Information provided by (Responsible Party):
Dow Pharmaceutical Sciences

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

Condition or disease Intervention/treatment Phase
Rosacea Drug: IDP-115 Drug: Vehicle Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
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
Study Start Date : November 2007
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Rosacea
MedlinePlus related topics: Rosacea

Arms and Interventions
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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


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

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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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
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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
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Dow Pharmaceutical Sciences
ClinicalTrials.gov Identifier: NCT00667173    
Other Study ID Numbers: DPSI-IDP-115-P2-01
First Posted: April 25, 2008    Key Record Dates
Last Update Posted: February 20, 2012
Last Verified: February 2012
Additional relevant MeSH terms:
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Rosacea
Skin Diseases