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Sponsored by: |
Dow Pharmaceutical Sciences |
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Information provided by: | Dow Pharmaceutical Sciences |
ClinicalTrials.gov Identifier: | NCT00667173 |
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 II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
Estimated 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 |
---|---|
1: Experimental |
Drug: IDP-115
Topical application for 12 weeks
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2: Placebo Comparator |
Drug: Vehicle
Topical application for 12 weeks
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3: Placebo Comparator |
Drug: Vehicle
Topical application for 12 weeks
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |
Medical Affiliated Research Center, Inc. | |
Huntsville, Alabama, United States, 35801 | |
United States, California | |
Solano Clinical Research | |
Vallejo, California, United States, 94589 | |
Therapeutics Clinical Research | |
San Diego, California, United States, 92123 | |
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 |
Responsible Party: | Dow Pharmaceutical Sciences, Inc. ( Barry M. Calvarese, MS / Vice President, Regulatory & Clinical Affairs ) |
Study ID Numbers: | DPSI-IDP-115-P2-01 |
Study First Received: | April 23, 2008 |
Last Updated: | July 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00667173 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Rosacea Skin Diseases |
Rosacea Skin Diseases |