A Clinical Study Evaluating the Safety and Efficacy of IDP-115 in Patients With Rosacea
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Rosacea | Drug: IDP-115 Drug: Vehicle | Phase 2 |
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 |

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 |
- Change from baseline in the number of inflammatory lesions [ Time Frame: 12 weeks ]
- Improvement from baseline in global severity [ Time Frame: 12 weeks ]
- Change from baseline in erythema [ Time Frame: 12 weeks ]

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, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
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 |
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 |
Rosacea Skin Diseases |