A Clinical Study Evaluating the Safety and Efficacy of IDP-115 in Patients With Rosacea
This study has been completed.
Sponsor:
Dow Pharmaceutical Sciences
Information provided by (Responsible Party):
Dow Pharmaceutical Sciences
ClinicalTrials.gov Identifier:
NCT00667173
First received: April 23, 2008
Last updated: February 16, 2012
Last verified: February 2012
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (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 ] [ Designated as safety issue: No ]
- Improvement from baseline in global severity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change from baseline in erythema [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| 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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00667173
Please refer to this study by its ClinicalTrials.gov identifier: 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
No publications provided
| Responsible Party: | Dow Pharmaceutical Sciences |
| ClinicalTrials.gov Identifier: | NCT00667173 History of Changes |
| Other Study ID Numbers: | DPSI-IDP-115-P2-01 |
| Study First Received: | April 23, 2008 |
| Last Updated: | February 16, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Rosacea Skin Diseases |
ClinicalTrials.gov processed this record on February 27, 2015