Rosacea Clinical Trial
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
Verified date | February 2012 |
Source | Dow Pharmaceutical Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to assess the safety and effectiveness of IDP-115 in treating patients with rosacea.
Status | Completed |
Enrollment | 140 |
Est. completion date | July 2008 |
Est. primary completion date | July 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Academic Dermatology Associates | Albuquerque | New Mexico |
United States | DermResearch, Inc. | Austin | Texas |
United States | University Dermatology Consultants, Inc. | Cincinnati | Ohio |
United States | Cherry Creek Dermatology Research Inc. | Denver, | Colorado |
United States | Henry Ford Medical Center | Detroit | Michigan |
United States | Medical Affiliated Research Center, Inc. | Huntsville | Alabama |
United States | FXM Research Corp. | Miami | Florida |
United States | MedaPhase Inc. | Newnan | Georgia |
United States | Therapeutics Clinical Research | San Diego | California |
United States | Solano Clinical Research | Vallejo | California |
Lead Sponsor | Collaborator |
---|---|
Dow Pharmaceutical Sciences |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in the number of inflammatory lesions | 12 weeks | No | |
Primary | Improvement from baseline in global severity | 12 weeks | No | |
Secondary | Change from baseline in erythema | 12 weeks | No |
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