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

This study has been completed.

Sponsored by:	Dow Pharmaceutical Sciences
Information provided by:	Dow Pharmaceutical Sciences
ClinicalTrials.gov Identifier:	NCT00667173

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 II

MedlinePlus related topics: Rosacea

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

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 ]

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
2: Placebo Comparator	Drug: Vehicle Topical application for 12 weeks
3: Placebo Comparator	Drug: Vehicle Topical application for 12 weeks

Eligibility

Criteria

Inclusion Criteria:

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

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
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

Sponsors and Collaborators

Dow Pharmaceutical Sciences

More Information

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
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Rosacea
Skin Diseases

ClinicalTrials.gov processed this record on January 16, 2009