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

This study has been completed.

First Received on April 23, 2008. Last Updated on September 7, 2010 History of Changes

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Rosacea

U.S. FDA Resources

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

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
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:	Barry M. Calvarese, MS / Vice President, Regulatory & Clinical Affairs, Dow Pharmaceutical Sciences, Inc.
ClinicalTrials.gov Identifier:	NCT00667173 History of Changes
Other Study ID Numbers:	DPSI-IDP-115-P2-01
Study First Received:	April 23, 2008
Last Updated:	September 7, 2010
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Rosacea
Skin Diseases

ClinicalTrials.gov processed this record on February 12, 2012