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

Tracking Information
First Received Date ^ICMJE	April 23, 2008
Last Updated Date	July 29, 2008
Start Date ^ICMJE	November 2007
Primary Completion Date	July 2008 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 23, 2008)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00667173 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 23, 2008)	Change from baseline in erythema [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	A Clinical Study Evaluating the Safety and Efficacy of IDP-115 in Patients With Rosacea
Official Title ^ICMJE
Brief Summary	The purpose of this study is to assess the safety and effectiveness of IDP-115 in treating patients with rosacea.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Rosacea
Intervention ^ICMJE	Drug: IDP-115 Drug: Vehicle
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	140
Completion Date	July 2008
Primary Completion Date	July 2008 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00667173
Responsible Party	Barry M. Calvarese, MS / Vice President, Regulatory & Clinical Affairs, Dow Pharmaceutical Sciences, Inc.
Study ID Numbers ^ICMJE	DPSI-IDP-115-P2-01
Study Sponsor ^ICMJE	Dow Pharmaceutical Sciences
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Dow Pharmaceutical Sciences
Verification Date	July 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP