A Clinical Study Evaluating the Safety and Efficacy of IDP-110 in Patients With Acne Vulgaris - Tabular View

Tracking Information
First Received Date ^ICMJE	April 15, 2008
Last Updated Date	April 18, 2008
Start Date ^ICMJE	October 2006
Primary Completion Date	August 2007 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 18, 2008)	Change from baseline in number of lesions [ 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 NCT00664248 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 18, 2008)	Change from baseline in global severity [ 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-110 in Patients With Acne Vulgaris
Official Title ^ICMJE
Brief Summary	The purpose of this study is to assess the effectiveness of IDP-110 in treating patients with acne vulgaris.
Detailed Description
Study Phase	Phase III
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Acne Vulgaris
Intervention ^ICMJE	Drug: IDP-110 Drug: Clindamycin Drug: Benzoyl peroxide 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
Enrollment ^ICMJE	1414
Completion Date
Primary Completion Date	August 2007 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Presence of inflammatory and non-inflammatory lesions Exclusion Criteria: Dermatological conditions of the face other than acne that could interfere with clinical evaluations Female subjects who are pregnant, nursing, planning a pregnancy, or become pregnant during the study
Gender	Both
Ages	12 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Belize, Canada

Administrative Information
NCT ID ^ICMJE	NCT00664248
Responsible Party	Barry M. Calvarese, MS / Vice President, Regulatory & Clinical Affairs, Dow Pharmaceutical Sciences
Study ID Numbers ^ICMJE	DPSI-06-22-2006-012
Study Sponsor ^ICMJE	Dow Pharmaceutical Sciences
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Dow Pharmaceutical Sciences
Verification Date	April 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP