A Dose-Ranging Study Evaluating the Safety and Efficacy of IDP-107 in Patients With Acne Vulgaris

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Dow Pharmaceutical Sciences

ClinicalTrials.gov Identifier:

NCT01194375

First received: September 1, 2010

Last updated: June 20, 2012

Last verified: June 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	September 1, 2010
Last Updated Date	June 20, 2012
Start Date ^ICMJE	September 2010
Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 1, 2010)	Change from baseline in the number of inflammatory lesions [ Time Frame: Baseline and 22 weeks ] [ Designated as safety issue: No ] Percent of patients who achieve success for the acne global severity score [ Time Frame: Baseline and 22 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01194375 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 1, 2010)	Change from baseline in the number of non-inflammatory lesions [ Time Frame: Baseline and 22 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Dose-Ranging Study Evaluating the Safety and Efficacy of IDP-107 in Patients With Acne Vulgaris
Official Title ^ICMJE	Not Provided
Brief Summary	The purpose of this study is to evaluate the safety and efficacy of IDP-107 versus placebo in treating patients with acne vulgaris.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Acne Vulgaris
Intervention ^ICMJE	Drug: Low Strength IDP-107 Once a day for 16 weeks Drug: High Strength IDP-107 Once a day for 16 weeks Drug: Placebo Once a day for 16 weeks
Study Arm (s)	Experimental: Low Strength IDP-107 Intervention: Drug: Low Strength IDP-107 Experimental: High Strength IDP-107 Intervention: Drug: High Strength IDP-107 Placebo Comparator: Placebo Intervention: Drug: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	180
Completion Date	December 2011
Primary Completion Date	December 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Presence of acne vulgaris on the face and neck/trunk Presence of inflammatory and non-inflammatory lesions on the face Exclusion Criteria: Presence of any skin condition on the face that could interfere with clinical evaluations Use of any systemic antibiotics or corticosteroids within 4 weeks prior to the Baseline visit Use of any systemic retinoids, such as isotretinoin, within 3 months prior to the Baseline visit Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period
Gender	Both
Ages	12 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, Canada

Administrative Information
NCT Number ^ICMJE	NCT01194375
Other Study ID Numbers ^ICMJE	DPSI-IDP-107-P2-02
Has Data Monitoring Committee	Not Provided
Responsible Party	Dow Pharmaceutical Sciences
Study Sponsor ^ICMJE	Dow Pharmaceutical Sciences
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Dow Pharmaceutical Sciences
Verification Date	June 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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