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

This study has been completed.

First Received on April 23, 2008. Last Updated on January 6, 2012 History of Changes

Sponsor:	Dow Pharmaceutical Sciences
Information provided by (Responsible Party):	Dow Pharmaceutical Sciences
ClinicalTrials.gov Identifier:	NCT00666900

Purpose

The purpose of this study is to assess the safety and effectiveness of IDP-107 in treating patients with acne vulgaris.

Condition	Intervention	Phase
Acne Vulgaris	Drug: Low Strength IDP-107 Drug: High Strength IDP-107 Drug: Placebo Comparator	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Acne

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 the number of non-inflammatory lesions [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	366
Study Start Date:	January 2008
Study Completion Date:	September 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: Low Strength IDP-107 Once a day for 12 weeks
Experimental: 2	Drug: High Strength IDP-107 Once a day for 12 weeks
Placebo Comparator: 3	Drug: Placebo Comparator Once a day for 12 weeks

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Dermatological conditions of the face that could interfere with clinical evaluations
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: NCT00666900

Sponsors and Collaborators

Dow Pharmaceutical Sciences

More Information

No publications provided

Responsible Party:	Dow Pharmaceutical Sciences
ClinicalTrials.gov Identifier:	NCT00666900 History of Changes
Other Study ID Numbers:	DPSI-IDP-107-P2-01
Study First Received:	April 23, 2008
Last Updated:	January 6, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases

ClinicalTrials.gov processed this record on February 09, 2012