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

This study has been completed.

First Received on April 15, 2008. Last Updated on April 18, 2008 History of Changes

Sponsor:	Dow Pharmaceutical Sciences
Information provided by:	Dow Pharmaceutical Sciences
ClinicalTrials.gov Identifier:	NCT00664248

Purpose

The purpose of this study is to assess the effectiveness of IDP-110 in treating patients with acne vulgaris.

Condition	Intervention	Phase
Acne Vulgaris	Drug: IDP-110 Drug: Clindamycin Drug: Benzoyl peroxide Drug: Vehicle	Phase III

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

Drug Information available for: Clindamycin Clindamycin hydrochloride Clindamycin phosphate Clindamycin Palmitate Hydrochloride Clindamycin palmitate Benzoyl peroxide

U.S. FDA Resources

Further study details as provided by Dow Pharmaceutical Sciences:

Primary Outcome Measures:

Change from baseline in number of lesions [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in global severity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	1414
Study Start Date:	October 2006
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: IDP-110 Topical application for 12 weeks
Active Comparator: 2	Drug: Clindamycin Topical application for 12 weeks
Active Comparator: 3	Drug: Benzoyl peroxide Topical application for 12 weeks
Placebo Comparator: 4	Drug: Vehicle Topical application for 12 weeks

Eligibility

Ages Eligible for Study:	12 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00664248

Show 35 Study Locations

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
ClinicalTrials.gov Identifier:	NCT00664248 History of Changes
Other Study ID Numbers:	DPSI-06-22-2006-012
Study First Received:	April 15, 2008
Last Updated:	April 18, 2008
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Benzoyl Peroxide
Clindamycin
Clindamycin-2-phosphate

Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on February 12, 2012