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

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

MedlinePlus related topics:

Acne

ChemIDplus related topics:

Benzoyl peroxide Clindamycin Clindamycin hydrochloride Clindamycin palmitate Clindamycin Palmitate Hydrochloride Clindamycin phosphate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

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

Responsible Party:	Dow Pharmaceutical Sciences ( Barry M. Calvarese, MS / Vice President, Regulatory & Clinical Affairs )
Study ID Numbers:	DPSI-06-22-2006-012
First Received:	April 15, 2008
Last Updated:	April 18, 2008
ClinicalTrials.gov Identifier:	NCT00664248
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Exanthema

Clindamycin

Facial Dermatoses

Clindamycin-2-phosphate

Facies

Skin Diseases

Benzoyl Peroxide

Sebaceous Gland Diseases

Acne Vulgaris

Additional relevant MeSH terms:

Anti-Infective Agents

Anti-Bacterial Agents

Protein Synthesis Inhibitors

Molecular Mechanisms of Pharmacological Action

Acneiform Eruptions

Therapeutic Uses

Enzyme Inhibitors

Dermatologic Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008

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