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

This study has been completed.
Sponsor:
Information provided by:
Dow Pharmaceutical Sciences
ClinicalTrials.gov Identifier:
NCT00663286
First received: April 15, 2008
Last updated: April 18, 2008
Last verified: April 2008
  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 3

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:


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: 1399
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: NCT00663286

  Hide Study Locations
Locations
United States, Arkansas
Burke Pharmaceutical Research
Hot Springs, Arkansas, United States, 71913
United States, Connecticut
The Savin Center, PC
New Haven, Connecticut, United States, 06511
United States, Delaware
Webster Dermatology, PA
Hockessin, Delaware, United States, 19707
United States, Florida
Skin Care Research, Inc.
Boca Raton, Florida, United States, 33486
Advanced Dermatology and Cosmetic Surgery
Clermont, Florida, United States, 34711
North Florida Dermatology Associates, PA
Jacksonville, Florida, United States, 32204
Advanced Dermatology and Cosmetic Surgery
Ormond Beach, Florida, United States, 32174
Dermatology Research
Pinellas Park, Florida, United States, 33781
Florida Dermatology Institute
West Palm Beach, Florida, United States, 33401
United States, Georgia
Derm Center of Augusta
Augusta, Georgia, United States, 30904
MedaPhase Inc.
Newnan, Georgia, United States, 30263
Gwinnett Clinical Research Center, Inc.
Snellville, Georgia, United States, 30078
United States, Illinois
DuPage Medical Group
Naperville, Illinois, United States, 60563
United States, Indiana
Hudson Dermatology
Evansville, Indiana, United States, 47714
South Bend Clinic
South Bend, Indiana, United States, 46617
United States, Kentucky
Dermatology Specialists Research
Louisville, Kentucky, United States, 40202
United States, Michigan
Michigan Center for Research Corp.
Clinton Township, Michigan, United States, 48038
United States, Minnesota
Minnesota Clinical Study Center
Fridley, Minnesota, United States, 55432
United States, New York
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11203
Atlantic Dermatologic Associates, LLP
Brooklyn, New York, United States, 11234
Office of Fran E. Cook-Bolden, MD
New York, New York, United States, 10021
Helendale Dermatology and Medical Spa
Rochester, New York, United States, 14609
Dermatology Associates of Rochester
Rochester, New York, United States, 14623
DermResearch Center of New York
Stony Brook, New York, United States, 11790
United States, Oklahoma
Central Sooner Research
Norman, Oklahoma, United States, 73069
United States, Pennsylvania
Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
United States, Texas
DermResearch, Inc.
Austin, Texas, United States, 78759
J & S Studies, Inc.
Bryan, Texas, United States, 77802
Thomas J. Stephens & Associates
Carrollton, Texas, United States, 75006
Dallas Associated Dermatologists
Dallas, Texas, United States, 75246
United States, Virginia
Education & Research Foundation
Lynchburg, Virginia, United States, 24501
Virginia Clinical Research, Inc
Norfolk, Virginia, United States, 23507
United States, Wisconsin
Madison Skin & Research, Inc.
Madison, Wisconsin, United States, 53719
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, Inc.
ClinicalTrials.gov Identifier: NCT00663286     History of Changes
Other Study ID Numbers: DPSI-06-22-2006-017
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 April 16, 2014