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

Condition(s) targeted: Acne Vulgaris

Intervention: IDP-110 (Drug); Clindamycin (Drug); Benzoyl peroxide (Drug); Vehicle (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Dow Pharmaceutical Sciences

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

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

Primary outcome: Change from baseline in number of lesions

Secondary outcome: Change from baseline in global severity

Minimum age: 12 Years. Maximum age: 70 Years. Gender(s): Both.

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

Dermatology and Skin Surgery Centre, Belize City, Belize

Total Skin and Beauty Dermatology Center, Birmingham, Alabama 35205, United States

University of Alabama, Birmingham, Birmingham, Alabama 35233, United States

Medical Affiliated Research Center, Inc., Huntsville, Alabama 35801, United States

Dermatology Research of Arkansas, Little Rock, Arkansas 72205, United States

University of California, San Diego, Pediatric and Adolescent Dermatology, San Diego, California 92123, United States

Solano Clinical Research, Vallejo, California 94589, United States

Affiliated Research Institute - Dermatology, San Diego, California 92108, United States

Therapeutics Clinical Research, San Diego, California 92123, United States

Dermatology Specialists, Inc., Vista, California 92083, United States

Clinical Research Specialists, West Santa Monica, California 90404-2115, United States

Longmont Medical Research Network, Longmont, Colorado 80501, United States

Cherry Creek Dermatology Research Inc., Denver, Colorado 80246, United States

International Dermatology Research, Inc., Miami, Florida 33144, United States

FXM Research, Miami, Florida 33175, United States

Office of Scott Glazer, MD, Buffalo Grove, Illinois 60089, United States

Henry Ford Medical Center, Detroit, Michigan 48202, United States

The Nevada Center for Dermatology, Reno, Nevada 89511, United States

Academic Dermatology, Albuquerque, New Mexico 87106, United States

New Haven Medical Research, Wilmington, North Carolina 28401, United States

Unifour Medical Research Associates, Hickory, North Carolina 28601, United States

Triangle Medical Research Associates, Cary, North Carolina 27511, United States

Wake Research Associates, LLC, Raleigh, North Carolina 27612, United States

Mediprobe Research, New London, Ontario N5X 2P1, Canada

Oregon Medical Center, PC, Portland, Oregon 97223, United States

Northwest Cutaneous Research Specialists, Portland, Oregon 97210, United States

Tennessee Clinical Research Center, Nashville, Tennessee 37215, United States

Dermatology Research Associates, Nashville, Tennessee 37203, United States

Rivergate Dermatology, Goodlettsville, Tennessee 37072, United States

Dermatology Associates, Knoxville, Tennessee 37922, United States

The Center for Skin Research, Houston, Texas 77056, United States

Progressive Clinical Research, San Antonio, Texas 78229, United States

Advanced Clinical Research - Jordan Valley, West Jordan, Utah 84088, United States

Dermatology Resarch Center, Salt Lake City, Utah 84124, United States

Advanced Healthcare, Milwaukee, Wisconsin 53209, United States

Starting date: October 2006
Last updated: April 18, 2008