A Clinical Trial 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

Burke Pharmaceutical Research, Hot Springs, Arkansas 71913, United States

The Savin Center, PC, New Haven, Connecticut 06511, United States

Webster Dermatology, PA, Hockessin, Delaware 19707, United States

Florida Dermatology Institute, West Palm Beach, Florida 33401, United States

Advanced Dermatology and Cosmetic Surgery, Clermont, Florida 34711, United States

North Florida Dermatology Associates, PA, Jacksonville, Florida 32204, United States

Dermatology Research, Pinellas Park, Florida 33781, United States

Skin Care Research, Inc., Boca Raton, Florida 33486, United States

Advanced Dermatology and Cosmetic Surgery, Ormond Beach, Florida 32174, United States

MedaPhase Inc., Newnan, Georgia 30263, United States

Derm Center of Augusta, Augusta, Georgia 30904, United States

Gwinnett Clinical Research Center, Inc., Snellville, Georgia 30078, United States

DuPage Medical Group, Naperville, Illinois 60563, United States

South Bend Clinic, South Bend, Indiana 46617, United States

Hudson Dermatology, Evansville, Indiana 47714, United States

Dermatology Specialists Research, Louisville, Kentucky 40202, United States

Michigan Center for Research Corp., Clinton Township, Michigan 48038, United States

Minnesota Clinical Study Center, Fridley, Minnesota 55432, United States

Helendale Dermatology and Medical Spa, Rochester, New York 14609, United States

Office of Fran E. Cook-Bolden, MD, New York, New York 10021, United States

Dermatology Associates of Rochester, Rochester, New York 14623, United States

DermResearch Center of New York, Stony Brook, New York 11790, United States

SUNY Downstate Medical Center, Brooklyn, New York 11203, United States

Atlantic Dermatologic Associates, LLP, Brooklyn, New York 11234, United States

Central Sooner Research, Norman, Oklahoma 73069, United States

Milton S. Hershey Medical Center, Hershey, Pennsylvania 17033, United States

Dallas Associated Dermatologists, Dallas, Texas 75246, United States

Thomas J. Stephens & Associates, Carrollton, Texas 75006, United States

DermResearch, Inc., Austin, Texas 78759, United States

J & S Studies, Inc., Bryan, Texas 77802, United States

Virginia Clinical Research, Inc, Norfolk, Virginia 23507, United States

Education & Research Foundation, Lynchburg, Virginia 24501, United States

Madison Skin & Research, Inc., Madison, Wisconsin 53719, United States

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