A Double-Blind, Randomized, Phase III, Parallel Group Study Evaluating the Efficacy and Safety of CIP-Isotretinoin in Patients With Severe Recalcitrant Nodular Acne
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Co-primary outcomes: a) Total nodular lesion count (facial and truncal); and b) Proportion of patients who achieve at least a 90% reduction in total number of nodular lesions (facial and truncal).
20 weeks
No
James J. Leyden, MD
Study Chair
University of Pennsylvania
United States: Food and Drug Administration
ISOCT.08.01
NCT00975143
September 2009
May 2011
Name | Location |
---|---|
Minnesota Clinical Study Center | Fridley, Minnesota 55432 |
Tennessee Clinical Research Center | Nashville, Tennessee 37221 |
North Florida Dermatology Associates, PA | Jacksonville, Florida 32204 |
Park Avenue Dermatology | Orange Park, Florida 32073 |
Dermatology Associates Of Knoxville | Knoxville, Tennessee 37917 |
Burke Pharmaceutical Research | Hot Springs, Arkansas 71913 |
Comprehensive Clinical Research | Berlin, New Jersey 08009 |
Arlington Center for Dermatology | Arlington, Texas 76011 |
Dermatology Research Associates | Los Angeles, California 90045 |
Hamzavi Dermatology | Fort Gratiot, Michigan 48059 |
Dermatology Research Center | Salt Lake City, Utah 84117 |
Premier Clinical Research | Spokane, Washington 99204 |
Northwest Clinical Trials | Boise, Idaho 83704 |
Skin Surgery Medical Group, Inc. | San Diego, California 92108 |
Oregon Dermatology and Research Center | Portland, Oregon 97210 |
Progressive Clinical Research | San Antonio, Texas 78229 |
Skin Specialists, PC | Omaha, Nebraska |
The Indiana Clinical Trials Center, PC | Plainfield, Indiana 46168 |
Total Skin & Beauty Dermatology Center | Birmingham, Alabama 35205 |
Center for Dermatology Clinical Research | Fremont, California 94538 |
Dermatology Specialists | Oceanside, California 92056 |
Horizons Clinical Research Center | Denver, Colorado 80220 |
Ameriderm Research | Jacksonville, Florida 32216 |
Peachtree Dermatology Associates, PC | Atlanta, Georgia 30327 |
MedaPhase Inc. | Newnan, Georgia 30263 |
Dawes Fretzin Clinical Research | Indianapolis, Indiana 46256 |
The South Bend Clinic, LLP | South Bend, Indiana 46617 |
Dermatology and Skin Cancer Specialists / Pediaresearch, LLC | Owensboro, Kentucky 42303 |
ActivMed Practices & Research | Haverhill, Massachusetts 01830 |
Great Lakes Research Group | Bay City, Michigan 48706 |
Haber Dermatology, Clinical Research Center | South Euclid, Ohio 44118 |
Paddington Testing Company Inc. | Philadelphia, Pennsylvania 19103 |
Radiant Research, Inc. | Greer, South Carolina 29651 |
Suzanne Bruce and Associates - The Center for Skin Research | Houston, Texas 77056 |
Stephen Miller, MD, PA Dermatology | San Antonio, Texas 78229 |