A Randomized, Double-Blind, Multiple-Site, Placebo-Controlled, Parallel Design Study Comparing Diclofenac Sodium Gel 3% (Taro Pharmaceuticals Inc.) to Solaraze® (Diclofenac Sodium) Gel 3% (Fougera Pharms) in the Treatment of Actinic Keratosis.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Bioequivalence
Bioequivalence will be determined by evaluating the proportion of patients in the test and reference groups with 100% clearance of all AK lesions in the treatment area.
Study day 90 (30 days after completion of 60 days of treatment)
No
United States: Food and Drug Administration
DCSG 1213
NCT01742663
October 2012
December 2013
Name | Location |
---|---|
Academic Dermatology Associates | Albuquerque, New Mexico 87106 |
Tennessee Clinical Research Center | Nashville, Tennessee 37221 |
Altman Dermatology Associates | Arlington Heights, Illinois 60004 |
Medical Center for Clinical Research | San Diego, California 92108 |
Northern California Research | Sacramento, California 95821 |
Dermatology Associates of Knoxville, PC | Knoxville, Tennessee 37922 |
Northwest Clinical Trials | Boise, Idaho 83704 |
Horizons Clinical Research Center, LLC | Denver, Colorado |
FXM Research Corp. | Miami, Florida |
Dermatology Consulting Services | High Point, North Carolina |
The Indiana Clinical Trials Center, PC | Plainfield, Indiana 46168 |
FXM Research Miramar | Miramar, Florida 33027 |
Elite Clinical Studies, LLC | Phoenix, Arizona 85018 |
Silverberg Surgical and Medical Group | Newport Beach, California 92660 |
Center for Dermatology Clinical Research, Inc. | Fremont, California 94538 |
SC Clinical Research, Inc. | Garden Grove, California 92844 |
Alliance Research | Long Beach, California 90813 |
Florida Center for Dermatology, P.A. | Jacksonville, Florida 32204 |
Ormond Medical Arts Pharmaceutical Research Center | Ormond Beach, Florida 32174 |
Spencer Clinical Services | St. Petersburg, Florida 33716 |
Karl G. Heine, MD Dermatology | Henderson, Nevada 89052 |
Stephen Miller, MD, PA | San Antonio, Texas 78249 |