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Brief Title: A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Multicenter Study Comparing Diclofenac Sodium Gel, 3% to Solaraze® Gel, 3% in the Treatment of Actinic Keratosis on the Face or Bald Scalp
Official Title: A Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Multicenter Study Comparing Diclofenac Sodium Gel, 3% to Solaraze® Gel, 3% in the Treatment of Actinic Keratosis on the Face or Bald Scalp
Study ID: NCT02611804
Brief Summary: To compare the efficacy and safety profiles of Teva's Diclofenac Sodium Gel, 5% (test product) to Solaraze® (diclofenac sodium) Gel, 3% (reference product) to demonstrate the clinical equivalence and to show that the efficacy of the 2 active formulations is superior to that of vehicle in treating subjects with actinic keratosis (AK) on the face or bald scalp.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
Agave Clinical Research, Mesa, Arizona, United States
Radiant Research, Inc., Tucson, Arizona, United States
Center for Dermatology Clinical Research, Inc., Fremont, California, United States
Medical Center for Clinical Research, San Diego, California, United States
TCR Medical Corporation, San Diego, California, United States
Clinical Science Institute, Santa Monica, California, United States
Horizons Clinical Research Center, Denver, Colorado, United States
Olympian Clinical Research, Clearwater, Florida, United States
Tampa Bay Medical Research, Clearwater, Florida, United States
Renstar Medical Research, Ocala, Florida, United States
DS Research, Louisville, Kentucky, United States
Dermatology Consulting Services, High Point, North Carolina, United States
DermOne of North Carolina, Wilmington, North Carolina, United States
PMG Research of Winston-Salem, Winston-Salem, North Carolina, United States
Radiant Research, Cincinnati, Ohio, United States
Lynn Health Science Institute, Oklahoma City, Oklahoma, United States
Omega Medical Research, Warwick, Rhode Island, United States
Radiant Research, Anderson, South Carolina, United States
Greenville Dermatology, Greenville, South Carolina, United States
Dermatology Associates of Knoxville, Knoxville, Tennessee, United States
The Skin Wellness Center, Knoxville, Tennessee, United States
Tennessee Clinical Research Center, Nashville, Tennessee, United States
DermResearch, Inc., Austin, Texas, United States
The Center for Skin Research, Houston, Texas, United States
ACRC Trials, Plano, Texas, United States
Dermatology Clinical Research Center of San Antonio, San Antonio, Texas, United States
Stephen Miller, M.D., San Antonio, Texas, United States
Dermatology Research Center, Salt Lake City, Utah, United States
The Education and Research Foundation, Lynchburg, Virginia, United States
Premier Clinical Research, Spokane, Washington, United States