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Spots Global Cancer Trial Database for 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

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Trial Identification

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

Study Description

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:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: Yes

Locations

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

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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