Spots Global Cancer Trial Database for A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on AK on Face or Scalp
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Trial Identification
Brief Title: A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on AK on Face or Scalp
Official Title: A Phase 3, Double-Blind, Vehicle-Controlled, Randomized, Parallel Group, Multicenter, Efficacy and Safety Study of KX2-391 Ointment 1% in Adult Subjects With Actinic Keratosis on the Face or Scalp
Study ID: NCT03285477
Conditions
Study Description
Brief Summary: This Phase III study is designed to evaluate the efficacy and safety of KX2-391 Ointment in adult participants when applied to an area of skin containing 4-8 stable, clinically typical Actinic Keratosis (AK) lesions on the face or scalp.
Detailed Description: This study was a double-blinded, multicenter, activity, and safety study of KX2-391 Ointment administered topically to the face or scalp of participants with actinic keratosis. The study consists of Screening, Treatment, Follow-up, and Recurrence Follow-up Periods. Eligible participants received 5 consecutive days of topical treatment, to be applied at the study site. Activity (lesion counts) and safety evaluations was performed.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Coastal Clinical Research, Inc., Mobile, Alabama, United States
Advanced Research Associates, Glendale, Arizona, United States
Center For Dermatology Clinical Research, Fremont, California, United States
Contour Dermatology, Rancho Mirage, California, United States
Western States Clincial Research, Inc., Wheat Ridge, Colorado, United States
Skin care Research, Inc, Boca Raton, Florida, United States
Olympian Clinical Research, Clearwater, Florida, United States
Clinical Research of South Florida, Coral Gables, Florida, United States
Leavitt Medical Associates of Florida d/b/a Ameriderm Research, Ormond Beach, Florida, United States
Arlington Dermatology, Arlington Heights, Illinois, United States
Deaconess Clinic Downtown, Evansville, Indiana, United States
The Indiana Clinical Trials Center, Plainfield, Indiana, United States
DelRicht Research, New Orleans, Louisiana, United States
ActivMed Practices & Research, Inc., Beverly, Massachusetts, United States
Minnesota Clinical Study Center, Fridley, Minnesota, United States
Skin Specialists PC, Omaha, Nebraska, United States
JDR Dermatology Research, Las Vegas, Nevada, United States
Psoriasis Treatment Center of Central New Jersey, East Windsor, New Jersey, United States
Academic Dermatology Associates, Albuquerque, New Mexico, United States
Mount Sinai Beth Israel, New York, New York, United States
Skin Search of Rochester, Inc., Rochester, New York, United States
PMG Research of Cary, Cary, North Carolina, United States
OnSite Clinical Solutions, LLC, Charlotte, North Carolina, United States
PMG Research of Winston-Salem,LLC, Winston-Salem, North Carolina, United States
CTI Clinical Research Center, Cincinnati, Ohio, United States
Synexus US, Greer, South Carolina, United States
J&S Studies, Inc., College Station, Texas, United States
Austin Institute for Clinical Research, Inc., Pflugerville, Texas, United States
Center for Clinical Studies, Webster, Texas, United States
Dermatology Research Center, Inc., Salt Lake City, Utah, United States
Contact Details
Name: Jane Fang, MD
Affiliation: Athenex, Inc.
Role: STUDY_CHAIR
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