Spots Global Cancer Trial Database for A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on Actinic Keratosis on Face or Scalp (AK004)
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Trial Identification
Brief Title: A Multi-Center Study to Evaluate the Efficacy and Safety of KX2-391 Ointment 1% on Actinic Keratosis on Face or Scalp (AK004)
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: NCT03285490
Conditions
Study Description
Brief Summary: This Phase III study was designed to evaluate the efficacy and safety of KX2-391 Ointment 1% 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, efficacy, and safety study of KX2-391 ointment administered topically to the face or scalp of participants with AK. The study consisted of Screening, Treatment, Follow-up, and Recurrence Follow-up Periods. Eligible participants received up to 5 consecutive days of topical treatment. Efficacy (lesion counts) and safety evaluations were performed.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Alliance Dermatology, Phoenix, Arizona, United States
Synexus US, Tucson, Arizona, United States
Burke Pharmaceutical Research, Hot Springs, Arkansas, United States
Dermatology Specialists, Inc., Murrieta, California, United States
Dermatology Specialists, Inc., Oceanside, California, United States
Skin Surgery Medical Group, Inc., San Diego, California, United States
Synexus, Santa Rosa, California, United States
AboutSkin Dermatology, Greenwood Village, Colorado, United States
Study Protocol, Inc, Boynton Beach, Florida, United States
Sweet Hope Research Specialty, Inc., Miami Lakes, Florida, United States
Forward Clinical Trials, Inc., Tampa, Florida, United States
Laser & Skin Surgery Center of Indiana, Carmel, Indiana, United States
Dawes Fretzin Clinical Research Group, Indianapolis, Indiana, United States
DS Research, Louisville, Kentucky, United States
Clinical Trials of SWLA, LLC, Lake Charles, Louisiana, United States
Hamzavi Dermatology, Fort Gratiot, Michigan, United States
Medisearch Clinical Trials, Saint Joseph, Missouri, United States
Henderson Dermatology Research, Henderson, Nevada, United States
Activmed Practices & Research, Inc, Portsmouth, New Hampshire, United States
Union Square Laser Dermatology, New York, New York, United States
Aventiv Research Inc., Dublin, Ohio, United States
Oregon Medical Research Center, Portland, Oregon, United States
Clinical Research Center of the Carolinas, Charleston, South Carolina, United States
Dermatology Associates Of Knoxville, PC, Knoxville, Tennessee, United States
Rivergate Dermatology Clinical Research, Springfield, Tennessee, United States
DermResearch, Austin, Texas, United States
Suzanne Bruce and Associates, P.A., The Center for Skin Research, Houston, Texas, United States
Clinical Trials of Texas, Inc., San Antonio, Texas, United States
The Education & Research Foundation, Inc., Lynchburg, Virginia, United States
Dermatology Associates of Seattle, Seattle, Washington, United States
Contact Details
Name: Jane Fang, MD
Affiliation: Athenex, Inc.
Role: STUDY_CHAIR
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