Spots Global Cancer Trial Database for An Equivalence Study of Generic Ingenol Mebutate Gel 0.015% and Picato Gel 0.015% in Subjects With Actinic Keratosis
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Trial Identification
Brief Title: An Equivalence Study of Generic Ingenol Mebutate Gel 0.015% and Picato Gel 0.015% in Subjects With Actinic Keratosis
Official Title: A Multicenter Randomized Doubleblind Vehicle-controlled Parallel Comparison Study to Determine Therapeutic Equivalence of Generic Ingenol Mebutate Gel 0.015% and Picato® Gel 0.015% in Subjects With Actinic Keratosis on the Face or Scalp
Study ID: NCT03200912
Conditions
Study Description
Brief Summary: The objective of this study was to evaluate the safety and therapeutic equivalence of generic ingenol mebutate gel, 0.015% to Picato gel, 0.015% by establishing the therapeutic comparability of the two active products and the superiority of the two active products over the vehicle gel in the treatment of AK on the face and scalp.
Detailed Description: Picato® (ingenol mebutate) gel is the first and only ingenol mebutate product approved by the Food and Drug Administration (FDA) in 2012 for the topical treatment of AKs on the face and scalp (0.015% formulation) and on the trunk and extremities (0.05% formulation). The FDA approved regimen for ingenol mebutate gel, 0.015% for the treatment of AKs on the face and scalp is once-daily application of one unit dose tube for three consecutive days applied to one contiguous skin area of approximately 25 cm2 (e.g., 5 cm x 5 cm).
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Dermatology Specialists, Inc., Oceanside, California, United States
Horizons Clinical Research Ctr., LLC, Denver, Colorado, United States
The Center for Clinical and Cosmetic Research, Aventura, Florida, United States
Moore Clinical Research, Brandon, Florida, United States
Savin Medical Group Research Center, Miami Lakes, Florida, United States
Tory P. Sullivan, M.D., P.A., North Miami Beach, Florida, United States
MedaPhase, Inc., Newnan, Georgia, United States
Northwest Clinical Trials, Inc., Boise, Idaho, United States
Arlington Dermatology, Arlington Heights, Illinois, United States
Christie Clinic, LLC, Champaign, Illinois, United States
University Dermatology & Vein Clinic, LLC, Darien, Illinois, United States
Forefront Dermatology, Carmel, Indiana, United States
Dawes Fretzin Clinical Research Group, LLC, Indianapolis, Indiana, United States
The Indiana Clinical Trials Center, Plainfield, Indiana, United States
The South Bend Clinic,LLC, South Bend, Indiana, United States
Minnesota Clinical Study Center, Fridley, Minnesota, United States
MediSearch Clinical Trials, Saint Joseph, Missouri, United States
Academic Dermatology Associates, Albuquerque, New Mexico, United States
Dermatology Consulting Services, High Point, North Carolina, United States
Omega Medical Research, 400 Bald Hill Road, Warwick, RI 02886, Warwick, Rhode Island, United States
Palmetto Clinical Trial Services, Fountain Inn, South Carolina, United States
Dermatology Associates of Knoxville, PC, Knoxville, Tennessee, United States
DermReseach New Braunfels, New Braunfels, Texas, United States
Contact Details
Name: Oleg Khatsenko, PhD
Affiliation: Actavis Inc.
Role: STUDY_DIRECTOR
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