Spots Global Cancer Trial Database for A Study of Equivalence of Generic Ingenol Mebutate Gel 0.05% and Picato Gel 0.05% in Subjects With Actinic Keratosis
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: A Study of Equivalence of Generic Ingenol Mebutate Gel 0.05% and Picato Gel 0.05% in Subjects With Actinic Keratosis
Official Title: Multicenter Randomized Double-Blind Vehicle-Controlled Parallel Group Study to Determine the Therapeutic Equivalence of Generic Ingenol Mebutate Gel 0.05% and Picato® Gel 0.05% in Subjects With Actinic Keratosis on the Trunk or Extremities
Study ID: NCT02654769
Conditions
Study Description
Brief Summary: The objective of this study was to evaluate the safety and therapeutic equivalence of generic ingenol mebutate gel, 0.05% to Picato gel, 0.05% and to establish the superiority of the efficacy of these two products over the vehicle gel in the treatment of Actinic Keratosis (AK) on the trunk or extremities.
Detailed Description: Picato® (ingenol mebutate) gel is the first and only ingenol mebutate product approved by the FDA in 2012 for the topical treatment of AK(s) on the face and scalp (0.015% formulation) and on the trunk and extremities (0.05% formulation). A generic ingenol mebutate gel, 0.05% has been developed for the topical treatment of clinically typical, visible, and discrete non-hyperkeratotic, non-hypertrophic AK lesions of the trunk or extremities.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Center for Dermatology Clinical Research, Inc, Fremont, California, United States
SD Sports Medicine & Family Health Center, San Diego, California, United States
The Center for Clinical and Cosmetic Research, Aventura, 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
Moore Clinical Research, Inc., Tampa, Florida, United States
Northwest Clinical Trials, Inc., Boise, Idaho, United States
Altman Dermatology Associates, Arlington Heights, Illinois, United States
Christie Clinic, LLC, Champaign, Illinois, United States
Shideler Clinical Research Center, Carmel, Indiana, United States
Dawes Fretzin Clinical Research Group, LLC, Indianapolis, Indiana, United States
The Indiana Clinical Trials Center, Plainfield, Indiana, United States
Bettencourt Skin Center, Henderson, Nevada, United States
Union Square Dermatology, New York, New York, United States
Dermatology Consulting Services, High Point, North Carolina, United States
PMG Research of Winston-Salem, LLC, Winston-Salem, North Carolina, United States
Omega Medical Research, 400 Bald Hill Road, Warwick, RI 02886, Warwick, Rhode Island, United States
Greenville Dermatology, LLC, Greenville, South Carolina, United States
Dermatology Associates of Knoxville, PC, Knoxville, Tennessee, United States
DermResearch, Inc.Austin, Austin, Texas, United States
The Center for Skin Research, Houston, Texas, United States
Virginia Clinical Research, Norfolk, Virginia, United States
Contact Details
Name: Oleg Khatsenko, Ph.D
Affiliation: Actavis Inc.
Role: STUDY_DIRECTOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
