Spots Global Cancer Trial Database for A Trial to Compare the Incidence of Squamous Cell Carcinoma (SCC) and Other Skin Neoplasia on Skin Areas Treated With Ingenol Disoxate Gel or Vehicle Gel for Actinic Keratosis on Face and Chest or Scalp
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Trial Identification
Brief Title: A Trial to Compare the Incidence of Squamous Cell Carcinoma (SCC) and Other Skin Neoplasia on Skin Areas Treated With Ingenol Disoxate Gel or Vehicle Gel for Actinic Keratosis on Face and Chest or Scalp
Official Title: Incidence of Squamous Cell Carcinoma and Other Skin Neoplasia in Subjects With Actinic Keratosis Treated With Ingenol Disoxate Gel 0.018% or 0.037%, or Vehicle Gel
Study ID: NCT03115476
Study Description
Brief Summary: One of the main reasons for treating actinic keratoses (AK) is the wish to lower the risk of progression of AK to squamous cell carcinoma (SCC). This risk is in the order of 1 per 1000 AKs per year, which is in itself a small risk, but since patients can have dozens of AKs and the disease is chronic the cumulative risk for a patient can be substantial. In this extension protocol of trials LP0084-1193, -1194, -1195 and -1196, LEO will study the incidence of SCCs and other skin neoplasia in vehicle and ingenol disoxate treated patients over a period of 2 years, so that the total follow-up time for each patient will be 3 years and 2 months.
Detailed Description:
Keywords
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Burke Pharmaceutical Research, Hot Springs, Arkansas, United States
Center for Dermatology Clinical Research, Inc., Fremont, California, United States
Dermatology Specialists, Inc, Murrieta, California, United States
Dermatology Specialists, Inc., Oceanside, California, United States
Contour Dermatology & Cosmetic Surgery Center, Rancho Mirage, California, United States
Skin Surgery Medical Group, Inc., San Diego, California, United States
Therapeutics Clinical Research, San Diego, California, United States
University Clinical Trials, Inc., San Diego, California, United States
Southern California Dermatology, Inc., Santa Ana, California, United States
Colorado Medical Research Center, Inc., Denver, Colorado, United States
AboutSkin Dermatology and DermSurgery, PC, Greenwood Village, Colorado, United States
Dermatology and Dermatologic Surgery, Danbury, Connecticut, United States
The GW Medical Faculty Associates, Washington, District of Columbia, United States
Park Avenue Dermatology, Orange Park, Florida, United States
Research Institute of the Southeast, LLC, West Palm Beach, Florida, United States
Visions Clincal Research, West Palm Beach, Florida, United States
MedaPhase, Newnan, Georgia, United States
Gwinnett Clinical Research Center, Inc., Snellville, Georgia, United States
Laser & Skin Surgery Center of Indiana, Carmel, Indiana, United States
Research Institute of Deaconess Clinic, Evansville, Indiana, United States
DermAssociates, PC, Rockville, Maryland, United States
ActivMed Practices & Research, Inc., Methuen, Massachusetts, United States
Clarkston Skin Research, Clarkston, Michigan, United States
Clinical Studies Group, Henderson, Nevada, United States
The Dermatology Group, P.C., Verona, New Jersey, United States
Skin Search of Rochester, Inc., Rochester, New York, United States
Center for Clinical Studies, Houston, Texas, United States
Suzanne Bruce and Associates, P.A., The Center for Skin Research, Katy, Texas, United States
Austin Institute for Clinical Research, Inc., Pflugerville, Texas, United States
Premier Clinical Research, Spokane, Washington, United States
Investigational Site, Surrey, British Columbia, Canada
Investigational Site, Vancouver, British Columbia, Canada
Investigational Site, Winnipeg, Manitoba, Canada
Investigational Site, Fredericton, New Brunswick, Canada
Investigational Site, Ajax, Ontario, Canada
Investigational Site, Barrie, Ontario, Canada
Investigational Site, London, Ontario, Canada
Investigational Site, Mississauga, Ontario, Canada
Investigational Site, Peterborough, Ontario, Canada
Investigational Site, Waterloo, Ontario, Canada
Investigational Site, Drummondville, Quebec, Canada
Investigational Site, Chambray les Tours, , France
Investigational Site, Nice, , France
Investigational Site, Saint Etienne, , France
Investigational Site, Berlin, , Germany
Investigational Site, Dresden, , Germany
Investigational Site, Frankfurt am Main, , Germany
Investigational Site, Hamburg, , Germany
Investigational Site, Hannover, , Germany
Investigational Site, Münster, , Germany
Investigational Site, Recklinghausen, , Germany
Investigational Site, Schweinfurt, , Germany
Investigational Site, Badalona, Barcelona, Spain
Investigational Site, Pamplona, Navarra, Spain
Investigational Site, Valencia, , Spain
Investigational Site, Dundee, Angus, United Kingdom
Investigational Site, Airdrie, Lanarkshire, United Kingdom
Investigational Site, Middlesborough, North Yorkshire, United Kingdom
Investigational Site, Redhill, Surrey, United Kingdom
Contact Details
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