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
NCT ID: NCT03115476
Last Updated: 2025-03-11
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE3
563 participants
INTERVENTIONAL
2017-06-16
2018-03-12
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Risk of Squamous Cell Carcinoma on Skin Areas Treated With Ingenol Mebutate Gel, 0.015% and Imiquimod Cream, 5%
NCT01926496
A Sequential Treatment Regimen of Cryotherapy and Picato® for the Treatment of Actinic Keratosis on the Face and Scalp
NCT01541553
Efficacy and Safety of Ingenol Mebutate Gel for Actinic Keratosis Applied on Large Area on Face, Scalp or Chest
NCT02361216
Ingenol Mebutate 0.015% Gel in the Treatment of Actinic Keratoses (AK) on the Face and Scalp
NCT01836367
A Multicenter Study to Evaluate the Safety and Efficacy of PEP005 Topical Gel When Used to Treat Actinic Keratoses on the Head (Face or Scalp)
NCT00700063
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Ingenol disoxate gel 0.018%
ingenol disoxate gel 0.018%
Ingenol disoxate gel is a novel ingenol derivative being developed for field treatment of AKs on treatment areas of up to 250 cm2 (40 in2) on the face, chest and scalp.
Ingenol disoxate gel 0.037%
ingenol disoxate gel 0.037%
Ingenol disoxate gel is a novel ingenol derivative being developed for field treatment of AKs on treatment areas of up to 250 cm2 (40 in2) on the face, chest and scalp.
Vehicle gel
Vehicle gel
Vehicle to ingenol disoxate gel with no active ingredient
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ingenol disoxate gel 0.018%
Ingenol disoxate gel is a novel ingenol derivative being developed for field treatment of AKs on treatment areas of up to 250 cm2 (40 in2) on the face, chest and scalp.
ingenol disoxate gel 0.037%
Ingenol disoxate gel is a novel ingenol derivative being developed for field treatment of AKs on treatment areas of up to 250 cm2 (40 in2) on the face, chest and scalp.
Vehicle gel
Vehicle to ingenol disoxate gel with no active ingredient
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* The subject has been treated in one of the trials LP0084-1193, -1194, -1195, or -1196 and has been evaluated at the end of follow-up visit (month 14) of that trial.
Exclusion Criteria
* The subject is enrolled in any other interventional clinical trial.
For subjects where there is a gap between end of follow-up visit (month 14) in one of the trials LP0084-1193, -1194, -1195, or -1196 and participation in the current trial:
* The subject has been treated with ingenol mebutate or ingenol disoxate in the selected treatment area after end of follow-up visit (month 14) in one of the trials LP0084-1193, -1194, -1195, or -1196 and until participation in the current trial.
* The subject has been enrolled in any other interventional clinical trial after end of follow-up visit (month 14) in one of the trials LP0084-1193, -1194, -1195, or -1196 and until participation in the current trial.
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
LEO Pharma
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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 D.C., 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-lès-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
Hanover, , Germany
Investigational Site
Münster, , Germany
Investigational Site
Recklinghausen, , Germany
Investigational Site
Schweinfurt, , Germany
Investigational Site
Badalona, Barcelona, Spain
Investigational Site
Pamplona, Navarre, Spain
Investigational Site
Valencia, , Spain
Investigational Site
Dundee, Angus, United Kingdom
Investigational Site
Airdrie, Lanarkshire, United Kingdom
Investigational Site
Middlesbrough, North Yorkshire, United Kingdom
Investigational Site
Redhill, Surrey, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2017-000228-85
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
LP0084-1369
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.