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

Stopped early · Phase 3

Conditions studied: Actinic Keratosis, Squamous Cell Carcinoma

In brief

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.

Key facts

Study ID

NCT03115476

Run by

LEO Pharma

People needed

563

Starts

2017-06-16

Expected to finish

2018-03-12

Last updated by the study team

2025-03-11

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed and dated informed consent has been obtained.
• 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.

You may not qualify if…

• The subject is in need of treatment with ingenol mebutate or ingenol disoxate in the selected treatment area .
• 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.

Where it is running

• 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
• Burke Pharmaceutical Research — Hot Springs, Arkansas, United States

Full record on ClinicalTrials.gov

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