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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
563
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 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 to ingenol disoxate gel with no active ingredient
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
Time to First Squamous Cell Carcinoma (SCC) in the Treatment Area
Time to first squamous cell carcinoma (SCC) in the treatment area. Relative difference between groups (ingenol disoxate vs vehicle) expressed as hazard ratio. The indicated measured values are the observed incidence rates of the SCC in the treatment area which form the basis of the statistical analysis of the time to event analysis
Time frame: From Visit 2 (6 months after Month 14 of main trial) to first SCC in the treatment area, up to 24 months
Time to First Squamous Cell Carcinoma (SCC) or Other Skin Neoplasia in the Treatment Area
Time to first squamous cell carcinoma (SCC) or other skin neoplasia in the treatment area. Relative difference between groups (ingenol disoxate vs vehicle) expressed as hazard ratio. The indicated measured values are the observed incidence rates of the SCC in the treatment area which form the basis of the statistical analysis of the time to event analysis
Time frame: From Visit 2 (6 months after Month 14 of main trial) to first SCC or other skin neoplasia in the treatment area, up to 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 49 more locations