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

Phase 3

Terminated

Conditions: Actinic Keratosis
Squamous Cell Carcinoma

Interventions: Drug: ingenol disoxate gel 0.018%
Other: Vehicle gel
Drug: ingenol disoxate gel 0.037%

Registration Number: NCT03115476

Lead Sponsor: LEO Pharma

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: Not available

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 563

Inclusion Criteria

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.

Exclusion Criteria

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ingenol disoxate gel 0.018%	ingenol disoxate gel 0.018%	-
Vehicle gel	Vehicle gel	-
Ingenol disoxate gel 0.037%	ingenol disoxate gel 0.037%	-

Primary Outcome Measures

Name	Time	Method
Time to First Squamous Cell Carcinoma (SCC) in the Treatment Area	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) 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

Secondary Outcome Measures

Name	Time	Method
Time to First Squamous Cell Carcinoma (SCC) or Other Skin Neoplasia in the Treatment Area	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	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

Trial Locations

Locations (31): DermAssociates, PC
🇺🇸
Rockville, Maryland, United States
Southern California Dermatology, Inc.
🇺🇸
Santa Ana, California, United States
Investigational Site
🇬🇧
Redhill, Surrey, United Kingdom
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
Center for Clinical Studies
🇺🇸
Houston, Texas, 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
AboutSkin Dermatology and DermSurgery, PC
🇺🇸
Greenwood Village, Colorado, 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
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
ActivMed Practices & Research, Inc.
🇺🇸
Methuen, Massachusetts, United States
Clarkston Skin Research
🇺🇸
Clarkston, Michigan, United States
Clinical Studies Group
🇺🇸
Henderson, Nevada, United States
Skin Search of Rochester, Inc.
🇺🇸
Rochester, New York, 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
The Dermatology Group, P.C.
🇺🇸
Verona, New Jersey, United States
Dermatology and Dermatologic Surgery
🇺🇸
Danbury, Connecticut, United States
Burke Pharmaceutical Research
🇺🇸
Hot Springs, Arkansas, United States
Colorado Medical Research Center, Inc.
🇺🇸
Denver, Colorado, United States
Visions Clincal Research
🇺🇸
West Palm Beach, Florida, United States