Clinical trial NCT03115476: 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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Actinic Keratosis
Squamous Cell Carcinoma
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2017-04-14
Enrollment: 563
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Time to First Squamous Cell Carcinoma (SCC) in the Treatment Area
timeFrame: From Visit 2 (6 months after Month 14 of main trial) to first SCC in the treatment area, up to 24 months
Secondary outcomes:
measure: Time to First Squamous Cell Carcinoma (SCC) or Other Skin Neoplasia in the Treatment Area
timeFrame: 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
Other outcomes:
Locations:
city: Hot Springs
country: United States
facility: Burke Pharmaceutical Research
state: Arkansas
city: Fremont
country: United States
facility: Center for Dermatology Clinical Research, Inc.
state: California
city: Murrieta
country: United States
facility: Dermatology Specialists, Inc
state: California
city: Oceanside
country: United States
facility: Dermatology Specialists, Inc.
state: California
city: Rancho Mirage
country: United States
facility: Contour Dermatology & Cosmetic Surgery Center
state: California
city: San Diego
country: United States
facility: Skin Surgery Medical Group, Inc.
state: California
city: San Diego
country: United States
facility: Therapeutics Clinical Research
state: California
city: San Diego
country: United States
facility: University Clinical Trials, Inc.
state: California
city: Santa Ana
country: United States
facility: Southern California Dermatology, Inc.
state: California
city: Denver
country: United States
facility: Colorado Medical Research Center, Inc.
state: Colorado
city: Greenwood Village
country: United States
facility: AboutSkin Dermatology and DermSurgery, PC
state: Colorado
city: Danbury
country: United States
facility: Dermatology and Dermatologic Surgery
state: Connecticut
city: Washington
country: United States
facility: The GW Medical Faculty Associates
state: District of Columbia
city: Orange Park
country: United States
facility: Park Avenue Dermatology
state: Florida
city: West Palm Beach
country: United States
facility: Research Institute of the Southeast, LLC
state: Florida
city: West Palm Beach
country: United States
facility: Visions Clincal Research
state: Florida
city: Newnan
country: United States
facility: MedaPhase
state: Georgia
city: Snellville
country: United States
facility: Gwinnett Clinical Research Center, Inc.
state: Georgia
city: Carmel
country: United States
facility: Laser & Skin Surgery Center of Indiana
state: Indiana
city: Evansville
country: United States
facility: Research Institute of Deaconess Clinic
state: Indiana
city: Rockville
country: United States
facility: DermAssociates, PC
state: Maryland
city: Methuen
country: United States
facility: ActivMed Practices & Research, Inc.
state: Massachusetts
city: Clarkston
country: United States
facility: Clarkston Skin Research
state: Michigan
city: Henderson
country: United States
facility: Clinical Studies Group
state: Nevada
city: Verona
country: United States
facility: The Dermatology Group, P.C.
state: New Jersey
city: Rochester
country: United States
facility: Skin Search of Rochester, Inc.
state: New York
city: Houston
country: United States
facility: Center for Clinical Studies
state: Texas
city: Katy
country: United States
facility: Suzanne Bruce and Associates, P.A., The Center for Skin Research
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute for Clinical Research, Inc.
state: Texas
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
city: Surrey
country: Canada
facility: Investigational Site
state: British Columbia
city: Vancouver
country: Canada
facility: Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Investigational Site
state: Manitoba
city: Fredericton
country: Canada
facility: Investigational Site
state: New Brunswick
city: Ajax
country: Canada
facility: Investigational Site
state: Ontario
city: Barrie
country: Canada
facility: Investigational Site
state: Ontario
city: London
country: Canada
facility: Investigational Site
state: Ontario
city: Mississauga
country: Canada
facility: Investigational Site
state: Ontario
city: Peterborough
country: Canada
facility: Investigational Site
state: Ontario
city: Waterloo
country: Canada
facility: Investigational Site
state: Ontario
city: Drummondville
country: Canada
facility: Investigational Site
state: Quebec
city: Chambray les Tours
country: France
facility: Investigational Site
city: Nice
country: France
facility: Investigational Site
city: Saint Etienne
country: France
facility: Investigational Site
city: Berlin
country: Germany
facility: Investigational Site
city: Dresden
country: Germany
facility: Investigational Site
city: Frankfurt am Main
country: Germany
facility: Investigational Site
city: Hamburg
country: Germany
facility: Investigational Site
city: Hannover
country: Germany
facility: Investigational Site
city: Münster
country: Germany
facility: Investigational Site
city: Recklinghausen
country: Germany
facility: Investigational Site
city: Schweinfurt
country: Germany
facility: Investigational Site
city: Badalona
country: Spain
facility: Investigational Site
state: Barcelona
city: Pamplona
country: Spain
facility: Investigational Site
state: Navarra
city: Valencia
country: Spain
facility: Investigational Site
city: Dundee
country: United Kingdom
facility: Investigational Site
state: Angus
city: Airdrie
country: United Kingdom
facility: Investigational Site
state: Lanarkshire
city: Middlesborough
country: United Kingdom
facility: Investigational Site
state: North Yorkshire
city: Redhill
country: United Kingdom
facility: Investigational Site
state: Surrey
Study officials:
References: