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

Squamous Cell Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03115476
• Other study ID #: LP0084-1369
• Secondary ID: 2017-000228-85
• Status: Terminated
• Phase: Phase 3
• Start date: June 16, 2017
• Est. completion date: March 12, 2018

Study information

• Verified date: June 2019
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 563
• Est. completion date: March 12, 2018
• Est. primary completion date: March 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Actinic Keratosis
• Carcinoma
• Carcinoma, Squamous Cell
• Keratosis
• Keratosis, Actinic
• Squamous Cell Carcinoma

Intervention

Drug:
• 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.

Other:
• Vehicle gel
Vehicle to ingenol disoxate gel with no active ingredient

Locations

Country	Name	City	State
Canada	Investigational Site	Ajax	Ontario
Canada	Investigational Site	Barrie	Ontario
Canada	Investigational Site	Drummondville	Quebec
Canada	Investigational Site	Fredericton	New Brunswick
Canada	Investigational Site	London	Ontario
Canada	Investigational Site	Mississauga	Ontario
Canada	Investigational Site	Peterborough	Ontario
Canada	Investigational Site	Surrey	British Columbia
Canada	Investigational Site	Vancouver	British Columbia
Canada	Investigational Site	Waterloo	Ontario
Canada	Investigational Site	Winnipeg	Manitoba
France	Investigational Site	Chambray les Tours
France	Investigational Site	Nice
France	Investigational Site	Saint Etienne
Germany	Investigational Site	Berlin
Germany	Investigational Site	Dresden
Germany	Investigational Site	Frankfurt am Main
Germany	Investigational Site	Hamburg
Germany	Investigational Site	Hannover
Germany	Investigational Site	Münster
Germany	Investigational Site	Recklinghausen
Germany	Investigational Site	Schweinfurt
Spain	Investigational Site	Badalona	Barcelona
Spain	Investigational Site	Pamplona	Navarra
Spain	Investigational Site	Valencia
United Kingdom	Investigational Site	Airdrie	Lanarkshire
United Kingdom	Investigational Site	Dundee	Angus
United Kingdom	Investigational Site	Middlesborough	North Yorkshire
United Kingdom	Investigational Site	Redhill	Surrey
United States	Laser & Skin Surgery Center of Indiana	Carmel	Indiana
United States	Clarkston Skin Research	Clarkston	Michigan
United States	Dermatology and Dermatologic Surgery	Danbury	Connecticut
United States	Colorado Medical Research Center, Inc.	Denver	Colorado
United States	Research Institute of Deaconess Clinic	Evansville	Indiana
United States	Center for Dermatology Clinical Research, Inc.	Fremont	California
United States	AboutSkin Dermatology and DermSurgery, PC	Greenwood Village	Colorado
United States	Clinical Studies Group	Henderson	Nevada
United States	Burke Pharmaceutical Research	Hot Springs	Arkansas
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	ActivMed Practices & Research, Inc.	Methuen	Massachusetts
United States	Dermatology Specialists, Inc	Murrieta	California
United States	MedaPhase	Newnan	Georgia
United States	Dermatology Specialists, Inc.	Oceanside	California
United States	Park Avenue Dermatology	Orange Park	Florida
United States	Austin Institute for Clinical Research, Inc.	Pflugerville	Texas
United States	Contour Dermatology & Cosmetic Surgery Center	Rancho Mirage	California
United States	Skin Search of Rochester, Inc.	Rochester	New York
United States	DermAssociates, PC	Rockville	Maryland
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	Gwinnett Clinical Research Center, Inc.	Snellville	Georgia
United States	Premier Clinical Research	Spokane	Washington
United States	The Dermatology Group, P.C.	Verona	New Jersey
United States	The GW Medical Faculty Associates	Washington	District of Columbia
United States	Research Institute of the Southeast, LLC	West Palm Beach	Florida
United States	Visions Clincal Research	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	From Visit 2 (6 months after Month 14 of main trial) to first SCC in the treatment area, up to 24 months
Secondary	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	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