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

Last updated: February 21, 2025
Sponsor: LEO Pharma
Overall Status: Terminated

Phase

3

Condition

Squamous Cell Carcinoma

Warts

Cancer

Treatment

Vehicle gel

ingenol disoxate gel 0.018%

ingenol disoxate gel 0.037%

Clinical Study ID

NCT03115476
LP0084-1369
2017-000228-85
  • All Genders

Study 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

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

Exclusion Criteria:

  • The subject is in need of treatment with ingenol mebutate or ingenol disoxate in theselected 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 theselected treatment area after end of follow-up visit (month 14) in one of the trialsLP0084-1193, -1194, -1195, or -1196 and until participation in the current trial.

  • The subject has been enrolled in any other interventional clinical trial after endof 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

Total Participants: 563
Treatment Group(s): 3
Primary Treatment: Vehicle gel
Phase: 3
Study Start date:
June 16, 2017
Estimated Completion Date:
March 12, 2018

Connect with a study center

  • Investigational Site

    Surrey, British Columbia V3R 6A7
    Canada

    Site Not Available

  • Investigational Site

    Vancouver, British Columbia V6E 4M3
    Canada

    Site Not Available

  • Investigational Site

    Winnipeg, Manitoba R3C 0N2
    Canada

    Site Not Available

  • Investigational Site

    Fredericton, New Brunswick E3B 1G9
    Canada

    Site Not Available

  • Investigational Site

    Ajax, Ontario L1S 7K8
    Canada

    Site Not Available

  • Investigational Site

    Barrie, Ontario L4M 7G1
    Canada

    Site Not Available

  • Investigational Site

    London, Ontario N6A 3H7
    Canada

    Site Not Available

  • Investigational Site

    Mississauga, Ontario L5H 1G9
    Canada

    Site Not Available

  • Investigational Site

    Peterborough, Ontario K9J 5K2
    Canada

    Site Not Available

  • Investigational Site

    Waterloo, Ontario N2J 1C4
    Canada

    Site Not Available

  • Investigational Site

    Drummondville, Quebec J2B 5L4
    Canada

    Site Not Available

  • Investigational Site

    Chambray les Tours, 37170
    France

    Site Not Available

  • Investigational Site

    Nice, 06202 Cedex 3
    France

    Site Not Available

  • Investigational Site

    Saint Etienne, 42055 Cedex 2
    France

    Site Not Available

  • Investigational Site

    Berlin, 10117
    Germany

    Site Not Available

  • Investigational Site

    Dresden, 1097
    Germany

    Site Not Available

  • Investigational Site

    Frankfurt am Main, 60590
    Germany

    Site Not Available

  • Investigational Site

    Hamburg, 22391
    Germany

    Site Not Available

  • Investigational Site

    Hannover, 30159
    Germany

    Site Not Available

  • Investigational Site

    Münster, 48149
    Germany

    Site Not Available

  • Investigational Site

    Recklinghausen, 45657
    Germany

    Site Not Available

  • Investigational Site

    Schweinfurt, 97421
    Germany

    Site Not Available

  • Investigational Site

    Modena, 41124
    Italy

    Site Not Available

  • Investigational Site

    Napoli, 80121
    Italy

    Site Not Available

  • Investigational Site

    Roma, 00189
    Italy

    Site Not Available

  • Investigational Site

    Badalona, Barcelona 08916
    Spain

    Site Not Available

  • Investigational Site

    Pamplona, Navarra 31008
    Spain

    Site Not Available

  • Investigational Site

    Valencia, 46026
    Spain

    Site Not Available

  • Investigational Site

    Dundee, Angus DD1 9SY
    United Kingdom

    Site Not Available

  • Investigational Site

    Airdrie, Lanarkshire ML6 OJS
    United Kingdom

    Site Not Available

  • Investigational Site

    Middlesborough, North Yorkshire TS4 3BW
    United Kingdom

    Site Not Available

  • Investigational Site

    Redhill, Surrey RH1 5RH
    United Kingdom

    Site Not Available

  • Burke Pharmaceutical Research

    Hot Springs, Arkansas 71913
    United States

    Site Not Available

  • Center for Dermatology Clinical Research, Inc.

    Fremont, California 94538
    United States

    Site Not Available

  • Dermatology Specialists, Inc

    Murrieta, California 92562
    United States

    Site Not Available

  • Dermatology Specialists, Inc.

    Oceanside, California 92056
    United States

    Site Not Available

  • Contour Dermatology & Cosmetic Surgery Center

    Rancho Mirage, California 92270
    United States

    Site Not Available

  • Skin Surgery Medical Group, Inc.

    San Diego, California 92117
    United States

    Site Not Available

  • Therapeutics Clinical Research

    San Diego, California 92123
    United States

    Site Not Available

  • University Clinical Trials, Inc.

    San Diego, California 92123
    United States

    Site Not Available

  • Southern California Dermatology, Inc.

    Santa Ana, California 92701
    United States

    Site Not Available

  • Colorado Medical Research Center, Inc.

    Denver, Colorado 80210
    United States

    Site Not Available

  • AboutSkin Dermatology and DermSurgery, PC

    Greenwood Village, Colorado 80111
    United States

    Site Not Available

  • Dermatology and Dermatologic Surgery

    Danbury, Connecticut 06810
    United States

    Site Not Available

  • The GW Medical Faculty Associates

    Washington, District of Columbia 20037
    United States

    Site Not Available

  • The GW Medical Faculty Associates

    Washington, D.C., District of Columbia 20037
    United States

    Site Not Available

  • Park Avenue Dermatology

    Orange Park, Florida 32073
    United States

    Site Not Available

  • Research Institute of the Southeast, LLC

    West Palm Beach, Florida 33401
    United States

    Site Not Available

  • Visions Clincal Research

    West Palm Beach, Florida 33406
    United States

    Site Not Available

  • MedaPhase

    Newnan, Georgia 30263
    United States

    Site Not Available

  • Gwinnett Clinical Research Center, Inc.

    Snellville, Georgia 30078
    United States

    Site Not Available

  • Investigational Site

    Arlington Heights, Illinois 60005
    United States

    Site Not Available

  • Laser & Skin Surgery Center of Indiana

    Carmel, Indiana 46032
    United States

    Site Not Available

  • Research Institute of Deaconess Clinic

    Evansville, Indiana 47713
    United States

    Site Not Available

  • DermAssociates, PC

    Rockville, Maryland 20850
    United States

    Site Not Available

  • ActivMed Practices & Research, Inc.

    Methuen, Massachusetts 01844
    United States

    Site Not Available

  • Clarkston Skin Research

    Clarkston, Michigan 48346
    United States

    Site Not Available

  • Clinical Studies Group

    Henderson, Nevada 89074
    United States

    Site Not Available

  • The Dermatology Group, P.C.

    Verona, New Jersey 07044
    United States

    Site Not Available

  • Skin Search of Rochester, Inc.

    Rochester, New York 14623
    United States

    Site Not Available

  • Center for Clinical Studies

    Houston, Texas 77065
    United States

    Site Not Available

  • Suzanne Bruce and Associates, P.A., The Center for Skin Research

    Katy, Texas 77494
    United States

    Site Not Available

  • Austin Institute for Clinical Research, Inc.

    Pflugerville, Texas 78660
    United States

    Site Not Available

  • Center for Clinical Studies

    Webster, Texas 77598
    United States

    Site Not Available

  • Premier Clinical Research

    Spokane, Washington 99202
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.